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A Study to Evaluate Skin Irritation and Photo Irritation of JNJ 10229570-AAA on Intact Skin of Japanese Healthy Male Subjects
The purpose of this study is to evaluate skin irritation and photo irritation of JNJ 10229570-AAA on intact skin of Japanese healthy male participants.
Details
| Lead sponsor | Janssen Pharmaceutical K.K. |
|---|---|
| Phase | Phase 1 |
| Status | COMPLETED |
| Enrolment | 30 |
| Start date | 2011-08 |
| Completion | 2011-09 |
Conditions
- Healthy Volunteers
Interventions
- JNJ 10229570-AAA 1.2% cream
- JNJ 10229570-AAA 2.4% cream
- JNJ 10229570-AAA 3.6% cream
- Color-matched vehicle in a cream formulation containing 0 mg of JNJ 10229570-AAA
- Petroleum jelly
Primary outcomes
- Skin irritation according to the Japanese evaluation criteria (scores on a scale) — 72 hours
The Japanese skin irritation evaluation criteria is a 6-point scale specifying the irritation level of the skin, from 0 (no response) to 4 (blister) - Skin photo irritation according to the Japanese evaluation criteria (scores on a scale) — 72 hours
The Japanese skin photo irritation evaluation criteria is a 6-point scale specifying the level of skin photo irritation from 0 (lack of reaction or reaction comparable to non-irradiated site) to 4 (reaction four ranks more pronouced using domestic criteria compared with non-irradiated site)
Countries
Japan