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ENGLISH VERSION<\/p>\n

NanoActive Alavelle™Aminolevulinic Acid Nanoliposomes<\/h2>\n

Product overview<\/p>\n

NanoActive Alavelle™<\/h2>\n

Aminolevulinic Acid Nanoliposomes \u00b7 Advanced ALA Delivery for Skin and Scalp Innovation<\/p>\n

Powered by PURISOME\u00ae FlexVes™ Liposome Technology<\/p>\n

\"\"<\/p>\n

Purui Biomedical Technology Co., Ltd. \u00b7 Innovation for Health and Beauty<\/p>\n

Product identity<\/p>\n

One active ingredient, engineered for delivery<\/h2>\n

Product name<\/p>\n

NanoActive Alavelle™ Aminolevulinic Acid Nanoliposomes<\/p>\n

Active ingredient INCI name<\/p>\n

AMINOLEVULINIC ACID<\/p>\n

Scientific identity<\/p>\n

5-Aminolevulinic acid (5-ALA)<\/p>\n

Delivery platform<\/p>\n

PURISOME\u00ae FlexVes™ Liposome Technology<\/p>\n

AMINOLEVULINIC ACID identifies the active component. The complete raw material is a multicomponent liposomal composition; see the technical documentation for the full INCI list.<\/p>\n

5-ALA is a natural biochemical precursor of protoporphyrin IX (PpIX) in the heme pathway.<\/p>\n

Application development landscape<\/p>\n

\u25a0 Sprays for facial and scalp coverage<\/p>\n

\u25a0 Topical aqueous gels<\/p>\n

\u25a0 Scalp serums and tonics<\/p>\n

\u25a0 Professional photoactivated treatments<\/p>\n

\u25a0 Daylight photodynamic applications<\/p>\n

\u25a0 Oral formulation development<\/p>\n

Why this ingredient, why now<\/p>\n

Development opportunities<\/h2>\n

5-ALA is one of the most extensively studied actives in photodynamic dermatology\u2014and one of the most challenging to formulate.<\/p>\n

4 Interconnected opportunities, one delivery platform<\/p>\n

01 Stabilize the active. Protect a pH-sensitive hydrophilic molecule within engineered vesicles, turning aqueous stability measured in days into a usable shelf life.<\/p>\n

02 Deliver where it matters. Improve transport to target skin compartments and sebum-rich follicles, rather than leaving the active on the surface.<\/p>\n

One platform, multiple formats. Sprays, gels, scalp care, professional photoactivation and daylight photodynamic applications, with a separate oral development pathway.<\/p>\n

Design for comfort. Build dose, incubation and light exposure into the protocol so efficacy and tolerability are developed together.<\/p>\n

 <\/p>\n

Mechanism of action<\/p>\n

ALA in cell biology: the heme pathway<\/h2>\n

\"\"<\/p>\n

What happens when ALA is supplied externally?<\/p>\n

Exogenous ALA bypasses the rate-limiting ALA synthase step and heme feedback control. In metabolically active cells, including sebaceous glands and proliferative epidermis, limited ferrochelatase capacity favors PpIX accumulation in target tissue.<\/p>\n

Schematic of heme biosynthesis. 5-ALA is a metabolic precursor of PpIX; it is not itself a photoactivated photosensitizer.<\/p>\n

Innovation pathways<\/p>\n

Two routes to application innovation<\/h2>\n

Route A\u2014photoactivated chemistry<\/p>\n

Vesicular delivery \u2192 intracellular PpIX \u2192 controlled illumination \u2192 photodynamic response<\/p>\n

Skin renewal and photorejuvenation: 0.5% liposomal ALA spray + IPL has been studied for wrinkles and photodamage.<\/p>\n

Pilosebaceous care: follicular delivery combined with IPL has been studied in inflammatory acne.<\/p>\n

Daylight protocols: continuous low-dose activation has clinical validation in actinic keratosis studies.<\/p>\n

Piccioni et al. | J Dermatolog Treat | 2011 \u00b7 Yeung et al. | Dermatol Surg | 2011 \u00b7 Dirschka et al. | JEADV | 2019<\/p>\n

Route B\u2014non-photodynamic combinations<\/p>\n

ALA + iron\/peptide cofactors \u2192 dermal papilla signaling \u2192 follicle research<\/p>\n

No light required. ALA combined with ferric ammonium citrate activates ERK\/AKT signaling in dermal papilla cells and supports hair-shaft elongation in ex vivo human follicles.<\/p>\n

Combination logic. Peptide (GHK) and iron partners define the studied systems; results belong to the combination, not to ALA alone.<\/p>\n

Ryu et al. | FEBS Open Bio | 2026 \u00b7 Lee et al. | Ann Dermatol | 2016 \u00b7 Morokuma et al. | Int J Dermatol | 2008<\/p>\n

Formulation science<\/p>\n

Why formulation matters: ALA is highly formulation-sensitive<\/h2>\n

1 \u00b7 A hydrophilic zwitterion facing a lipid barrier<\/p>\n

At physiological pH, ALA carries both positive and negative groups and partitions poorly into the lipid-rich stratum corneum. Unformulated aqueous ALA largely remains on the surface.<\/p>\n

2 \u00b7 pH-triggered dimerization, followed by oxidation<\/p>\n

Above approximately pH 5, the deprotonated amino group of one ALA molecule attacks another molecule\u2019s ketone group. The resulting dihydropyrazine (DHPY) oxidizes in air to inactive pyrazine (PY), with loss of PpIX-forming activity.<\/p>\n

