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.

Phase 4

Completed

• Conditions: Subjects should be responders to the drug (have demonstrated blanching response)

• Registration Number: CTRI/2012/08/002881
• Lead Sponsor: Apex Laboratories Pvt Ltd

Brief Summary

- For screening, a clinical examination performed to verify inclusion criteria and exclusion criteria.

- After the clinical examinations, the reference listed drug Flutivate Skin Cream  will be applied at any 2 sites on the body (as determined), except on the inner forearm of both hands.

- The applied product will be left occluded for a period of 6 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 acclimatized under controlled conditions  for 2 hours at the beginning of the trial.

- **8 patches** of 4 cm2 area will be marked on flexor surface of the subjects’ forearm.

- Baseline measurements will be carried out thereafter.

- Following which approximately 8 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 occluded.

- The 6 product patches applied on forearm (2 TP, 2 RLD, D1, D2) will be kept 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 .

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Detailed Description

Not available

Study Timeline

• Study Start: 2012-08-20
• Study Completion: 2012-09-26
• Last Update Posted: 2018-11-26

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• 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).

Exclusion Criteria

• 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
•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.	Spectrophotometric evaluations at pre-dose (baseline) and at 0, 2, 4, 6, 19 and 24 hours after product removal.

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, India

Dr Rajiv Joshi

Principal investigator

rsjdr@rediffmail.com