Aminoleban (Aminolevulinic Acid) Indications
Aminolevulinic acid (ALA) is FDA-approved for the treatment of actinic keratoses on the face and scalp, and is also indicated for superficial basal cell carcinomas, squamous cell carcinoma in situ (Bowen's disease), and selected cases of acne vulgaris when used with photodynamic therapy. 1
FDA-Approved Indications
Actinic Keratoses (Primary Indication)
- ALA 10% gel (AMELUZ) is FDA-approved for treatment of mild to moderate actinic keratoses on the face and scalp when combined with red light photodynamic therapy. 1
- The treatment involves application for 3 hours followed by red light illumination at approximately 37 J/cm² using BF-RhodoLED or RhodoLED XL devices. 1
- Complete clearance rates of 77.1% have been demonstrated at 12 weeks post-treatment with ALA-PDT versus 16.6% with placebo. 2
- Longer application times (1-4 hours) are conditionally recommended over shorter durations (0.5 hours) to enhance complete clearance, with 4-hour application achieving 73.5% complete clearance versus 23.5% with 0.5-hour application. 2
Daylight PDT Protocol
- ALA-daylight PDT with 2-hour natural sunlight exposure is equally effective as conventional red light PDT (96-97% lesion reduction) but significantly less painful. 2
- Mean pain scores are 1.7 for daylight PDT versus 5.2 for conventional red light PDT on an 11-point scale. 2
Licensed Indications (Non-US Markets)
Non-Melanoma Skin Cancers
- Superficial basal cell carcinomas: ALA-PDT is effective with good cosmetic outcomes, particularly where size, site, or number of lesions limit conventional therapy. 2
- Squamous cell carcinoma in situ (Bowen's disease): Methyl aminolevulinate (MAL) formulations are licensed for this indication in multiple countries. 2
- Nodular basal cell carcinomas: ALA-PDT alone is a relatively poor option; surgical excision remains preferred. 2
- Invasive squamous cell carcinomas: Limited evidence exists; ALA-PDT is not recommended as monotherapy. 2
Facial Cutaneous Squamous Cell Carcinoma In Situ
- ALA-PDT combined with pulsed dye laser achieved 94% histological clearance in facial lesions 0.4-1.3 cm in diameter (excluding skip lesions). 3
- This represents an off-label use with excellent cosmetic and functional results. 3
Emerging and Off-Label Indications
Acne Vulgaris
- ALA-PDT has demonstrated effectiveness in managing acne vulgaris, though this remains an off-label indication in most jurisdictions. 4, 5
- The treatment targets sebaceous glands and inflammatory acne lesions. 2
Other Dermatological Conditions (Limited Evidence)
- Viral warts, psoriasis, and cutaneous T-cell lymphoma show potential benefit but experience remains limited. 2
- These applications require further clinical validation before routine recommendation. 2
Important Clinical Considerations
Treatment Selection Algorithm
- First-line for actinic keratoses: Non-hyperkeratotic lesions on face/scalp in patients where cosmesis is important or multiple lesions require simultaneous treatment. 2
- Consider for superficial BCCs: When surgical excision would result in poor cosmetic outcome or treatment-related morbidity. 2
- Avoid for nodular BCCs and invasive SCCs: Surgical excision provides superior outcomes with histologic confirmation. 2
Key Advantages
- Minimal or no scarring with excellent cosmetic outcomes. 2
- Non-invasive with ability to treat multiple lesions simultaneously. 2
- Repeatable treatments possible without cumulative toxicity. 2
- Low carcinogenic risk profile. 2
Critical Limitations
- No histologic confirmation of complete tumor removal, unlike surgical excision—a major disadvantage for malignancies. 6
- Pain during illumination is the most frequent limiting side effect, particularly with head/face treatments and when using ALA versus MAL. 7
- Treatment of hyperkeratotic lesions requires pre-treatment preparation (curettage or keratolytics). 2