3 \u00b7 Second-order decay that antioxidants cannot stop<\/p>\n

Degradation accelerates with the square of the free ALA concentration. Chelators and antioxidants cannot stop the primary pathway; effective controls are pH, temperature and oxygen exclusion.<\/p>\n

Measured half-life of 1% aqueous ALA (50 \u00b0C)<\/p>\n

3 h<\/p>\n

pH 7.42\u2014near physiological pH<\/p>\n

257 h<\/p>\n

pH 4.81\u2014mild acidification<\/p>\n

37 d<\/p>\n

Stable at pH 2.35\u2014fully protonated amino group<\/p>\n

The active\u2019s microenvironment\u2014pH, oxygen and molecular mobility\u2014determines shelf life. Formulation creates the challenge and provides the solution.<\/p>\n

Bunke et al. | J Pharm Sci | 2000 | PMID: 10980508 \u00b7 Elfsson et al. | Eur J Pharm Sci | 1999 | PMID: 9845784<\/p>\n

Delivery platform<\/p>\n

PURISOME\u00ae FlexVes™: an architecture for hydrophilic actives<\/h2>\n

\"\"<\/p>\n

Phospholipid bilayer membrane<\/p>\n

Aqueous core\u2014hydrophilic ALA payload<\/p>\n

Flexible, skin-compatible vesicle design<\/p>\n

What this architecture does<\/p>\n

Accommodates the payload correctly. ALA resides in aqueous and interfacial regions, associating with phospholipid headgroups rather than dissolving in oil.<\/p>\n

Stabilizes the chemistry. Restricted molecular mobility and controlled local pH slow the dimerization that degrades aqueous ALA.<\/p>\n

Prepares for delivery. A deformable lipid membrane supports partitioning into the stratum corneum and sebum-rich follicles.<\/p>\n

Published studies of liposomal ALA delivery and treatment protocols are cited as technical background for this platform class.<\/p>\n

PURISOME\u00ae FlexVes™ Liposome Technology<\/p>\n

Formulation science<\/p>\n

Stability through formulation design<\/h2>\n

01 Interfacial association. ALA associates with phospholipid headgroups, reducing free-molecule collisions that drive second-order dimerization.<\/p>\n

02 Microenvironmental pH. A mildly acidic interface keeps amino groups protonated and unable to attack neighboring ketone groups.<\/p>\n

03 Compartmentalization. Interfacial membranes restrict orientation and contact, turning one bulk phase into many isolated microenvironments.<\/p>\n

04 Locally reduced oxygen. The lipid environment limits oxygen access to DHPY intermediates, slowing irreversible oxidation to inactive PY.<\/p>\n

Published precedent. In a phospholipid nanovesicular gel containing 7.8% ALA, reported association with phosphatidylcholine polar headgroups extended stability from days in water to a shelf life of 24\u201336 months. PURISOME\u00ae vesicles apply the same physical rationale.<\/p>\n

Days Aqueous solution \u2192 24\u201336 months<\/p>\n

Reported shelf life of a 7.8% ALA nanovesicular gel<\/p>\n

Quality note: measure chemical stability (ALA content and pyrazine impurities) separately from vesicle size and appearance. Colloidal stability alone does not prove chemical stability. Antioxidants have little effect on the main condensation pathway; effective measures include pH below approximately 5 and oxygen exclusion.<\/p>\n

Reinhold | Future Oncol | 2017 | PMID: 28805092 \u00b7 Bunke et al. | J Pharm Sci | 2000 | PMID: 10980508<\/p>\n

Formulation science<\/p>\n

Aqueous vs nanovesicular systems: what changes for ALA?<\/h2>\n

Table expanded in original row order; all column labels and data are retained.<\/p>\n

\"\"<\/p>\n

Read the shelf-life row correctly: 24\u201336 months refers to that specific proprietary nanovesicular gel. It is neither a general emulsion claim nor a NanoActive Alavelle™ specification. Every formulation needs its own stability program with ALA content and pyrazine impurities as endpoints; size and appearance alone cannot prove chemical stability.<\/p>\n

Bunke et al. | J Pharm Sci | 2000 | PMID: 10980508 \u00b7 Reinhold | Future Oncol | 2017 | PMID: 28805092 \u00b7 Elfsson et al. | Eur J Pharm Sci | 1999<\/p>\n

Delivery evidence<\/p>\n

Delivery into skin and follicular compartments<\/h2>\n

\"\"<\/p>\n

Schematic: smaller vesicles can pass between corneocytes<\/p>\n

\"\"<\/p>\n

Confocal cross-sections: as particle size decreases (a \u2192 c), fluorescent material reaches deeper skin layers<\/p>\n

Particle size defines the depth budget<\/p>\n

Vesicle size and membrane deformability determine how far the carrier delivers its payload. Comparative studies show that deformable liposomes can substantially improve ALA delivery into skin.<\/p>\n

Follicles provide a fast route<\/p>\n

Hair follicles and sebaceous glands bypass the stratum corneum and extend into the dermis. Lipid vesicles readily partition into this sebum-rich environment.<\/p>\n

Local retention rather than systemic absorption<\/p>\n

The goal is retention in skin compartments where PpIX forms. After topical ALA application, plasma levels remained within normal reference ranges; delivery is intended to be local.<\/p>\n

