To evaluate in Human volunteers bioequivalence of Motyvate Cream with Reference Listed Drug Elocon Cream , by comparison of vaso constriction caused.
- Registration Number
- CTRI/2013/01/003275
- Lead Sponsor
- Apex Laboratories Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 30
1. Subjects should be responders to the drug (have demonstrated blanching response to RLD- Elocon Cream)
2. Phototype III and IV.
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. 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