What is the recommended use of Topical Aminolevulinic Acid (ALA) in treating skin conditions?

From the Guidelines

Topical aminolevulinic acid (ALA) is primarily recommended for photodynamic therapy (PDT) to treat actinic keratoses, superficial basal cell carcinomas, and certain inflammatory skin conditions like acne, with a standard protocol involving application of a 20% ALA solution and activation with blue or red light. The use of ALA-PDT has been extensively studied, with guidelines and recommendations established for its use in various skin conditions.

• For actinic keratoses, ALA-PDT has been shown to be effective, with clearance rates ranging from 71-100% after a single treatment 1.
• The standard protocol involves applying a 20% ALA solution to the affected skin areas, allowing it to absorb for 1-3 hours, then activating it with blue light (417 nm) or red light (630 nm) exposure for approximately 16-60 minutes depending on the condition being treated 1.
• For actinic keratoses, a typical regimen includes 1-3 treatment sessions spaced 2-4 weeks apart, while other conditions may require different schedules 1.
• After application, patients must strictly avoid sun exposure for 24-48 hours to prevent severe phototoxic reactions 1.
• ALA works by being metabolized to protoporphyrin IX in the skin, which accumulates preferentially in abnormal cells and, when activated by light, produces reactive oxygen species that selectively destroy these cells 1.
• Side effects typically include temporary redness, swelling, burning sensation, and crusting at the treatment site, which usually resolve within 1-2 weeks 1. The most recent and highest quality study, published in 2021, provides guidelines for the management of actinic keratosis, including the use of ALA-PDT 1.
• The study recommends the use of ALA-PDT as a treatment option for actinic keratosis, with a conditional recommendation for its use based on low-quality evidence.
• The study also notes that ALA-PDT may be less painful than other treatment options, such as cryosurgery, and may have a better cosmetic outcome. Overall, the evidence suggests that ALA-PDT is a effective and safe treatment option for actinic keratoses, superficial basal cell carcinomas, and certain inflammatory skin conditions like acne, and should be considered as a treatment option for these conditions.

From the FDA Drug Label

The clinical program for AMELUZ included three double-blind and placebo-controlled phase 3 trials (Trials 1,2, and 3), enrolling a total of 299 subjects that were treated with narrow band light. Trial subjects were adults greater than or equal to 49 years of age, and the majority had Fitzpatrick skin type I, II, or III. No subjects had Fitzpatrick skin type V or VI Approximately 86% of subjects were male, and all subjects were White. For all three phase 3 trials, the enrolled subjects had mild to moderate AKs (Olsen grade 1 and 2) with 4 to 8 lesions on the face and scalp.

The recommended use of Topical Aminolevulinic Acid (ALA) is for the treatment of actinic keratosis (AK) on the face and scalp. The maximal dose is one tube of AMELUZ (2 g) and the size of the application area is up to 20 cm2.

• Indications: Actinic keratosis (AK) on the face and scalp
• Dosage: One tube of AMELUZ (2 g)
• Application area: Up to 20 cm2
• Population: Adults greater than or equal to 49 years of age, with mild to moderate AKs (Olsen grade 1 and 2) 2 2

From the Research

Recommended Use of Topical Aminolevulinic Acid (ALA)

The recommended use of Topical Aminolevulinic Acid (ALA) in treating skin conditions includes:

• Actinic keratosis (AK) treatment, with studies showing high clearance rates 3, 4, 5, 6
• Non-melanoma skin cancers, such as Bowen's disease and superficial basal cell carcinoma, with effective treatment outcomes 3, 4, 7
• Acne vulgaris management, with demonstrated effectiveness in reducing lesions 4, 7

Application and Dosage

The application and dosage of Topical ALA vary depending on the specific condition being treated:

• For AK treatment, a 20% ALA solution or 10% ALA gel can be used, with incubation times ranging from 1-3 hours 4, 5, 6
• The use of blue-light or red-light photodynamic therapy (PDT) activation has been shown to be effective in treating AK and other skin conditions 4, 5, 7

Efficacy and Safety

Studies have demonstrated the efficacy and safety of Topical ALA in treating various skin conditions:

• High clearance rates have been reported for AK treatment, with minimal side effects 3, 5, 6
• The safety profile of Topical ALA has been established, with few significant adverse events reported 5, 7
• Local skin reactions, such as erythema and crusting, have been observed, but are generally mild and temporary 5