Safety of LEO 43204 for Actinic Keratosis Applied on Face/Chest, Scalp and Trunk/Extremities, Respectively
| Status: | Completed |
|---|---|
| Conditions: | Dermatology |
| Therapuetic Areas: | Dermatology / Plastic Surgery |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/4/2019 |
| Start Date: | March 2015 |
| End Date: | August 2015 |
Safety of LEO 43204 0.018%, 0.037% and 0.1% for Actinic Keratosis Applied Once Daily for Three Consecutive Days on Face/Chest, Scalp and Trunk/Extremities, Respectively
The objective of the trial is to investigate the Safety of LEO 43204 0.018%, 0.037% and 0.1%
for actinic keratosis applied once daily for three consecutive days on face/chest, scalp and
trunk/extremities, respectively.
for actinic keratosis applied once daily for three consecutive days on face/chest, scalp and
trunk/extremities, respectively.
Inclusion Criteria:
Subjects with 5 to 20 clinically typical, visible and, discrete, nonhyperkeratotic and
non-hypertrophic AKs within a selected treatment area of sun-damaged skin on either:
- The full face
- The full balding scalp
- A contiguous area of approximately 250 cm2 on trunk or extremities
Exclusion Criteria:
Location of the treatment area (full face, full balding scalp or chest) within 5 cm of an
incompletely healed wound or within 5 cm of a suspected basal cell carcinoma (BCC) or SCC.
Previously assigned treatment in this clinical trial or previously participated in a
clinical trial in the LEO 43204 programme.
Treatment with ingenol mebutate gel in the selected treatment area within the last 12
months
Lesions in the treatment area that have: atypical clinical appearance (e.g. cutaneous
horns) and/or, recalcitrant disease (e.g., did not respond to cryotherapy on two previous
occasions).
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