Phase
Condition
Rash
Allergy
Dermatitis, Atopic
Treatment
N/AClinical Study ID
Ages 20-64 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Japanese males and females aged between 20 and 64 years of age inclusive, at the timeof signing the informed consent.
Healthy as determined by a responsible and experienced physician, based on a medicalevaluation including medical history, physical examination, laboratory tests and 12-lead ECG. A subject with a clinical abnormality or laboratory parameter(s) whichis/are not specifically listed in the inclusion or exclusion criteria, outside thereference range for the population being studied may be included only if theInvestigator in consultation with the GlaxoSmithKline (GSK) Medical Monitor ifrequired agree and document that the finding is unlikely to introduce additional riskfactors and will not interfere with the study procedures.
Healthy skin in the potential test site on the back such that erythema and otherdermal reactions can be easily visualized.
Body Mass Index within the range 18.5 - 24.9 kilogram per square meter (kg/m^2,inclusive) and less than 25.0 kg/m^2.
A female subject is eligible to participate if she is of: Non-childbearing potentialdefined as pre-menopausal females with a documented tubal ligation or hysterectomy; orpostmenopausal defined as 12 months of spontaneous amenorrhea with simultaneousfollicle stimulating hormone (FSH) > 40 milli-international units per milliliter andestradiol < 40 picograms per milliliter (<147 picomole per liter).
Capable of giving written informed consent, which includes compliance with therequirements and restrictions listed in the consent form
Alanine aminotransferase (ALT), alkaline phosphatase and bilirubin <= 1.5x upper limitof normal (ULN) (isolated bilirubin >1.5xULN is acceptable if bilirubin isfractionated and direct bilirubin <35%).
Based on single QTc values: QT interval corrected for heart rate according toFridericia's formula (QTcF) < 450 milliseconds; QTcF < 480 msec in subjects withBundle Branch Block.
Exclusion
Exclusion Criteria:
Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
History of known or suspected intolerance to any of the ingredients of the studyproducts, adhesive tape/plaster, or the test patches.
Subjects with inherent sensitivity to sun or history of photosensitivity.
Inability to evaluate the skin at and around the potential test sites on the back dueto sunburns, unevenness in skin tone, tattoos, scars, excessive hair, freckles,birthmarks, moles, or other skin damage or abnormality.
Clinically-relevant skin disease, including psoriasis, eczema, atopic dermatitis,acne, dysplastic nevi, or other skin pathologies, or a history of skin cancer, thatmay, in the opinion of the investigator, contraindicate participation or interferewith test site evaluations.
Considered immunocompromised, or has a clinically-relevant history of or currentlysuffering from any disease or condition that, in the opinion of the investigator,might affect the evaluation of the study product or place the subject at undue risk.
A positive pre-study syphilis, Hepatitis B surface antigen, Hepatitis C antibody,Human Immunodeficiency Virus antigen antibody or Human T-cell Lymphotropic Virus-1result of screening.
A positive pre-study drug screen.
The subject has donated a unit of blood ">400 milliliter (mL)" within the previous 4months or ">200 mL" within the previous 1 month prior to the first dosing day.
The subject has participated in a clinical study with an investigational or anon-investigational drug or device during the previous 4 months prior to the firstdosing day.
Exposure to more than four new chemical entities within 12 months prior to the firstdosing day.
The subject planned to concurrently participate in another clinical study orpost-marketing study.
Use of prescription or non-prescription drugs, including vitamins, herbal and dietarysupplements (including St John's Wort) within 14 days prior to the first applicationof study medication.
Unwillingness or inability to follow the procedures outlined in the protocol.
Subject is mentally or legally incapacitated.
Study Design
Connect with a study center
GSK Investigational Site
Fukuoka, 812-0025
JapanSite Not Available

Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.