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Biological Effects of LEO 43204 in Actinic Keratosis Assessed by Histopathology
This is a Phase I, single-centre, open label, within-subject comparison trial to explore the biological effects of LEO 43204 Gel, 0.037%, applied once daily for 3 consecutive days in patients with actinic keratosis on the upper extremity. The treatment area for each patient will be as defined as a contiguous area of 250 cm2 of skin on the upper extremity (including the dorsum manus) that contains a minimum of 5 AK lesions. Additionally there must be at least one AK lesion located in a non-treated area on the contralateral arm. All eligible subjects will receive LEO 43204 Gel, 0.037%, on the treatment area on Days 1, 2 and 3. Study medication application will be (sub)investigator applied. A total of 30 patients will be enrolled into this study (n=15 in each of the two groups). Patients will be divided into two groups with different biopsy schedules.
Details
| Lead sponsor | LEO Pharma |
|---|---|
| Phase | Phase 1 |
| Status | COMPLETED |
| Enrolment | 24 |
| Start date | 2016-07 |
| Completion | 2017-01-16 |
Conditions
- Actinic Keratosis
Interventions
- LEO 43204 Gel, 0.037%
- LEO 43204 Gel, 0.037%
Primary outcomes
- Number of CD3+ T lymphocytes assessed by immunohistochemistry in biopsies from AK lesions 56 days after first treatment. — 56 days
Countries
United States