NCT01494714

A Study to Evaluate Skin Irritation and Photo Irritation of JNJ 10229570-AAA on Intact Skin of Japanese Healthy Male Participants

A Study to Evaluate Skin Irritation and Photo Irritation of JNJ 10229570-AAA on Intact Skin of Japanese Healthy Male Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Janssen Pharmaceutical K.K. · Industry
• Sex: Male
• Age: 20 Years – 40 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

This is a single center, interpreter-blinded (the person interpreting the results does not know the name of the assigned drug), randomized (drug is assigned by chance like flipping a coin), vehicle-controlled, closed-patch test study. Thirty (30) Japanese participants will be enrolled in the study. Each treatment (JNJ 10229570-AAA at 1.2%, 2.4%, 3.6%, vehicle in a cream formulation, and petroleum jelly) will be randomly applied in vertical position on the back of each participant, with a corresponding strength applied at the same vertical position (left vs. right). The study drugs applied on the left side will be washed off at 48 hours after application. The dermatological evaluation and photo shoots will be done at 1 (T49) and 24 (T72) hours after washing off the drugs. All participants who completed the dermatological evaluation will be included in the evaluation of skin irritation and skin photo irritation. The study drugs applied on the right side will be washed off at 24 hours after application. The dermatological evaluation and photo shoots will be done at 1 hour after washing off. Ultraviolet A (UVA) will be irradiated to the application site. One hour after irradiation start (T26), the dermatological evaluation and photo shoots will be done. Afterwards the application site will be covered for the protection against UV. Twenty-four hours after washing off (T48), the cover will be taken off, and then the dermatological evaluation and photo shoots will be done at 1 (T49) and 24 (T72) hours. Additionally, the safety profile of JNJ 10229570-AAA will be assessed during the study. The study has a total duration of maximum 32 days.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	JNJ 10229570-AAA 1.2% cream	A patch containing the cream will be applied on the back and left for 48 hours on the left side, and 24 hours on the right side.
DRUG	JNJ 10229570-AAA 2.4% cream	A patch containing the cream will be applied on the back and left for 48 hours on the left side, and 24 hours on the right side.
DRUG	JNJ 10229570-AAA 3.6% cream	A patch containing the cream will be applied on the back and left for 48 hours on the left side, and 24 hours on the right side.
DRUG	Color-matched vehicle in a cream formulation containing 0 mg of JNJ 10229570-AAA	A patch containing the cream will be applied on the back and left for 48 hours on the left side, and 24 hours on the right side.
DRUG	Petroleum jelly	A patch containing the petroleum jelly will be applied on the back and left for 48 hours on the left side, and 24 hours on the right side.

Timeline

• Start date: 2011-08-01
• Primary completion: 2011-09-01
• Completion: 2011-09-01
• First posted: 2011-12-19
• Last updated: 2012-10-31

Locations

2 sites across 1 country: Japan