At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 14 enrolled
Drug / intervention
Aminolevulinic Acid (ALA) +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Pharmacokinetic Study of Levulan Kerastick (Aminolevulinic Acid HCl) for Topical Solution, 20% Under Maximal Use Conditions
In Brief
A Phase 2 clinical trial evaluating Aminolevulinic Acid (ALA) and BLU-U for Keratosis, Actinic. Completed, enrolled 14 participants across 2 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsKeratosis, Actinic
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedDec 2015
Enrollment StartFeb 2016
Primary CompletionMay 2016
Study CompletionJul 2016
TodayJul 2026
First PostedDec 11, 2015
Enrollment StartFeb 1, 2016
Primary CompletionMay 1, 2016
Study CompletionJul 1, 2016
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 10.6 years ago
Interventions
Aminolevulinic Acid (ALA)drug
20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light
BLU-Udevice
10 J/cm2 of 417 nm blue light delivered at 10 mW/cm2