A Study to Evaluate Skin Irritation and Photo Irritation of JNJ 10229570-AAA on Intact Skin of Japanese Healthy Male Participants
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

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.
    

Intervention name(s): 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
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): 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.; 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.; 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.; 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.; 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.
Intervention MeSH terms: Petrolatum
Intervention model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Keywords: Healthy volunteers; JNJ 10229570-AAA; Skin irritation; Skin photo irritation