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Levulan® Kerastick®
Levulan (aminolevulinic acid) is a photosensitizing agent that accumulates in skin lesions and generates reactive oxygen species when activated by blue light, destroying abnormal cells.
Levulan (aminolevulinic acid) is a photosensitizing agent that accumulates in skin lesions and generates reactive oxygen species when activated by blue light, destroying abnormal cells. Used for Actinic keratosis (non-hyperkeratotic, non-hypertrophic lesions on face and scalp), Actinic keratosis (hyperkeratotic and hypertrophic lesions on face and scalp) when used with occlusion.
At a glance
| Generic name | Levulan® Kerastick® |
|---|---|
| Also known as | Intervention Group |
| Sponsor | Medical Dermatology Specialists |
| Drug class | Photosensitizing agent |
| Target | Protoporphyrin IX (photodynamic therapy precursor) |
| Modality | Small molecule |
| Therapeutic area | Dermatology |
| Phase | FDA-approved |
Mechanism of action
Aminolevulinic acid (ALA) is a naturally occurring precursor to protoporphyrin IX, which accumulates preferentially in dysplastic and neoplastic cells. When the skin is exposed to blue light (417 nm wavelength) after ALA application, protoporphyrin IX is activated to produce singlet oxygen and free radicals that cause selective photodynamic destruction of target lesions. This mechanism allows targeted destruction of actinic keratosis and other skin lesions with minimal damage to surrounding normal tissue.
Approved indications
- Actinic keratosis (non-hyperkeratotic, non-hypertrophic lesions on face and scalp)
- Actinic keratosis (hyperkeratotic and hypertrophic lesions on face and scalp) when used with occlusion
Common side effects
- Erythema
- Edema
- Burning/stinging sensation
- Crusting
- Photosensitivity
Key clinical trials
- Study of Reformulated Levulan Kerastick Plus PDT for Actinic Keratosis on Face and Scalp (PHASE3)
- Study of Reformulated Levulan Kerastick Plus PDT for Actinic Keratosis on Upper Extremities (PHASE3)
- Photodynamic Therapy for Benign Dermal Neurofibromas- Phase II (PHASE2)
- Evaluating the Use of Photodynamic Therapy to Treat Facial Cutaneous Squamous Cell Carcinoma in Situ (isSCC) (PHASE2)
- Photodynamic Therapy Incubation Times for Actinic Keratosis (NA)
- DUSA: Cyclic PDT for the Prevention of AK & NMSC in Solid Organ Transplant Recipients (PHASE1, PHASE2)
- Protocols for Painless Photodynamic Therapy (PDT) of Actinic Keratoses (PHASE3)
- Comparison of Two Modes of Photodynamic Therapy for the Treatment of Actinic Keratosis on the Upper Extremities (PHASE4)
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:
- Levulan® Kerastick® CI brief — competitive landscape report
- Levulan® Kerastick® updates RSS · CI watch RSS
- Medical Dermatology Specialists portfolio CI