Oh et al. | Eur J Pharm Sci | 2011 | PMID: 21782942 \u00b7 Schmitz et al. | Photodiagn Photodyn Ther | 2016 \u00b7 Rick et al. | J Photochem Photobiol B | 1997<\/p>\n

Evidence\u2014delivery<\/p>\n

Low-concentration liposomal ALA: rapid, self-limiting PpIX formation<\/h2>\n

A 0.5% liposomal ALA spray saturates skin fluorescence in approximately 2 hours, with clearance within 8 hours.<\/p>\n

\"\"<\/p>\n

Mean peak skin PpIX fluorescence, expressed as a percentage of maximum (healthy volunteers, n = 10). The source describes the protocols as statistically equivalent (P = 0.47).<\/p>\n

Plateau at about 2 h. Non-occluded 0.5% liposomal ALA reaches a fluorescence plateau after approximately two hours.<\/p>\n

Return to baseline within 8 h. The signal declines within minutes after removal and clears fully within eight hours, giving a short photosensitivity window.<\/p>\n

Comparison with 20% cream. Fluorescence continues rising for approximately eight hours after removal of the high-concentration cream, producing a longer, less controllable exposure tail.<\/p>\n

Concentrations here describe dose and kinetics, not a fold-increase in bioavailability.<\/p>\n

Christiansen et al. | Lasers Surg Med | 2007 | PMID: 17457834<\/p>\n

Mechanism\u2014light<\/p>\n

Photoactivation: PpIX photochemistry needs photons and oxygen<\/h2>\n

\"\"<\/p>\n

PpIX absorption profile: Soret band (approximately 405 nm) and Q bands (approximately 510\u2013635 nm). Schematic, not to scale.<\/p>\n

Blue light, 405\u2013417 nm<\/p>\n

Red light, 630\u2013635 nm<\/p>\n

Daylight and IPL cover the full activation spectrum<\/p>\n

1 \u00b7 Excitation. PpIX absorbs a photon and enters a long-lived triplet state.<\/p>\n

2 \u00b7 Energy transfer. Triplet PpIX transfers energy to dissolved molecular oxygen (Type II photochemistry), producing singlet oxygen and ROS.<\/p>\n

3 \u00b7 Local response. ROS act within micrometers of PpIX, mapping the response to the tissue reached by delivery.<\/p>\n

4 \u00b7 Dose rate is a design variable. Spectrum, irradiance and duration shape efficacy and comfort. Continuous low-rate daylight activation can deliver a comparable cumulative dose with much less pain than high-intensity lamps.<\/p>\n

For photochemistry and PpIX photophysics, see Bunke et al. | J Pharm Sci | 2000 and Christiansen et al. | Lasers Surg Med | 2007.<\/p>\n

Evidence\u2014skin renewal<\/p>\n

Photodynamic photorejuvenation: a measurable light dose guided by the skin<\/h2>\n

The liposomal ALA concept was developed for photodamaged skin: deliver a low-dose precursor, use skin fluorescence to indicate PpIX formation, then activate it with light.<\/p>\n

1.7 vs 1.1<\/p>\n

Mean participant-rated improvement in skin quality in a fluorescence-guided photodynamic rejuvenation study (0\u20134 scale)<\/p>\n

2007<\/p>\n

Mapping the fluorescence kinetics of 0.5% liposomal ALA in normal skin<\/p>\n

2009<\/p>\n

Fluorescence-controlled photorejuvenation: skin signals determine the light dose<\/p>\n

2011<\/p>\n

Wrinkle study: 30 participants, three liposomal ALA + IPL sessions<\/p>\n

2011<\/p>\n

A pilot study in inflammatory facial acne using the same spray + IPL approach<\/p>\n

Implication for development: spray format, a 0.5% dose and IPL use have been published together, providing a literature template for professional photoactivated skin care.<\/p>\n

Christiansen et al. | Lasers Surg Med | 2007 \u00b7 Bjerring et al. | Lasers Surg Med | 2009; 41:327\u2013336 \u00b7 Piccioni et al. | 2011 \u00b7 Yeung et al. | 2011<\/p>\n

Clinical evidence\u2014photorejuvenation<\/p>\n

Wrinkle scores fall after three 0.5% liposomal ALA + IPL sessions<\/h2>\n

\"\"<\/p>\n

Mean modified Fitzpatrick wrinkle scores (lower is milder). These are means on an ordinal scale, not direct percentage measurements of wrinkle depth.<\/p>\n

Study design<\/p>\n

30 participants with facial photodamage<\/p>\n

Three sessions of 0.5% liposomal ALA spray + IPL<\/p>\n

Three-week intervals<\/p>\n

Follow-up three months after the final session<\/p>\n

Scores improved further between the last session and follow-up, consistent with ongoing post-treatment remodeling.<\/p>\n

Piccioni et al. | J Dermatolog Treat | 2011 | DOI: 10.3109\/09546634.2011.590791 | PMID: 21801099<\/p>\n

Clinical evidence\u2014dermal remodeling<\/p>\n

Beyond wrinkle scores: the procollagen response after ALA-PDT<\/h2>\n

\"\"<\/p>\n

Mean target-antigen staining (%), paired biopsies before and one month after two ALA-PDT sessions. Values are approximate readings from Figure 2C. This is a photoactivation protocol, not evidence for unilluminated ALA.<\/p>\n

