Healthy Volunteers
Conditions
Interventions
0.1% Mometasone cream
Experimental Drug
MODASONE CREAM
Sponsors
T.O. group Thailand
Eligibility
Sex/Gender
All
Age
18 Years to 35 Years
Inclusion criteria
Inclusion criteria: 1) Thai Male/Female must be 18-35 years of age, body mass index (BMI) = 18-25 kg/m2, inclusive. 2) Subjects will be screened to determine blanching response with the reference mometasone cream or Elomet®. Subjects must show clinical response to single dose duration of 4 hours with skin blanching assessment for 2 hours following drug removal. Subjects will be selected based on a demonstrated blanching response or a visual reading on at least one unit. 3) Must be in good health as determined by medical history, physical examination and vital sign. 4) Subjects have no any skin conditions or skin discolorations including skin fissure which would interfere with the response outcome or assessment of skin blanching. 5) Non-smokers (never smoked or no smoking within the previous 2 years). 6) Subjects must refrain from drinking caffeine and alcohol for at least 72 hours and 1 month prior to study day 1, respectively, and agree to continue their refraining throughout the last measureable time-point. 7) Subjects must refrain from use of topical dermatologic drugs and topical corticosteroids within one month prior to the study and agree to continue throughout the study period. 8) Subjects must refrain from use of any vasoactive (constrictor or dilator) medication, prescription or OTC, that could modulate blood flow within one month prior to the study and agree to continue throughout the last measurable time-point. Examples of such drugs include nitroglycerin, antihypertensives, NSAID(s), aspirin, antihistamines and/or either phenypropanolamine or phentolamine. 9) A female subject must have negative for serum ï¢-hCG. 10) Female subject who is childbearing potential agrees to use an acceptable birth control method from visit 1 to the follow up visit. The acceptable birth control method is defined as a barrier method of contraception (including condoms, intrauterine device (IUD), and diaphragm with spermicidal agent) or total abstinence from sexual intercourse from visit 1 to the follow up visit. Hormonal contraceptives are not acceptable. 11) Female subjects must agree not to become pregnant for the entire participation period and must have a negative result for a urine pregnancy test performing prior to dosing (only the first dose). 12) Avoid any local or systemic treatment of corticosteroids during the study. 13) Have the ability to understand the requirements of the study and must voluntarily sign and date an informed consent, approved by an Independent Ethic Committee (IEC)/Institutional Review Board (IRB), prior to the initiation of any screening or study-specific procedures.
Exclusion criteria
Exclusion criteria: 1) Known hypersensitivity to any corticosteroids or to any topical products. 2) Clinically significant hypertension or circulatory disease 3) Any current or past medical conditions, including active dermatitis in any other dermatologic conditions, which might significantly effect for pharmacodynamic response to the administered drug. 4) Past medical history of moderate to severe hepatic insufficiency, biliary cirrhosis or biliary obstruction, primary hyperaldosteronism, bilateral renal artery stenosis. 5) Subject has a history of any illness that, in the opinion of the investigator, might confound the result of the study or pose an additional risk in administering study drug to the subject. This may include but is not limited to: a history of relevant drug or food allergies; history of cardiovascular, gastrointestinal, central nervous system disease, renal and hepatic impairment; history or presence of clinically significant illness; or history of mental illness that may affect compliance with study requirements. 6) Alcohol abuse or excessive use (in the opinion of the investigator, as judged by medical history) in the last 12 months. 7) Any obvious difference in skin color between arms. 8) Participation in any investigation drug study within 1 month. 9) Person who would require shaving ventral forearms to insure consistent dose on skin surface.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Skin blanching response as represented by AUEC Baseline and at 0.00, 2.00, 4.00, 6.00, 8.00, 20.0 and 24.0 hours after drug removal will be measure Mexameter® MX 18 | — |
Secondary
| Measure | Time frame |
|---|---|
| Skin blanching response as represented by AUEC Baseline and at 0.00, 2.00, 4.00, 6.00, 8.00, 20.0 and 24.0 hours after drug removal will be measure Visual score | — |
Countries
Thailand
Contacts
Public ContactThunwarat Jitsukon
T.O. group Thailand
Outcome results
None listed