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Phase 3 Study of Brand Generic and Placebo in Treatment of Actinic Keratosis
This is a double-blind, randomized, placebo-controlled, three treatment parallel study in which normal, healthy men and women (age 45-85) with actinic keratosis will be treated on the face once daily for two weeks with 5-Fluorouracil Cream 0.5%, Spear Pharmaceuticals (Generic), Carac® Cream 0.5% (Brand), or Cream Vehicle (Placebo). Actinic keratoses will be counted at the baseline visit and at the visit four weeks following cessation of treatment.
Details
| Lead sponsor | Spear Pharmaceuticals |
|---|---|
| Phase | Phase 3 |
| Status | COMPLETED |
| Enrolment | 377 |
| Start date | 2010-09 |
| Completion | 2011-03 |
Conditions
- Actinic Keratoses
Interventions
- Brand Carac
- Generic 0.5% 5-fluorouracil cream
- Placebo cream
Primary outcomes
- Percent of patients with clearing — August 28, 2010 to March 17, 2011
- Clearing of actinic keratosis — 42 days