Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:34 PM
Ignite Modification Date:
2025-12-24 @ 4:34 PM
NCT ID:
NCT01428466
Eligibility 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
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
45 Years
Study:
NCT01428466
Study Brief:
Protocol Section:
NCT01428466