Original histology (Figure 2B): Masson\u2019s trichrome staining of dermal collagen<\/p>\n

\"\"<\/p>\n

Study protocol<\/p>\n

Two ALA-PDT sessions one month apart; 14 patients with facial actinic keratoses; 25 paired biopsies before treatment and one month afterward.<\/p>\n

Histological findings<\/p>\n

\u2191 Total dermal collagen; \u2191 type I\/III procollagen<\/p>\n

\u2191 Epidermal TGF-\u03b2 and TGF-\u03b2 receptor II<\/p>\n

\u2193 MMP-1, MMP-3 and MMP-12 (collagen-degrading enzymes)<\/p>\n

\u2193 Solar elastosis; \u2193 inflammatory infiltrates<\/p>\n

ALA-PDT \u2192 \u2191 TGF-\u03b2 \u2192 \u2191 procollagen I\/III \u2192 \u2193 MMP-1\/3\/12 \u2192 \u2193 elastosis<\/p>\n

Park MY, Sohn S, Lee ES, Kim YC | J Am Acad Dermatol | 2010;62:85\u201395 | DOI: 10.1016\/j.jaad.2009.06.025 | PMID: 19926165<\/p>\n

Clinical evidence\u2014acne<\/p>\n

Follicular delivery supports improvement in inflammatory acne<\/h2>\n

\"\"<\/p>\n

Pilosebaceous unit: the hair follicle and sebaceous gland as delivery targets<\/p>\n

Why follicles matter. Inflammatory acne is a disease of the pilosebaceous unit, a structure preferentially accessed by lipid vesicles.<\/p>\n

Delivery rationale. The lipophilic vesicle surface mixes with sebum, carrying the hydrophilic precursor down the follicular canal.<\/p>\n

Activation rationale. PpIX forms in sebaceous tissue; IPL then drives a local photodynamic response.<\/p>\n

\"\"<\/p>\n

Mean reduction in inflammatory lesion counts (%) after 0.5% liposomal ALA spray + IPL; pilot study in 12 participants.<\/p>\n

Yeung et al. | Dermatol Surg | 2011 | DOI: 10.1111\/j.1524-4725.2011.01929.x | PMID: 21414073<\/p>\n

Evidence\u2014tissue level<\/p>\n

Tissue evidence: PpIX forms where the carrier delivers ALA<\/h2>\n

\"\"<\/p>\n

Full-thickness ex vivo skin\u2014Maisch 2010<\/p>\n

An ALA nanoemulsion induced measurable PpIX fluorescence in a full-thickness skin model: the delivered precursor reached viable epidermis and was metabolized there.<\/p>\n

Ex vivo human skin comparison\u2014Schmitz 2016<\/p>\n

Formulation choice changed both epidermal ALA delivery and PpIX formation. The carrier, as well as the active, determines the tissue dose.<\/p>\n

\"\"<\/p>\n

PpIX in tissue lysates (nmol\/L, median), ex vivo human eyelid skin from 10 donors; redrawn from the reported data (Schmitz et al., 2016).<\/p>\n

Maisch et al. | Exp Dermatol | 2010 | DOI: 10.1111\/j.1600-0625.2009.01001.x \u00b7 Schmitz et al. | Photodiagn Photodyn Ther | 2016 | DOI: 10.1016\/j.pdpdt.2015.11.004<\/p>\n

Evidence\u2014imaging<\/p>\n

Imaging evidence: fluorescence follows the carrier, not just the active<\/h2>\n

Schmitz 2016, Figure 2\u2014original image<\/p>\n

Placebo<\/p>\n

Nanoemulsion gel<\/p>\n

20% cream<\/p>\n

\"\"<\/p>\n

Image labels: 3 h, 6 h and 12 h; hematoxylin & eosin; PpIX fluorescence. Columns: placebo, nanoemulsion gel, 20% cream.<\/p>\n

H&E and PpIX fluorescence cryosections; ex vivo human eyelid skin from 10 donors.<\/p>\n

Christiansen 2007, Figure 6\u2014original image<\/p>\n

Follicle\/lesion-selective signal (A) vs uniform signal (B)<\/p>\n

\"\"<\/p>\n

Measured skin-surface PpIX fluorescence: 0.5% liposomal ALA spray for 3 h without occlusion (A) vs occluded 20% ALA cream (B). The lipid carrier concentrates the signal in follicles and lesions.<\/p>\n

de Leeuw 2010, Figure 3\u2014original image<\/p>\n

Split-face comparison, one day after identical IPL settings<\/p>\n

\"\"<\/p>\n

Image labels: 0.5% 5-ALA liposomes; 20% 5-ALA cream; after IPL treatment.<\/p>\n

Non-occluded 0.5% liposomal ALA spray (left circled area) vs occluded 20% ALA cream (right). Tolerability differs with delivery and protocol, rather than with the active alone.<\/p>\n

Original images reproduced from the cited publications for scientific reference. Third-party trademarks appearing in the source images were neutralized in the supplied PPT. Microscopy supports localization, not quantitative depth measurement.<\/p>\n

Schmitz et al. | Photodiagn Photodyn Ther | 2016 | DOI: 10.1016\/j.pdpdt.2015.11.004 \u00b7 Christiansen et al. | Lasers Surg Med | 2007 | PMID: 17457834 \u00b7 de Leeuw et al. | JEADV | 2010 | DOI: 10.1111\/j.1468-3083.2009.03447.x<\/p>\n

