To evaluate in Human volunteers bioequivalence of Clobetz Cream (Clobetasol propionate USP 0.05% w/w)with Reference Listed Drug Tenovate Cream (Clobetasol propionate BP 0.05% w/w) , by comparison of vaso constriction caused.
- Conditions
- should be responders to the drug (have demonstrated blanching response)Phototype III and IV.
- Registration Number
- CTRI/2012/08/002893
- Lead Sponsor
- Apex Laboratories Pvt
- Brief Summary
- For screening, aclinical examination performed to verify inclusion criteria and exclusion criteria.
- After the clinical examinations, the referencelisted drug Tenovate Cream will beapplied at any 2 sites on the body (as determined), except on the inner forearmof b
- The applied product will be left non occluded for a period of 4 hours after which the product will be wiped gently with a cotton swab or washed with a mild cleanser.
- Visual assessment of the site will be carried out, 2 hours after the product has been wiped, in order to detect **Responder Status** of the volunteer. Subjects who have the capacity to vasoconstrict when dosed with the Reference Listed drug used in the study are called Responders. Dose duration of 4 hours or 6 hours is suggested with skin blanching assessment 0-4 hours following drug product removal. A responder shows a visual reading of at least one unit.
- On being detected as a Responder, volunteer will be considered for the study.
- The forearm of each volunteer will be cleaned with water and the volunteer will be acclimatised under controlled conditions for 2 hours at the beginning of the trial.
- **8** patches of 4 cm2area will be marked on flexor surface of the subjects’ forearm
- Baseline measurements will be carried out thereafter.
- Following which approximately 5 mg/cm2 of the Reference listed product (quantity depending on patch size and potency of drug) will be massaged on 6 patches on forearm randomly for 1 min using a fingerstall. There will be 2 control sites on forearm and will be left untreated as reference sites.
- Following application, all the patches will be kept open.
- Of the 6 product patches applied on forearm ( D1, D2, 2 TP, 2 RLD) the patches marked TP (test) and RLD (reference) will be kept non occluded for dose duration equal to ED50, D1 and D2 as pre decided.
- Vasoconstriction will be measured by the degree of skin blanching observed using a Spectrophotometer (‘a’ scale reading) and Evaluations will be performed at pre-dose (baseline) and at 0, 2, 4, 6, 19 and 24 hours after removal of product .
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 150
- Subjects should be responders to the drug (have demonstrated blanching response to RLD- Tenovate 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.
- Persons who would require shaving ventral forearms to ensure consistent dose on skin surface.
- Pregnant as confirmed by UPT or lactating women.
- Consumption on average of more than 6 cups (500 mg caffeine) of caffeine containing beverages daily.
- 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 • Evaluation of Vaso-constriction property of products using Spectrophotometer (‘a’ scale readings), which will help determine AUEC values needed for the comparison of the products for In-vivo Bioequivalence Study. • Evaluation of Vaso-constriction property of products using Spectrophotometer (‘a’ scale readings), which will help determine AUEC values needed for the comparison of the products for In-vivo Bioequivalence Study.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
C.L.A.I.M.S. PVT.LTD
🇮🇳Mumbai, MAHARASHTRA, India
C.L.A.I.M.S. PVT.LTD🇮🇳Mumbai, MAHARASHTRA, IndiaDr Rajiv JoshiPrincipal investigatorrsjdr@rediffmail.com