Trials / Completed
CompletedNCT02628236
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
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 14 (actual)
- Sponsor
- DUSA Pharmaceuticals, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Aminolevulinic Acid (ALA) | 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light |
| DEVICE | BLU-U | 10 J/cm2 of 417 nm blue light delivered at 10 mW/cm2 |
Timeline
- Start date
- 2016-02-01
- Primary completion
- 2016-05-01
- Completion
- 2016-07-01
- First posted
- 2015-12-11
- Last updated
- 2017-09-18
- Results posted
- 2017-09-18
Locations
2 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT02628236. Inclusion in this directory is not an endorsement.