To evaluate in Human volunteers bioequivalence of Motyvate Cream with Reference Listed Drug Elocon Cream , by comparison of vaso constriction caused.

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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2013/01/003275

Enrollment

150

Registered

2013-01-01

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: Motyvate Cream: Mometasone Furoate USP 0.1% w/w Route of application: Topical application on marked test sites. Dose duration: 70 mins, 140 mins and 280 mins. Control Intervention1: E

Eligibility

Inclusion criteria

Inclusion criteria: 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).

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

Measure	Time frame
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: 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

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: 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