Japanese Phase 1 Study of GSK2585823
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a randomized, single-center, partial-blind study to evaluate the dermal irritation
      potential and to detect photo-toxicity and photo-allergy potential of GSK2585823, Benzoyl
      peroxide BPO 5% gel, Benzoyl peroxide 3% gel, vehicle gel and negative control (distilled
      water) applied using Finn-Chambers® by single and 7-day repeat patch test in 20 Japanese
      healthy male and female volunteers. Finn-Chambers containing no investigational product will
      be applied in the same manner.

      Safety will also be assessed by measurement of vital signs, electrocardiograms, safety
      laboratory data and review of adverse events.
    

Detailed description: 
      Each subjects will be applied the adequate amount of GSK2585823, Benzoyl peroxide 3%, Benzoyl
      peroxide 5%, placebo (Vehicle) and negative control (distilled water) using Finn Chambers on
      Scanpor (the tape for the patch test which Finn Chamber® put on the Scanpor® tape in advance)
      on their upper back at same time for the simple patch test and the photo patch test. The
      empty Finn Chamber® will also be applied at the same time. The position of application for
      each product (including empty Finn Chamber®) will be randomized The position of application
      for each subjects will be same for the simple patch test and the photo patch test.

      For the simple patch test, dermal condition will be assessed up to 48 hours after removal of
      the Finn-Chambers®. After removing the Finn-Chambers®, the skin areas will be gently wiped
      with wet absorbent cotton before the first evaluation at 30 minutes.

      For the photo patch test, two sets of Finn-Chambers® will be applied to the skin. Twenty-four
      hours after the single application or the last application of the repeat dosing, a set of
      Finn-Chambers® will be removed. The skin areas will be gently wiped and exposed to 6.0 J/cm2
      of ultraviolet A. The other set of Finn-Chambers® are covered to avoid ultraviolet A exposure
      to serve as un-irradiated control when photo-allergy is assessed 30 minutes after ultraviolet
      A exposure. After the assessment, the skin areas will be covered with empty Finn-Chambers®
      for additional 24 hours to prevent further exposure to light. Photo-toxicity will be assessed
      24 and 48 hours after the ultraviolet A exposure.

      Assessment of Simple Patch test

        1. The dermatologist will examine the planned application sites and skin reactions at the
           application sites, and make assessments at the following time points according to the
           criteria proposed by the patch test study group in Japan.

           <Single application phase> Day 1: just before application Day 3: 30 minutes after
           removal of study medication (48.5 hours after application) Day 4: 24 hours after removal
           of study medication (72 hours after application) <Repeat application phase> Day 5: just
           before application Days 6-11: every 24 hours (30 minutes after removal; about 23.5 hours
           after application). This result will be used only for safety assessment and not for
           calculation of irritation index.

           Day 12: 30 minutes after removal of last study medication (24.5 hours after the last
           application) Day 13: 24 hours after removal of last study medication (48 hours after the
           last application) Day 14: 48 hours after removal of last study medication (72 hours
           after the last application)

           Assessment Criteria Proposed by Patch Test Study Group in Japan No visible reaction(-);
           0 Minimal visible erythema(±); 0.5 Erythema(+); 1 Erythema + edema(++); 2 Erythema +
           edema + papules + vesicles(+++); 3 Erythema bullosum (++++); 4

        2. The dermatologist will examine that application site on Day 4 for single application
           phase and Day 14 for repeat application phase to determine whether the symptom is an
           allergic reaction or not.

      Assessment of Photo Patch Test

        1. The scorer (dermatologist) will examine the planned application sites and skin reactions
           at the application sites, and make assessments at the following time points according to
           the criteria proposed by the patch test study group of Japan Dermatology Society].

           <Single application phase> Day 1: just before application Day 3: 24 hours after
           irradiation (48 hours after application) Day 4: 48 hours after irradiation (72 hours
           after application) <Repeat application phase> Day 5: just before application Day 13: 24
           hours after removal of last study medication (48 hours after the last application) Day
           14: 48 hours after removal of last study medication (72 hours after the last
           application)

        2. The dermatologist will examine the irradiation sites 30 minutes after irradiation (about
           24.5 hours after the start of application) on Day 2 (single) and to determine whether
           there is photo-urticaria or not.

        3. 30 minutes after irradiation to determine whether there is photo-urticaria or not. Then,
           24 and 48 hours after irradiation, the skin reactions at the irradiation sites will be
           compared with the corresponding non-irradiation site for photo patch test, using the
           criteria showing in Table 1 and the photo-toxicity of each investigational product will
           be assessed according to the following criteria.

      Assessment Criteria for Photo-toxicity No reaction or similar to the non irradiation site; -
      Slightly stronger than the non irradiation site; ± Definitely stronger than the non
      irradiation site; + 2 ranks stronger than the non irradiation site according to the criteria
      in Japan; ++ 3 ranks stronger than the non irradiation site according to the criteria in
      Japan; +++
    

Intervention name(s): GSK2585823; Benzoyl peroxide 3%; Benzoyl peroxide 5%; Vehicle
Intervention type(s): Drug; Drug; Drug; Other
Intervention description(s): CLDM1%/BPO3%; Benzoyl peroxide 3%; Benzoyl peroxide 5%; placebo
Intervention MeSH terms: Benzoyl Peroxide
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Prevention