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Japanese Phase 1 Study of GSK2585823 (JPN P1)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01428466
First received: June 16, 2011
Last updated: August 1, 2013
Last verified: July 2013
  Purpose

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.


Condition Intervention Phase
Acne Vulgaris
Drug: GSK2585823
Drug: Benzoyl peroxide 3%
Drug: Benzoyl peroxide 5%
Other: Vehicle
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: Dermal Safety Study of GSK2585823 (Clindamycin 1%-Benzoyl Peroxide 3% Gel) With Healthy Japanese Male and Female Subjects

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Dermal irritancy (simple patch test) [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 22 days. ] [ Designated as safety issue: Yes ]
  • Photo allergy and toxicity (Photo patch test) [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 22 days. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Photo-toxicity and photo-allergy potential (photo-patch test) [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 22 days. ] [ Designated as safety issue: Yes ]
  • Safety and tolerability endpoints: adverse events, blood pressure, heart rate, 12-lead ECG, clinical laboratory safety tests [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 22 days. ] [ Designated as safety issue: Yes ]

Enrollment: 20
Study Start Date: November 2010
Study Completion Date: March 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: GSK2585823
external preparation
Drug: GSK2585823
CLDM1%/BPO3%
Active Comparator: Benzoic peroxide 3%
external preparation
Drug: Benzoyl peroxide 3%
Benzoyl peroxide 3%
Active Comparator: Benzoic peroxide 5%
external preparation
Drug: Benzoyl peroxide 5%
Benzoyl peroxide 5%
Placebo Comparator: Vehicle
external preparation
Other: Vehicle
placebo

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   20 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Healthy as determined by a responsible and experienced physician.
  2. Japanese healthy male and female subjects aged between 20 and 45 years of age inclusive, at the time of signing the informed consent.
  3. Asparate aminotransferase(AST), Alanine aminotransferase(ALT) and total bilirubin < Upper level of normal range
  4. Non-smoker (never smoked or not smoking for >6 months with <10 pack years history (Pack years = (cigarettes per day smoked/20) x number of years smoked)).
  5. Body Mass Index (BMI) within the range =>18.5 to < 25.0 kg/m2 at screening
  6. A female subject is eligible to participate if she is of:

    • Non-childbearing potential.
    • Child-bearing potential and agrees to use one of the contraception methods from screening to the follow up examination.
  7. Capable of giving written informed consent.
  8. Single QTcB < 450 msec at screening

Exclusion Criteria:

  1. A positive test for syphilis, Hepatitis B surface antigen or positive Hepatitis C antibody, HIV antibody and HTLV-1 result at screening.
  2. A positive for urine drug screening.
  3. History of regular alcohol consumption within 6 months of the study defined as:

    -an average weekly intake of >14 drinks for males or >7 drinks for females. One drink is equivalent to 12 g of alcohol: 350 mL of beer, 5 ounces (150 mL) of wine or 1.5 ounces (45 mL) of 80 proof distilled spirits.

  4. The subject has participated in a clinical study with an investigational or a non-investigational drug or device during the previous 4 months.
  5. The subject planned to concurrently participate in another clinical study or post-marketing study.
  6. Use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements (including St John's Wort) within 7 days prior to the first application of study medication, unless in the opinion of the Investigator and GSK Medical Monitor the medication will not interfere with the study procedures or compromise subject safety.
  7. History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the investigator or GSK Medical Monitor, contraindicates their participation.
  8. The subject has donated a unit of blood ">400 mL" within the previous 4 months or ">200 mL" within the previous 1 month.
  9. Pregnant females as determined by positive urine hCG test at screening or prior to dosing.
  10. Lactating females.
  11. Unwillingness or inability to follow the procedures outlined in the protocol.
  12. Subject is mentally or legally incapacitated.
  13. Subjects with clinically significant skin diseases which may contraindicate participation, or interfere with test site evaluations, including psoriasis, eczema, atopic dermatitis, acne, dysplastic nevi, or other skin pathologies.
  14. Subjects with a history of hypersensitivity or idiosyncratic reaction to benzoyl peroxide, clindamycin, lincomycin or any study medication components or requiring significant concomitant medications or with diseases affecting evaluation of study medication
  15. Subjects with scars, moles, other blemishes or tattoos, darkened skin or excessive hair on the utilised area of the mid or upper back which would interfere with grading the test sites
  16. Within six months (oral) or 2 weeks (topical) prior to and during the study, subjects must not be treated with retinoids.
  17. For one month (systemic) or 2 weeks (topical) before and during the study, subjects not to be treated with corticosteroids or any other medication that could interfere with study results.
  18. Subjects with sunburn or suntan on test area of mid or upper back
  19. Subjects with considerable exposure to sunlight, including sunlamps, on test area of mid or upper back
  20. Subjects with inherent sensitivity to sun or history of photosensitivity
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01428466

Locations
Japan
GSK Investigational Site
Tokyo, Japan, 170-0003
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01428466     History of Changes
Other Study ID Numbers: 114849
Study First Received: June 16, 2011
Last Updated: August 1, 2013
Health Authority: Japan: Ministry of Health, Labor and Welfare

Additional relevant MeSH terms:
Acne Vulgaris
Acneiform Eruptions
Facial Dermatoses
Sebaceous Gland Diseases
Skin Diseases
Benzoyl Peroxide
Dermatologic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014