Phase 2
Completed N=14
Maximal Use Systemic Exposure Study of Levulan Kerastick (MUSE 2)
Keratosis, Actinic
Source: ClinicalTrials.gov NCT02628236 ↗
Enrolled (actual)
14
Serious AEs
7.1%
Results posted
Sep 2017
Primary outcomePrimary: Maximum Baseline Corrected Plasma Concentration (Cmax) for ALA — 39.05 ng/mL
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximum Baseline Corrected Plasma Concentration (Cmax) for ALA |
39.05 | — |
| PRIMARY Time at Which Cmax is Attained (Tmax) for ALA |
2 | — |
| PRIMARY AUCt |
182.1 | — |
| PRIMARY The Terminal Exponential Half-life (T1/2,z) for ALA |
5.386 | — |
| PRIMARY Maximum Baseline Corrected Plasma Concentration (Cmax) for PpIX |
0.735 | — |
| PRIMARY Time at Which Cmax is Attained (Tmax) for PpIX |
12 | — |
| PRIMARY AUCBL for PpIX |
77.34 | — |
| PRIMARY AUCt for PpIX |
77.00 | — |
| PRIMARY AUCt/AUCBL for PpIX |
0.9956 | — |
| SECONDARY Hyperpigmentation |
7; 6; 1; 0; 0 | — |
| SECONDARY Hypopigmentation |
8; 6; 0; 0; 0 | — |
| SECONDARY Erythema |
7; 6; 1; 0; 0 | — |
| SECONDARY Edema |
14; 0; 0; 0; 0 | — |
| SECONDARY Stinging/Burning |
13; 1; 0; 0 | — |
| SECONDARY Scaling and Dryness |
9; 5; 0; 0; 0 | — |
| SECONDARY Scaling and Dryness at Visit 4 |
9; 3; 1; 1; 0 | — |
| SECONDARY OOZING/VESICULATION/CRUSTING |
14; 0; 0; 0; 0 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02628236). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.