 <\/p>\n

Protocol design<\/p>\n

Designing for efficacy and comfort together<\/h2>\n

Table expanded in original row order; all column labels and data are retained.<\/p>\n

\"\"<\/p>\n

Comfort is a property of the whole protocol\u2014formulation, incubation and illumination\u2014not encapsulation alone.<\/p>\n

Christiansen et al. | Lasers Surg Med | 2007 | PMID: 17457834 \u00b7 Dirschka et al. | JEADV | 2019 | PMID: 30022544<\/p>\n

Daylight photodynamic applications<\/p>\n

Daylight as the light source: a simple, continuous protocol<\/h2>\n

\"\"<\/p>\n

Why continuous low-intensity light can remain comfortable<\/p>\n

During two hours of daylight, PpIX is activated and photobleached almost as soon as cells synthesize it. Tissue PpIX stays at a low steady state, delivering cumulative photochemical exposure without the concentration spikes associated with treatment pain.<\/p>\n

Protocol flexibility: seasonal natural daylight or simulated-daylight lamps that avoid weather and latitude constraints, both evaluated clinically.<\/p>\n

\"\"<\/p>\n

Image label: assessment after 12 weeks.<\/p>\n

Original daylight PDT treatment schematic (Wiegell et al., 2008, Figure 1). A professional clinical protocol, not consumer sun-exposure guidance.<\/p>\n

Schematic: Wiegell et al. | Br J Dermatol | 2008 | PMID: 18294318 \u00b7 Protocol: Dirschka et al. | JEADV | 2019 | PMID: 30022544 \u00b7 Simulated daylight: Bai-Habelski et al. | 2021<\/p>\n

 <\/p>\n

Clinical evidence\u2014daylight<\/p>\n

Daylight PDT: comparable clearance, lower recurrence and very little pain<\/h2>\n

\"\"<\/p>\n

Values are percentages. Single-session daylight PDT; randomized intraindividual controlled phase III study in 52 patients with actinic keratoses. Non-inferiority P < 0.0001; recurrence difference P = 0.01.<\/p>\n

1.2 vs >4<\/p>\n

Mean maximum pain during daylight exposure (VAS 0\u201310), compared with reported mean values above 4 for conventional lamp-based PDT<\/p>\n

Reading the evidence correctly<\/p>\n

Indication: actinic keratosis, a clinical endpoint shown here as delivery-platform evidence, not cosmetic efficacy.<\/p>\n

Carrier: a phospholipid nanoemulsion gel, related to liposomal technology, clinically demonstrating daylight-compatible ALA delivery.<\/p>\n

Design: randomized split-face non-inferiority study; 52 randomized, 49 per protocol; gel = 10% ALA hydrochloride (approximately 7.8% free acid), versus 16% methyl aminolevulinate cream.<\/p>\n

Dirschka et al. | J Eur Acad Dermatol Venereol | 2019 | DOI: 10.1111\/jdv.15185 | PMID: 30022544<\/p>\n

Scalp science<\/p>\n

Follicle biology: a second home for vesicular delivery<\/h2>\n

\"\"<\/p>\n

Image labels: nanoparticle, drug; SC = stratum corneum, E = epidermis, D = dermis; dermal\u2013epidermal junction; blood vessel.<\/p>\n

Particle-delivery pathways at the follicle: surface film, follicular canal and deeper follicular penetration<\/p>\n

The follicle is a living, cycling mini-organ<\/p>\n

Dermal papilla cells at its base drive the anagen\u2013catagen\u2013telogen cycle. Their metabolic activity makes them a relevant target for active combinations.<\/p>\n

Follicles bypass the barrier<\/p>\n

The follicular canal extends into the dermis, with no mature stratum corneum in deeper regions\u2014a natural bypass available to vesicles.<\/p>\n

Sebum supports lipid vesicles<\/p>\n

The sebum-rich canal is chemically compatible with phospholipid vesicles, supporting retention and release near the papilla.<\/p>\n

This development route requires no photoactivation: the non-photodynamic track for NanoActive Alavelle™.<\/p>\n

Scalp science<\/p>\n

Inside the papilla: ERK\/AKT signaling triggered by ALA + iron<\/h2>\n

\"\"<\/p>\n

HMOX1 (HO-1) remained unchanged. Signaling involved ERK\/AKT, rather than the sometimes-assumed ALA + iron heme oxygenase pathway.<\/p>\n

Reading the evidence correctly<\/p>\n

A combination, not ALA alone. Cellular and follicular responses were observed with joint 5-ALA and iron exposure and cannot be attributed to ALA itself.<\/p>\n

Models, not patients. Immortalized dermal papilla cells and ex vivo follicle organ culture are mechanistic models. Clinical endpoints require clinical studies.<\/p>\n

Ryu et al. | FEBS Open Bio | 2026 | DOI: 10.1002\/2211-5463.70230 | PMID: 41873782<\/p>\n

Scalp science<\/p>\n

Original data from follicle models (open access)<\/h2>\n

Phospho-kinase array\u2014Figure 3A (original)<\/p>\n

\"\"<\/p>\n

Image labels: Control_spot_1\/2 and 5-ALA\/FAC_spot_1\/2. The supplied PPT image has no visible x-axis item names; none have been inferred.<\/p>\n

