To evaluate in Human volunteers bioequivalence of Motyvate Cream with Reference Listed Drug Elocon Cream , by comparison of vaso constriction caused.
- Conditions
- Should be responders to the drug (have demonstrated blanching response)
- Registration Number
- CTRI/2013/01/003275
- Lead Sponsor
- Apex Laboratories Pvt Ltd
- Brief Summary
**Screening for Responders**
- Demographic information (age, date of birth etc.)
- Medical history (any illness-presently or in past)
- Prior treatments (medication)
- Clinical examination and evaluation of the test area (examination by doctor)
- Explanation of the Trial and procedures
- Handing out the Informed consent document
- Collecting & documenting informed consent
- Clinical evaluation of test site
- Concomitant treatments
- Application of the reference product to any 2 sites other than the inner forearm for checking of Responder status.
- Removal of product, **6 hrs after product application** by gently dabbing a cotton swab.
- Clinical evaluation of site for Response **2 hrs after product removal**
- If found a Responder, consider for study.
**D0: H0**
· Acclimatize volunteers under controlledconditions for 2 hours.
· Marking of 8 test sites on each forearm.
· The baseline reading using a **Spectrophotometer** at all marked sites.
**D0: ProductApplication**
· Application of approximately 7 mg/cm2the Reference listed product (quantity depending on patch size and potency ofdrug) on 6 patches on each forearm randomly.
· All sites will be kept non occluded afterapplication.
· 2 sites on each forearm kept untreated ascontrol sites.
**D0: Post ProductApplication**
· Leave product nonoccluded on patches marked TP (test) andRLD (reference) for dose duration equal to ED50, D1 and D2 as pre decided.
· Spectrophotometricevaluations at pre-dose (baseline) and at 0, 2, 4, 6, 19 and 24 hours afterproduct removal.
- 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- Elocon Cream) 2.
- Phototype III and IV.
- Age: 18-45 years.
- Has been fully informed and willing to sign Informed Consent Document.
- Non-tobacco-using subjects.
- 6.Presenting normal healthy skin type 7.Cooperating, informed of the need and duration of the examinations.
- 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).
- 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.
- 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