At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 422 enrolled
Drug / intervention
Generic Fluorouracil Cream +2 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 Multicenter, Randomized, Double-Blind, Vehicle-Controlled, Parallel Group Comparison Study to Determine the Therapeutic Equivalence of Generic Fluorouracil Cream, 0.5% and Carac® (Fluorouracil) Cream, 0.5% in Subjects With Actinic Keratoses
In Brief
A Phase 3 clinical trial evaluating Generic Fluorouracil Cream, Carac® (Fluorouracil) Cream, and 1 other intervention for Actinic Keratosis. Completed, enrolled 422 participants across 17 sites.
Detailed Summary
This study is to evaluate the efficacy and safety of a generic formulation of fluorouracil 0.5% cream against the brand product (Carac) in participants with actinic keratoses.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsActinic Keratosis
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
Enrollment StartFeb 2015
Primary CompletionSep 2015
First PostedNov 2015
TodayJul 2026
First PostedNov 30, 2015
Enrollment StartFeb 27, 2015
Primary CompletionSep 17, 2015
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 10.6 years ago
Interventions
Generic Fluorouracil Creamdrug
Topical cream, generic formulation of the brand product.
Carac® (Fluorouracil) Creamdrug
Topical cream, brand product.
Vehicle Creamdrug
Topical cream, placebo. Has no active ingredient.