Relative phosphorylation in dermal papilla cells, 1 \u00b5M 5-ALA\/FAC vs control: increased kinases along the ERK\/AKT axis.<\/p>\n

Follicle organ culture\u2014Figure 4B (original)<\/p>\n

\"\"<\/p>\n

Image labels: D0\/D5 = days 0\/5; control; 5-ALA\/FAC combination; increased hair length (mm). The asterisk is the original significance marker; P < 0.05 is specified in the text.<\/p>\n

Hair-shaft elongation after five days of ex vivo human follicle organ culture, combination vs control, n = 20, P < 0.05.<\/p>\n

Original images reproduced under CC BY 4.0 (\u00a9 2026 the authors; FEBS Open Bio \/ John Wiley & Sons). Results belong to the 5-ALA + FAC combination, not ALA alone, and to model systems rather than human clinical outcomes.<\/p>\n

Ryu et al. | FEBS Open Bio | 2026;16:1527\u20131536 | DOI: 10.1002\/2211-5463.70230 | PMID: 41873782 | Open access CC BY 4.0<\/p>\n

Scalp science<\/p>\n

Three levels of hair evidence: cells, follicles and humans<\/h2>\n

Table expanded in original row order; all column labels and data are retained.<\/p>\n

\"\"<\/p>\n

What the three studies have in common<\/p>\n

Every positive hair-related result combined ALA with an iron source or peptide partner: the combination is the active principle. None used photoactivation; this is a chemistry-and-delivery pathway, not PDT.<\/p>\n

Ryu et al. | FEBS Open Bio | 2026 | PMID: 41873782 \u00b7 Lee et al. | Ann Dermatol | 2016 | PMID: 27489425 \u00b7 Morokuma et al. | Int J Dermatol | 2008 | PMID: 19126021<\/p>\n

Product formats<\/p>\n

Sprays and aqueous gels: built around vesicles<\/h2>\n

Leave-on spray<\/p>\n

Forms a thin, even film without rubbing, treating the application site gently. Covers large areas and reaches the scalp through hair. Low viscosity naturally suits aqueous vesicle dispersions.<\/p>\n

Precedent: the published liposomal ALA skin studies used spray formulations.<\/p>\n

Aqueous gel<\/p>\n

Provides longer residence at precisely targeted sites, with accurate, repeatable dosing.<\/p>\n

A water-based gel keeps hydrophilic ALA in a compatible environment while vesicles handle delivery.<\/p>\n

Formulation guardrails from the stability literature<\/p>\n

pH approximately 5\u20136. Balance ALA chemical stability with skin compatibility.<\/p>\n

Protect from oxygen and light. Packaging is part of the stability strategy.<\/p>\n

Test chemistry, not just colloids. Track ALA content and pyrazine condensation impurities; size and PDI alone cannot establish active integrity.<\/p>\n

Watch cosolvent levels. Published ALA nanoemulsion data associate excess polyols with impurity formation.<\/p>\n

Bunke et al. | J Pharm Sci | 2000 | PMID: 10980508 \u00b7 Christiansen et al. | Lasers Surg Med | 2007 | PMID: 17457834<\/p>\n

Scalp science<\/p>\n

Scalp-care concepts: the non-photodynamic route<\/h2>\n

Leave-on scalp serum<\/p>\n

A vesicle dispersion targeting the follicular canal, designed for overnight residence near the papilla\u2019s \u201cdoorway.\u201d<\/p>\n

Daily nourishing mist<\/p>\n

A lightweight aqueous formula provides broad, even coverage through hair, using a format with published precedent in ALA scalp applications.<\/p>\n

Pretreatment gel<\/p>\n

Controlled, timed contact before rinsing, for consumers who prefer a defined exposure window.<\/p>\n

Combination-first design<\/p>\n

Published hair-study results belong to ALA combined with iron or peptide partners. Formulate the concept around the combination, not ALA alone.<\/p>\n

Concepts, not specifications. These are development directions for brand partners. Concentration, packaging and shelf life depend on each partner\u2019s formulation and stability studies. None of these concepts involves photoactivation.<\/p>\n

Basis: Ryu et al. | FEBS Open Bio | 2026 | PMID: 41873782 \u00b7 Lee et al. | Ann Dermatol | 2016 | PMID: 27489425 \u00b7 Morokuma et al. | Int J Dermatol | 2008 | PMID: 19126021<\/p>\n

Professional applications<\/p>\n

Photoactivated formats: formulation, light and evidence<\/h2>\n

Table expanded in original row order; all column labels and data are retained.<\/p>\n

\"\"<\/p>\n

How Purui Biomedical positions this evidence<\/p>\n

These are professional protocols studied in clinical settings. For NanoActive Alavelle™, they provide platform evidence that low-concentration ALA in engineered carriers works under real illumination, rather than cosmetic product claims.<\/p>\n

Piccioni et al. | J Dermatolog Treat | 2011 | PMID: 21801099 \u00b7 Yeung et al. | Dermatol Surg | 2011 | PMID: 21414073 \u00b7 Dirschka et al. | JEADV | 2019 | PMID: 30022544 \u00b7 Bai-Habelski et al. | Photodiagn Photodyn Ther | 2021 | DOI: 10.1016\/j.pdpdt.2021.102692<\/p>\n

