To evaluate in Human volunteers bioequivalence of Flutisone Cream (Fluticasone propionate BP 0.05% w/w)with Reference Listed Drug Flutivate Skin Cream (Fluticasone propionate IP 0.05% w/w) , by comparison of vaso constriction caused.
- Registration Number
- CTRI/2012/08/002881
- Lead Sponsor
- Apex Laboratories Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 30
Subjects should be responders to the drug (have demonstrated blanching response to RLD Flutivate Skin Cream )
-Phototype III and IV.
-Age: 18-45 years.
-Has been fully informed and willing to sign Informed Consent Document.
-Non-tobacco-using subjects.
-Presenting normal healthy skin type
-Cooperating, informed of the need and duration of the examinations.
-For which the investigator considers that the compliance will be correct.
-Healthy Subjects (Healthy/ Good health as demonstrated by lack of clinically significant abnormalities in medical history and clinical assessment, as judged by the Investigator).
-Clinically significant hypertension or circulatory disease.
-Chronic illness which may influence the skin sensitivity.
-History of allergy to any cosmetic product/ topical application.
-Subject in an exclusion period or participating in another cosmetic or therapeutic trial.
-Presence of any skin condition or pigmentation that would interfere with the placement of test sites or the response or assessment of skin blanching.
-Subjects on any medical treatment either systemic or topical presently or in the past 1 month).
-Drug or alcohol addiction requiring treatment (in-patient or out-patient) in the 12 months prior to dosing.
-Any obvious difference in skin color between arms.
-Use of any vasoactive (constrictor or dilator) medication, prescription or OTC, that could modulate blood flow.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method