At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 266 enrolled
Drug / intervention
aminolevulinic acid HCL (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 Randomized, Evaluator-blinded, Parallel Group Light Dose Ranging Study of Photodynamic Therapy With Levulan Topical Solution + Blue Light Versus Levulan Topical Solution Vehicle + Blue Light on Moderate to Severe Facial Acne Vulgaris
In Brief
A Phase 2 clinical trial evaluating aminolevulinic acid HCL (ALA) and Vehicle (VEH) for Acne Vulgaris. Completed, enrolled 266 participants across 14 sites.
Detailed Summary
The purpose of this study is to determine and compare the safety and efficacy of multiple broad area photodynamic therapy treatments with aminolevulinic acid (ALA-PDT) and vehicle (VEH-PDT) in subjects with moderate to severe facial acne vulgaris.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcne Vulgaris
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartMar 2007
First PostedJun 2008
Primary CompletionJul 2008
TodayJul 2026
First PostedJun 27, 2008
Enrollment StartMar 1, 2007
Primary CompletionJul 1, 2008
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 18.0 years ago
Interventions
aminolevulinic acid HCL (ALA)drug
Levulan Kerastick containing 20% aminolevulinic acid HCL (ALA). Up to 4 treatments will be given at 3 week intervals.
Vehicle (VEH)other
Levulan Kerastick containing vehicle ingredients only (VEH). Up to 4 treatments will be given at 3 week intervals.