Last reviewed · How we verify
A Pilot Prospective Clinical Trial to Evaluate the Efficacy and Safety of Large-Scale, Field-Directed Topical Therapy of Actinic Keratosis of the Chest With Ingenol Mebutate 0.015%
Evaluate the Efficacy and Safety of Large-Scale Field-Directed Topical Therapy of Actinic Keratosis of the Chest w/Ingenol Mebutate 0.015%
Details
| Lead sponsor | Goldman, Butterwick, Fitzpatrick and Groff |
|---|---|
| Phase | Phase 4 |
| Status | COMPLETED |
| Enrolment | 21 |
| Start date | 2015-01 |
| Completion | 2016-09 |
Conditions
- Actinic Keratosis
Interventions
- Inggenol Mebutate 0.015%
Primary outcomes
- Change in Lesion Count From Baseline to Day 59 — Day 59
The primary efficacy endpoint will be complete clearance of all clinically visible AKs and no development of any new AKs on day 59. Lesion clearance will be determined on day 59 (visit 7) by comparing pretreatment lesion count with current lesion count on day 59, with primary efficacy endpoint being clearance of all lesions in treatment field and no growth of new lesions.
Countries
United States