Route-specific science<\/p>\n

Another route: lessons from oral ALA pharmacokinetics<\/h2>\n

\u224860%<\/p>\n

Oral 5-ALA bioavailability in healthy volunteers<\/p>\n

\u224845 min<\/p>\n

Elimination half-life\u2014rapid systemic clearance<\/p>\n

Rapid absorption, onset and clearance: kinetics fundamentally different from a topical leave-on product.<\/p>\n

Route-specific data cannot be transferred across routes<\/p>\n

No cross-route extrapolation. Oral bioavailability and clearance do not establish topical penetration, and vesicular skin-delivery data do not establish oral exposure.<\/p>\n

A separate development program is required. Any oral concept based on ALA chemistry needs its own regulatory and clinical pathway. The PURISOME\u00ae platform discussed here targets topical delivery.<\/p>\n

Dalton et al. | J Pharmacol Exp Ther | 2002 | DOI: 10.1124\/jpet.301.2.507 | PMID: 11961050<\/p>\n

Formulator\u2019s checklist<\/p>\n

Six decisions that determine whether ALA survives and performs<\/h2>\n

Table expanded in original row order; all column labels and data are retained.<\/p>\n

\"\"<\/p>\n

Elfsson et al. | Eur J Pharm Sci | 1999 | PMID: 9845784 \u00b7 Bunke et al. | J Pharm Sci | 2000 | PMID: 10980508 \u00b7 Dalton et al. | J Pharmacol Exp Ther | 2002 | PMID: 11961050<\/p>\n

Platform overview<\/p>\n

One platform, four evidence-informed directions<\/h2>\n

Table expanded in original row order; all column labels and data are retained.<\/p>\n

\"\"<\/p>\n

Each evidence label corresponds to a full citation in the reference section. NanoActive Alavelle™ product specifications are provided by Purui Biomedical under project-specific agreements.<\/p>\n

Closing perspective<\/p>\n

One molecule, one platform, multiple thoughtfully designed formats.<\/h2>\n

01 Stabilize the chemistry<\/p>\n

Control pH and oxygen; demonstrate integrity by testing ALA and its condensation impurities.<\/p>\n

02 Deliver where it matters<\/p>\n

Flexible phospholipid vesicles carry hydrophilic ALA across the barrier and along the follicular bypass.<\/p>\n

03 Design for comfort<\/p>\n

Low loading, short contact and gentle illumination: comfort is a protocol property.<\/p>\n

Purui Biomedical Technology Co., Ltd.<\/p>\n

NanoActive Alavelle™ Aminolevulinic Acid Nanoliposomes\u2014powered by PURISOME\u00ae Liposome Technology<\/p>\n

Innovation for Health and Beauty<\/p>\n

Regulatory statement: finished products containing NanoActive Alavelle™ must comply with the laws and regulations of the countries or regions where they are manufactured and sold. The brand is responsible for final-product regulatory compliance.<\/p>\n

References<\/p>\n

References (Part 1 of 2)<\/h2>\n

01 \u00b7 Rick K, Sroka R, Stepp H, Kriegmair M, Huber RM, Jacob K, Baumgartner R. Pharmacokinetics of 5-aminolevulinic acid-induced protoporphyrin IX in skin and blood. J Photochem Photobiol B. 1997;40(3):313\u2013319. DOI: 10.1016\/S1011-1344(97)00076-6 \u00b7 PMID: 9372622<\/p>\n

02 \u00b7 Elfsson B, Wallin I, Eksborg S, Rudaeus K, Ros AM, Ehrsson H. Stability of 5-aminolevulinic acid in aqueous solution. Eur J Pharm Sci. 1999;7(2):87\u201391. DOI: 10.1016\/S0928-0987(98)00098-8 \u00b7 PMID: 9845784<\/p>\n

03 \u00b7 Bunke A, Zerbe O, Schmid H, Burmeister G, Merkle HP, Gander B. Degradation mechanism and stability of 5-aminolevulinic acid. J Pharm Sci. 2000;89(10):1335\u20131341. PMID: 10980508<\/p>\n

04 \u00b7 Dalton JT, Yates CR, Yin D, Straughn A, Marcus SL, Golub AL, Meyer MC. Clinical pharmacokinetics of 5-aminolevulinic acid in healthy volunteers and patients at high risk for recurrent bladder cancer. J Pharmacol Exp Ther. 2002;301(2):507\u2013512. DOI: 10.1124\/jpet.301.2.507 \u00b7 PMID: 11961050<\/p>\n

05 \u00b7 Christiansen K, Bjerring P, Troilius A. 5-ALA for photodynamic photorejuvenation \u2014 optimization of treatment regime based on normal-skin fluorescence measurements. Lasers Surg Med. 2007;39(4):302\u2013310. PMID: 17457834<\/p>\n

06 \u00b7 Morokuma Y, Yamazaki M, Maeda T, Yoshino I, Ishizuka M, Tanaka T, Ito Y, Tsuboi R. Hair growth stimulatory effect by a combination of 5-aminolevulinic acid and iron ion. Int J Dermatol. 2008;47(12):1298\u20131303. PMID: 19126021<\/p>\n

07 \u00b7 Bjerring P, Christiansen K, Troilius A, Bekhor P, de Leeuw J. Skin fluorescence controlled photodynamic photorejuvenation (wrinkle reduction). Lasers Surg Med. 2009;41(5):327\u2013336.<\/p>\n

