Last updated: 11/07/2018 08:19:41
Japanese Phase 1 study of GSK2585823JPN P1
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: Dermal Safety Study of GSK2585823 (Clindamycin 1%-Benzoyl peroxide 3% gel) with Healthy Japanese Male and Female Subjects
Trial description: 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.
Primary purpose:
Prevention
Trial design:
Single Group Assignment
Masking:
Single (Participant)
Allocation:
Randomized
Primary outcomes:
Dermal irritancy (simple patch test)
Timeframe: Participants will be followed for the duration of hospital stay, an expected average of 22 days.
Photo allergy and toxicity (Photo patch test)
Timeframe: Participants will be followed for the duration of hospital stay, an expected average of 22 days.
Secondary outcomes:
Photo-toxicity and photo-allergy potential (photo-patch test)
Timeframe: Participants will be followed for the duration of hospital stay, an expected average of 22 days.
Safety and tolerability endpoints: adverse events, blood pressure, heart rate, 12-lead ECG, clinical laboratory safety tests
Timeframe: Participants will be followed for the duration of hospital stay, an expected average of 22 days.
Interventions:
Enrollment:
20
Primary completion date:
Not applicable
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Nakahara N, Nohda S, Hirama T. Dermal safety of GSK2585823 in healty Japanese subjects. [J Clin Therapeut Med]. 2012;(September):867-876.
Medical condition
Acne Vulgaris
Product
benzoyl peroxide, benzoyl peroxide/clindamycin phosphate, clindamycin phosphate
Collaborators
Not applicable
Study date(s)
November 2010 to February 2011
Type
Interventional
Phase
1
Participation criteria
Sex
Female & Male
Age
20 - 45 years
Accepts healthy volunteers
Yes
- 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.
- 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.
Inclusion and exclusion 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
Trial location(s)
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Study complete
Actual primary completion date
Not applicable
Actual study completion date
2011-15-02
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
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