Clinical trial · Interventional
Maximal Use Systemic Exposure Study of Levulan Kerastick (MUSE 2)
A Pharmacokinetic Study of Levulan Kerastick (Aminolevulinic Acid HCl) for Topical Solution, 20% Under Maximal Use Conditions
NCT02628236CI-TRIAL-00029572completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to evaluate the potential for systemic exposure of aminolevulinic acid (ALA) and protoporphyrin IX (PpIX) when applied topically under occlusion, in a maximal use setting in patients with multiple actinic keratoses (AK) involving the upper extremities.
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 |
|---|---|---|---|
| Keratosis, Actinic | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Aminolevulinic Acid (ALA) | Drug | Aminolevulinic Acid | ALIAS |
| BLU-U | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- ALA
- description
- 20% aminolevulinic acid applied via Kerastick to individual AK lesions on the upper extremities and covered with occlusive dressing for 3 hours prior to BLU-U treatment
- interventionNames
- Drug: Aminolevulinic Acid (ALA)
- Device: BLU-U
Primary outcomes (9)
- measure
- Maximum Baseline Corrected Plasma Concentration (Cmax) for ALA
- timeFrame
- 2 days
- description
- Maximum baseline corrected plasma concentration (Cmax) for ALA over the 24 hour sampling time period. Blood samples were taken before ALA application and at 15 and 30 minutes, 1, 2, 4, 8, 12, 16, 24, 36 and 48 hours following study medication application.
- measure
- Time at Which Cmax is Attained (Tmax) for ALA
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * At least 6 Grade 1/2 AKs on one upper extremity AND * At least 12 Grade 1/2 AKs on the OTHER upper extremity Exclusion Criteria: * Pregnancy * 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 * Body Mass Index (BMI) \> 32.0 kg/m2 * skin pathology or condition which could interfere with the evaluation of the test product or requires the use of interfering topical or systemic therapy * significant blood loss within 60 days or donated blood/plasma within 72 hours prior to Visit 2 (Baseline) * tested positive at screening for human immunodeficiency virus (HIV) or was known to be seropositive for HIV * a history of lead poisoning or a history of a significant exposure to lead * tested positive at screening for hepatitis B surface antigen, hepatitis C antibody or had a history of a positive result * positive drug screen at Screening * Screening safety labs are clinically significant in the opinion of the investigator * major surgery within 30 days prior to Visit 2 (Baseline) or plans to have surgery during the study * Subject is immunosuppressed * 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 Visit 2 (Baseline) * known sensitivity to one or more of the vehicle components (ethyl alcohol, isopropyl alcohol, laureth 4, polyethylene glycol) * use of the following topical preparations on the extremities 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 * Cryotherapy within 2 weeks of initiation of treatment * Retinoids, including tazarotene, adapalene, tretinoin, retinol, within 4 weeks of initiation of treatment * Microdermabrasion, laser ablative treatments, ALA-PDT, chemical peels, 5-FU, diclofenac, 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
No reference posted for this study.