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Ameluz 10% Topical Gel
Ameluz is a topical photodynamic therapy agent that generates reactive oxygen species upon light activation to destroy abnormal skin cells.
Ameluz is a topical photodynamic therapy agent that generates reactive oxygen species upon light activation to destroy abnormal skin cells. Used for Actinic keratosis (field treatment), Basal cell carcinoma (superficial and nodular).
At a glance
| Generic name | Ameluz 10% Topical Gel |
|---|---|
| Also known as | ALA gel |
| Sponsor | Psoriasis Treatment Center of Central New Jersey |
| Drug class | Photodynamic therapy agent |
| Target | Protoporphyrin IX (photosensitizer) |
| Modality | Small molecule |
| Therapeutic area | Dermatology/Oncology |
| Phase | FDA-approved |
Mechanism of action
Ameluz contains aminolevulinic acid (ALA), which is converted to protoporphyrin IX in skin cells. When exposed to red light (635 nm wavelength), protoporphyrin IX generates singlet oxygen and reactive oxygen species that selectively damage and destroy target cells. This mechanism is particularly effective against actinic keratosis and other precancerous skin lesions.
Approved indications
- Actinic keratosis (field treatment)
- Basal cell carcinoma (superficial and nodular)
Common side effects
- Erythema
- Edema
- Burning/pain at application site
- Crusting
- Photosensitivity
Key clinical trials
- Assessment of Skin Lesions Using a Tissue Oxygen Imager Based on Protoporphyrin IX (PPIX) Fluorescence. This is an Open-label, Non-randomized, Feasibility Study That Includes a One-time Application of an FDA Approved Medication Followed by Local Imaging for Benign Skin Growth and Lesions Clinically
- Short Contact Protocols to Reduce Pain During 10% ALA Gel Red-light Photodynamic Therapy of Actinic Keratoses (PHASE2)
- Cryotherapy in Combination with Red Light PDT for Actinic Keratosis of Full Face (PHASE4)
- Evaluating the Use of Photodynamic Therapy to Treat Facial Cutaneous Squamous Cell Carcinoma in Situ (SCCis) (PHASE2)
- Comparison of Two Modes of Photodynamic Therapy for the Treatment of Actinic Keratosis on the Upper Extremities (PHASE4)
- Study to Evaluate the Safety of BF-200 ALA (Ameluz®) for Photodynamic Therapy (PDT) in the Treatment of Expanded Fields of Actinic Keratosis (AK) (PHASE1)
- A Clinical Trial of Topical Photodynamic Therapy With 5-aminolevulinic Acid for the Treatment of Actinic Keratosis (PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Ameluz 10% Topical Gel CI brief — competitive landscape report
- Ameluz 10% Topical Gel updates RSS · CI watch RSS
- Psoriasis Treatment Center of Central New Jersey portfolio CI