08 \u00b7 Maisch T, Santarelli F, Schreml S, Babilas P, Szeimies RM. Fluorescence induction of protoporphyrin IX by a new 5-aminolevulinic acid nanoemulsion used for photodynamic therapy in a full-thickness ex vivo skin model. Exp Dermatol. 2010;19(8):e302\u2013e305. DOI: 10.1111\/j.1600-0625.2009.01001.x \u00b7 PMID: 19845760<\/p>\n

09 \u00b7 Oh EK, Jin SE, Kim JK, Park JS, Park Y, Kim CK. Retained topical delivery of 5-aminolevulinic acid using cationic ultradeformable liposomes for photodynamic therapy. Eur J Pharm Sci. 2011;44(1\u20132):149\u2013157. DOI: 10.1016\/j.ejps.2011.07.003 \u00b7 PMID: 21782942<\/p>\n

10 \u00b7 Piccioni A, Fargnoli MC, Schoinas S, Suppa M, Frascione P, Ginebri A, Chimenti S, Peris K. Efficacy and tolerability of 5-aminolevulinic acid 0.5% liposomal spray and intense pulsed light in wrinkle reduction of photodamaged skin. J Dermatolog Treat. 2011;22(5):247\u2013253. DOI: 10.3109\/09546634.2011.590791 \u00b7 PMID: 21801099<\/p>\n

References<\/p>\n

References (Part 2 of 2)<\/h2>\n

11 \u00b7 Yeung CK, Shek SY, Yu CS, Kono T, Chan HH. Liposome-encapsulated 0.5% 5-aminolevulinic acid with intense pulsed light for the treatment of inflammatory facial acne: a pilot study. Dermatol Surg. 2011;37(4):450\u2013459. DOI: 10.1111\/j.1524-4725.2011.01929.x \u00b7 PMID: 21414073<\/p>\n

12 \u00b7 Lee WJ, et al. Efficacy of a complex of 5-aminolevulinic acid and glycyl-histidyl-lysine peptide on hair growth. Ann Dermatol. 2016;28(4). PMID: 27489425<\/p>\n

13 \u00b7 Schmitz L, Novak B, Hoeh AK, Luebbert H, Dirschka T. Epidermal penetration and protoporphyrin IX formation of two different 5-aminolevulinic acid formulations in ex vivo human skin. Photodiagnosis Photodyn Ther. 2016;14:40\u201346. DOI: 10.1016\/j.pdpdt.2015.11.004 \u00b7 PMID: 26607556<\/p>\n

14 \u00b7 Ryu et al. Combined 5-aminolevulinic acid and ferric ammonium citrate treatment promotes hair follicle growth by activating dermal papilla cells. FEBS Open Bio. 2026. DOI: 10.1002\/2211-5463.70230 \u00b7 PMID: 41873782<\/p>\n

15*Reinhold U. Review of a 7.8% ALA nanoemulsion gel for the photodynamic treatment of mild-to-moderate actinic keratosis. Future Oncol. 2017;13(27):2413\u20132428. DOI: 10.2217\/fon-2017-0247 \u00b7 PMID: 28805092<\/p>\n

16*Dirschka T, Ekanayake-Bohlig S, Dominicus R, et al. Randomized, intraindividual, non-inferiority phase III study of daylight photodynamic therapy comparing a 7.8% ALA nanoemulsion gel with MAL cream in actinic keratosis. J Eur Acad Dermatol Venereol. 2019;33(2):288\u2013297. DOI: 10.1111\/jdv.15185 \u00b7 PMID: 30022544<\/p>\n

17*Bai-Habelski JC, Medrano K, Palacio A, Reinhold U. Prospective study of simulated daylight photodynamic therapy with an indoor daylight-reproducing system and a 7.8% ALA nanoemulsion gel in actinic keratosis. Photodiagnosis Photodyn Ther. 2021;37:102692. DOI: 10.1016\/j.pdpdt.2021.102692<\/p>\n

18 \u00b7 Park MY, Sohn S, Lee ES, Kim YC. Photorejuvenation induced by 5-aminolevulinic acid photodynamic therapy in patients with actinic keratosis: a histologic analysis. J Am Acad Dermatol. 2010;62(1):85\u201395. DOI: 10.1016\/j.jaad.2009.06.025 \u00b7 PMID: 19926165<\/p>\n

19de Leeuw J, van der Beek N, Bjerring P, Neumann HA. Photodynamic therapy of acne vulgaris using 5-aminolevulinic acid 0.5% liposomal spray and intense pulsed light in combination with topical keratolytic agents. J Eur Acad Dermatol Venereol. 2010;24(4):460\u2013469. DOI: 10.1111\/j.1468-3083.2009.03447.x<\/p>\n

20 \u00b7 Wiegell SR, Haedersdal M, Philipsen PA, Eriksen P, Enk CD, Wulf HC. Continuous activation of PpIX by daylight is as effective as and less painful than conventional photodynamic therapy for actinic keratoses; a randomized, controlled, single-blinded study. Br J Dermatol. 2008;158(4):740\u2013746. DOI: 10.1111\/j.1365-2133.2008.08450.x \u00b7 PMID: 18294318<\/p>\n

*Descriptive titles are used to avoid third-party trademarks in this document. Each publication can be identified uniquely by its DOI\/PMID.<\/p>\n","protected":false},"excerpt":{"rendered":"

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