Efficacy and Safety of Ingenol Mebutate Gel 0.06% When Applied Once Daily for 2, 3 or 4 Consecutive Days to a Treatment Area of Approximately 250 cm2 on Trunk and Extremities in Subjects With Actinic Keratosis
| Status: | Completed |
|---|---|
| Conditions: | Dermatology |
| Therapuetic Areas: | Dermatology / Plastic Surgery |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 12/9/2018 |
| Start Date: | January 2014 |
| End Date: | July 2014 |
This is a randomised, double-blind, parallel groups, vehicle controlled, 8-week phase 2
trial. The objective is to evaluate efficacy of ingenol mebutate gel 0.06 % after once daily
treatment for 2, 3 or 4 consecutive days compared to vehicle gel
trial. The objective is to evaluate efficacy of ingenol mebutate gel 0.06 % after once daily
treatment for 2, 3 or 4 consecutive days compared to vehicle gel
Inclusion Criteria:
Subjects with 5 to 20 clinically typical, visible and discrete AKs within a contiguous area
of approximately 250 cm² sun-damaged skin on either trunk (except chest), or extremities
Exclusion Criteria:
- Location of the treatment area (trunk (except chest) or extremities)
- within 5 cm of an incompletely healed wound,
- within 5 cm of a suspected basal cell carcinoma (BCC) or squamous cell carcinoma
(SCC)
- Prior treatment with ingenol mebutate within the selected treatment area
- Lesions in the treatment area that have:
- atypical clinical appearance (e.g., hypertrophic,hyperkeratotic or cutaneous
horns) and/or,
- recalcitrant disease (e.g., did not respond to cryotherapy on two previous
occasions)
We found this trial at
1
site
Click here to add this to my saved trials
