5-Aminolevulinic Acid (ALA) (20%)

• 1 x 10ml sterile amber dropper vial
• Active ingredient: 5-Aminolevulinic Acid (ALA) 20%
• Formulation: Stabilized aqueous solution for external application
• Clear to light amber in appearance
• For external use only – NOT FOR INJECTION

5-Aminolevulinic Acid (ALA) is a naturally occurring compound and a precursor in the heme biosynthesis pathway. When applied to the skin, ALA is absorbed by rapidly dividing or abnormal cells and converted to protoporphyrin IX (PpIX) — a light-sensitive molecule.

Upon exposure to specific wavelengths of light, PpIX becomes photoactivated, releasing reactive oxygen species (ROS) that selectively destroy targeted skin cells. This makes ALA a valuable agent in non-invasive skin therapies like:

• Actinic keratoses (AKs)
• Inflammatory acne
• Sun damage and photorejuvenation
• Sebaceous hyperplasia and skin texture improvement

After absorption, ALA is metabolized into protoporphyrin IX (PpIX) within the target cells. PpIX is then photoactivated using red or blue light, generating singlet oxygen and ROS, which induce selective cytotoxicity in abnormal cells without harming surrounding tissue.

• Accumulates in dysplastic or hyperproliferative cells
• Generates oxidative stress upon light activation
• Triggers controlled cell death (apoptosis)
• Enhances collagen remodeling and skin tone post-treatment

Topical ALA is well tolerated when used correctly. However, light sensitivity and temporary skin reactions are common during and after treatment.

Possible side effects include:

• Redness and swelling
• Tingling or burning sensation during light exposure
• Peeling or flaking of treated skin
• Temporary photosensitivity (24–48 hours)
• Rare: blistering, hyperpigmentation, or hypopigmentation

Side effects are usually mild to moderate and resolve within 3–5 days.

Potential Benefits:

• Non-invasive treatment for actinic keratoses and photoaging
• Clinically proven improvement in moderate to severe acne
• Enhances skin tone, texture, and appearance
• Reduces oil production and sebaceous gland activity
• Useful for pre-cancerous lesion management

⚠️ Side Effects:

• Redness, itching, or mild swelling
• Skin sensitivity to sunlight and artificial lighting for 48 hours
• Stinging or burning during light therapy

Temporary post-inflammatory pigmentation changes (rare)

• Do NOT inject – topical use only
• Contraindicated in patients with porphyria or hypersensitivity to porphyrins
• Avoid in active infections or open wounds
• Not recommended for individuals with photosensitivity disorders
• Caution in Fitzpatrick skin types IV–VI due to potential hyperpigmentation
• Sun exposure must be strictly avoided for 2 days post-treatment

Topical ALA has no systemic absorption and is unlikely to interact with medications, but caution is advised:

• Avoid combining with retinoids, peels, or abrasives within 48 hours
• Avoid concurrent use with photosensitizing drugs (e.g., tetracyclines, sulfonamides)
• Do not apply other topical products unless approved by the practitioner

There are no controlled human studies evaluating topical ALA in pregnancy or lactation. It should be avoided in pregnant or breastfeeding individuals unless deemed medically necessary and used under physician supervision.

Not recommended for pediatric use unless under the direction of a qualified dermatologist. Pediatric applications are investigational and require caution.

Topical 5-Aminolevulinic Acid (ALA) is FDA-approved in specific concentrations and formats (e.g., Levulan® Kerastick) for the treatment of actinic keratoses.

However, compounded 20% ALA solutions are not FDA-approved for general use and are considered investigational. Use is restricted to medical and cosmetic professionals.

1. Szeimies RM, et al. “Photodynamic therapy in dermatology using 5-ALA.” J Eur Acad Dermatol Venereol.
2. Gold MH, et al. “Use of ALA in acne and photodamage.” Cutis.
3. Morton CA, et al. “European consensus on PDT indications and treatment protocols.” Br J Dermatol.
4. FDA.gov – Levulan Kerastick prescribing information
5. ClinicalTrials.gov – “Topical ALA for PDT in acne and keratoses”