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.

Evaluation of in-vivo bioequivalence, by comparison of vaso constriction caused by Test Product Clobetz Cream with Reference Listed Drug Tenovate Cream

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2012/08/002893

Enrollment

150

Registered

2012-08-16

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Clobetz Cream: Clobetasol propionate USP 0.05% w/w Route of application: Topical application on marked test sites. Dose duration: 30 mins Control Intervention1: Tenovate Cream: Clobet

Eligibility

Inclusion criteria

Inclusion criteria: - 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).

Exclusion criteria

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. - 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.

Design outcomes

Primary

Measure	Time frame
â?¢ Evaluation of Vaso-constriction property of products using Spectrophotometer (â??aâ?? scale readings), which will help determine AUEC values needed for the comparison of the products for In-vivo Bioequivalence Study.Timepoint: â?¢ Evaluation of Vaso-constriction property of products using Spectrophotometer (â??aâ?? scale readings), which will help determine AUEC values needed for the comparison of the products for In-vivo Bioequivalence Study.	—

Measure

Time frame

â?¢ Evaluation of Vaso-constriction property of products using Spectrophotometer (â??aâ?? scale readings), which will help determine AUEC values needed for the comparison of the products for In-vivo Bioequivalence Study.Timepoint: â?¢ Evaluation of Vaso-constriction property of products using Spectrophotometer (â??aâ?? scale readings), which will help determine AUEC values needed for the comparison of the products for In-vivo Bioequivalence Study.

—

Secondary

Measure	Time frame
NoneTimepoint: Not applicable	—

Countries

India

Contacts

Public ContactDr CN Narayanan

C.L.A.I.M.S. PVT.LTD

rsjdr@rediffmail.com66758851

Outcome results