Healthy Thai Volunteers Healthy Thai Volunteers
Conditions
Interventions
Generic Topical 0.1% mometasone furoate cream,Elomet Cream
Experimental Other,Active Comparator Other
0.1% Mometasone Furoate Cream,0.1% Mometasone Furoate Cream
Sponsors
International Bio Service
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: 1. Healthy male and/or female subjects between the ages of 18 and 55 years, inclusive (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, physical examination including vital signs measurement, 12-lead ECG and clinical laboratory tests.) 2. Body Mass Index between 18.0 to 25.0 kg/m2. 3. Have voluntarily given written informed consent (signed and dated) by the subject to participate in this study. 4. Willing to follow study restrictions and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures. 5. Subjects have skin type III, IV, V, VI as categorized by Fitzpatrick Skin Type (13-16). (See how to evaluate the Fitzpatrick skin type in the section below.) 6. Absence of significant diseases or clinically significant abnormal laboratory values on the laboratory evaluations, medical history or physical examination during screening. Some of the laboratory values e.g. complete blood count etc that is out of the normal or reference range will be carefully considered by the clinical investigator. 7. Subjects demonstrate adequate vasoconstriction to topical corticosteroids as -good responder- (See details in the section below and in the Section IV (E) in the Guidance of Topical Dermatologic Corticosteroid: In Vivo Bioequivalence, 2 June 1995.)
Exclusion criteria
Exclusion criteria: 1. History of hypersensitivity or adverse reaction to systemic corticosteroids or topical mometasone furoate cream/cream or or any of the excipients of this product. 2. Have high risk for coronavirus infection based on risk assessment questionnaire or diagnosed as confirmed case of COVID-19 3. Clinically significant hypertension or circulatory diseases. 4. Individuals smoking within one week of study. 5. Caffeine intake greater than 500 mg per day prior to or during the study. (A cup of coffee contains about 85 mg of caffeine.) 6. Clinically significant history of alcoholism or drug abuse. 7. Use of topical dermatologic drug therapy on ventral forearms, including prior dosing of a topical corticosteroid in a pharmacodynamic study to a particular skin site, within one month prior to the study. 8. Persons who have history of allergy or side effect from methylhydroxybenzoate, Imidurea, and propyl hydroxybenzoate. 9. Any current or past medical conditions, including active dermatitis or any other dermatologic conditions, which might significantly affect pharmacodynamic response to the administered drug. 10. Persons who would require shaving ventral forearms to insure consistent dose on skin surface. 11. Use of any vasoactive (constrictor or dilator) medication, prescription or OTC, that could modulate blood flow. Examples of such drugs include nitroglycerin, antihypertensives, antihistamines, NSAID, aspirin, and OTC cough/cold products containing antihistamines and/or either phenylpropanolamine or phentolamine. 12. Any obvious difference in skin color between arms. 13. Persons who have livedo racemosa. 14. Females who are pregnant.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| vasoconstriction of the skin microvasculature 0.25, 0.5, 0.75, 1.0, 2.0, 4.0, 6.0 hours Pharmacodynamic | — |
Secondary
| Measure | Time frame |
|---|---|
| N/A N/A N/A | — |
Countries
Thailand
Contacts
Public ContactPorranee Puranajotu
International Bio Service
Outcome results
None listed