At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 153 enrolled
Drug / intervention
Visonac PDT +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.
PCTA206/11 A Double Blinded, Prospective, Randomized, Vehicle Controlled Multi Center Study of Photodynamic Therapy With Visonac® Cream in Patients With Acne Vulgaris.
In Brief
A Phase 2 clinical trial evaluating Visonac PDT and Vehicle cream with PDT for Acne Vulgaris. Completed, enrolled 153 participants across 15 sites.
Detailed Summary
This study is intended to evaluate the efficacy and safety of Visonac Photodynamic Therapy (PDT) in patients with severe acne, score 4 on global IGA scale. The null hypothesis is that Visonac PDT is equal to vehicle PDT against the alternative hypothesis that Visonac PDT is different compared to vehicle PDT at week 12.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcne Vulgaris
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
Enrollment StartMay 2011
First PostedMay 2011
Primary CompletionApr 2012
Study CompletionMay 2012
TodayJul 2026
First PostedMay 4, 2011
Enrollment StartMay 1, 2011
Primary CompletionApr 1, 2012
Study CompletionMay 1, 2012
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 15.2 years ago
Interventions
Visonac PDTdrug
cream application prior to illumination with red light
Vehicle cream with PDTdrug
placebo/vehicle cream application prior to illumination with red light