To compare the vasoconstrictor assay of test product Flucort- H (0.1%w/w Fluocinolone acetonide) with reference product Tenovate Cream (Clobetasol Propionate BP 0.05% w/w)

Glenmark Pharmaceuticals Limited0 个研究点目标入组 20 人开始时间: 待定最近更新: 2021年11月24日

试验速览

暂无简介。

•1. Subjects should be responders to the drug (have demonstrated blanching response to Reference- Tenovate Cream
•2. Phototype III and IV. (Phototype IV- Moderate brown skin which rarely burns and tans with ease. Phototype III (Lower) - White skin which sometimes burns, difficult to tan).
•3. Age: 18-45 years.
•4. Has been fully informed and willing to sign Informed Consent Document.
•5. Non-tobacco-using subjects.
•6. Presenting normal healthy skin type
•7. Cooperating, informed of the need and duration of the examinations.
•8. For which the investigator considers that the compliance will be correct.
•9.Healthy Subjects (Healthy/ Good health as demonstrated by lack of clinically significant abnormalities in medical history and clinical assessment, as judged by the investigator).

•1. Clinically significant hypertension or circulatory disease.
•2.Chronic illness which may influence the skin sensitivity.
•3. History of allergy to any cosmetic product/ topical application.
•4. Subject in an exclusion period or participating in another cosmetic or therapeutic trial.
•5. Presence of any skin condition or pigmentation that would interfere with the placement of test sites or the response or assessment of skin blanching.
•6. Subjects on any medical treatment either systemic or topical presently or in the past 1 month).
•7. Drug or alcohol addiction requiring treatment (in-patient or out-patient) in the 12 months prior to dosing.
•8. Persons who would require shaving ventral forearms to ensure consistent dose on skin surface.
•9. Pregnant as confirmed by UPT or lactating women.
•10. Consumption on average of more than 6 cups (500 mg caffeine) of caffeine containing beverages daily.
•11.Any obvious difference in skin color between arms.
•12. Use of any vasoactive (constrictor or dilator) medication, prescription or OTC, that could modulate blood flow

发起方