Safety and Efficacy of Doses of LEO 43204 Once Daily for Two Consecutive Days on Full Balding Scalp in Subjects With Actinic Keratosis
| Status: | Completed |
|---|---|
| Conditions: | Dermatology |
| Therapuetic Areas: | Dermatology / Plastic Surgery |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 2/20/2019 |
| Start Date: | May 2014 |
| End Date: | March 2015 |
Safety and Efficacy of Escalating Doses of LEO 43204 Applied Once Daily for Two Consecutive Days on Full Balding Scalp in Subjects With Actinic Keratosis
To identify the Maximum Tolerated Dose levels of LEO 43204 after once daily treatment for two
consecutive days and to evaluate efficacy of LEO 43204 in two doses after once daily
treatment for two consecutive days compared to vehicle
consecutive days and to evaluate efficacy of LEO 43204 in two doses after once daily
treatment for two consecutive days compared to vehicle
Inclusion Criteria:
- Part 1: Subjects with 5 to 20 clinically typical, visible and discrete AKs on the full
balding scalp.
- Part 2: Subjects with 5 to 20 clinically typical, visible and discrete AKs on the full
balding scalp
Exclusion Criteria:
- Location of the treatment area
- 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 gel on the treatment area
- Lesions in the treatment areas 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
