Efficacy and Safety of LEO 43204 in the Field Treatment of Actinic Keratosis on Face or Chest including12-month Follow-up
| Status: | Completed |
|---|---|
| Conditions: | Dermatology |
| Therapuetic Areas: | Dermatology / Plastic Surgery |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 12/7/2018 |
| Start Date: | November 13, 2015 |
| End Date: | August 10, 2017 |
Efficacy and Safety of LEO 43204 in the Field Treatment of Actinic Keratosis on Face or Chest Including 12-month Follow-up
The objective of the trial is to compare the short term efficacy of LEO 43204 gel with
vehicle gel in AK on face or chest when applied topically once daily for 3 consecutive days
as field treatment
vehicle gel in AK on face or chest when applied topically once daily for 3 consecutive days
as field treatment
Inclusion Criteria:
- Subjects with 5 to 20 clinically typical, visible and discrete AKs within a treatment
area of sun-damaged skin on either the full face or a contiguous area of approximately
250 cm2 (40 in2) on the chest
- Subjects with minimum 3 clinically typical, visible and discrete AKs within a tracking
area of 50 cm2 (8 in2). The tracking area must be within the treatment area
Exclusion Criteria:
- Location of the treatment area (full face or chest) within 5 cm of an incompletely
healed wound or within 5 cm of a suspected BCC or SCC
- Treatment with ingenol mebutate gel in the treatment area within the last 12 months
- Lesions in the treatment area that have: atypical clinical appearance (e.g.
hyperthrophic, hyperkeratotic or cutaneous horns) and /or, recalcitrant disease (e.g.
did not respond to cryotherapy on two previous occasions)
- History or evidence of skin conditions other than the trial indication that would
interfere with the evaluation of the trial medication (e.g., eczema, unstable
psoriasis, xeroderma pigmentosum)
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