Ignite Creation Date:
2025-12-24 @ 4:34 PM
Ignite Modification Date:
2025-12-28 @ 11:41 AM
Study NCT ID:
NCT01428466
Status:
COMPLETED
Last Update Posted:
2017-08-04
First Post:
2011-06-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Japanese Phase 1 Study of GSK2585823
Sponsor:
GlaxoSmithKline
Organization:
Study Overview
Official Title:
Dermal Safety Study of GSK2585823 (Clindamycin 1%-Benzoyl Peroxide 3% Gel) With Healthy Japanese Male and Female Subjects
Status:
COMPLETED
Status Verified Date:
2017-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
JPN P1
Brief 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.
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; +++
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; +++
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: