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PK Study of Levulan Kerastick in Actinic Keratosis
NCT02628236Phase 2
Key facts
- Status
- Completed
- Start
- Feb 2016
- Primary completion
- May 2016
- Countries
- 1
- Sponsor
- DUSA Pharmaceuticals
- Modality
- Small Molecules
- Conditions
- actinic keratosis (AK)
01
Overview
Phase 2, open-label, single-arm trial of 5-aminolevulinic acid in actinic keratosis (AK), sponsored by DUSA Pharmaceuticals. Primary endpoints: Maximum Baseline Corrected Plasma Concentration for ALA at 2 days, Time at Which Cmax is Attained for ALA at 2 days and 7 more. Started Feb 2016; status: completed.
02
Design
1 arm- Study design
- Non-randomizedOpen-label
ALA
20% aminolevulinic acid applied via Kerastick + BLU-U
03
Who it enrols
Patients with at least 6 Grade 1/2 AKs on one upper extremity and 12 on the other, excluding those with BMI > 32, immunosuppression, or recent use of interfering topical treatments.
04
Endpoints
Primary
Maximum Baseline Corrected Plasma Concentration for ALA
Time at Which Cmax is Attained for ALA
Area Under the Curve to the last measurable concentration for ALA
Terminal Exponential Half-life for ALA
Maximum Baseline Corrected Plasma Concentration for PpIX
Secondary
Hyperpigmentation
Hypopigmentation
Erythema
Edema
Stinging/Burning
Scaling and Dryness
Oozing/Vesiculation/Crusting
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