Clinical trial · Interventional
Phase 3 Study of Levulan With New Blue Light for AK on the Face or Scalp
A RANDOMIZED, VEHICLE-CONTROLLED PHASE 3 STUDY TO PROVE THE SAFETY AND EFFICACY OF LEVULAN KERASTICK (AMINOLEVULINIC ACID HCl) FOR TOPICAL SOLUTION, 20% AND 10 J/CM2 OF BLUE LIGHT DELIVERED AT 10 MW/CM2 OR 20 MW/CM2 BY A NEW LIGHT SOURCE FOR THE TREATMENT OF ACTINIC KERATOSES ON THE FACE OR SCALP
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Study withdrawn due to corporate business decision
Summary
Brief summary (as posted)
The purpose of this study is to prove the safety and efficacy of Levulan Kerastick (aminolevulinic acid HCl) for Topical Solution 20% followed by 10 J/cm2 of blue light delivered at 10 mW/cm2 or 20 mW/cm2 in the treatment of multiple actinic keratosis on the face or balding scalp (the Treatment Area), utilizing a 14-18 hour incubation period.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Actinic Keratosis | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ALA | Drug | — | UNRESOLVED |
| IBL 10 mW | Device | — | UNRESOLVED |
| IBL 20 mW | Device | — | UNRESOLVED |
| Vehicle | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- ALA 20 mW
- description
- ALA + IBL 10J at 20 mW (8min 20 sec)
- interventionNames
- Drug: ALA
- Device: IBL 20 mW
- type
- EXPERIMENTAL
- label
- ALA 10 mW
- description
- ALA + IBL 10J at 10 mW (16 min 40 sec)
- interventionNames
- Drug: ALA
- Device: IBL 10 mW
- type
- PLACEBO_COMPARATOR
- label
- Vehicle
- description
- Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving light treatment delivered at 20 mW/cm2 OR 10 mW/cm2. Subjects receiving VEH will be considered a single treatment group
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Four to fifteen Grade 1/2 actinic keratosis lesions (AKs) on the face OR balding scalp Exclusion Criteria: * Pregnancy * grade 3 and/or atypical \>1cm AKs within Treatment Area and/or more than 15 AKs of any Grade within the Treatment Area * history of cutaneous photosensitization, porphyria, hypersensitivity to porphyrins or photodermatosis * lesions suspicious for skin cancer (skin cancer not ruled out by biopsy) or untreated skin cancers within the Treatment Area * skin pathology or condition which could interfere with the evaluation of the test product or requires the use of interfering topical or systemic therapy * Subject is immunosuppressed * unsuccessful outcome from previous ALA-PDT therapy * currently enrolled in an investigational drug or device study * has received an investigational drug or been treated with an investigational device within 30 days prior to the initiation of treatment * known sensitivity to one or more of the vehicle components (ethyl alcohol, isopropyl alcohol, laureth 4, polyethylene glycol) * has active herpes simplex infection in the Treatment Area OR a history of 2 or more outbreaks within past 12 months, in the Treatment Area * use of the following topical preparations on the extremity to be treated: * Keratolytics including urea (greater than 5%), alpha hydroxyacids \[e.g.glycolic acid, lactic acid, etc. greater than 5%\], salicylic acid (greater than 2%) within 2 days of initiation of treatment. * Curettage or Cryotherapy within 2 weeks of initiation of treatment * Retinoids, including tazarotene, adapalene, tretinoin, within 4 weeks of initiation of treatment. * Microdermabrasion, laser ablative treatments, ALA-PDT, chemical peels, 5-FU, diclofenac, ingenol mebutate, imiquimod or other topical treatments for AK within 8 weeks of initiation of treatment. * use of systemic retinoid therapy within 6 months of initiation of treatment.
References
Publications (0)
Data not yet available