To compare the blanching (paleness of skin) effect of test product Flucort- H with reference product Tenovate Cream.

To compare the vasoconstrictor assay of test product Flucort- H (0.1%w/w Fluocinolone acetonide) with reference product Tenovate Cream (Clobetasol Propionate BP 0.05% w/w)

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2013/09/003948

Enrollment

Registered

2013-09-03

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: Flucort- H: 0.1%w/w Fluocinolone acetonide. 5 mg/cm2 of the product(quantity depending on patch size and potency of drug) will be massaged on patches on forearm for 1 min using a finge

Eligibility

Inclusion criteria

Inclusion criteria: 1. Subjects should be responders to the drug (have demonstrated blanching response to Reference- Tenovate Cream 2. Phototype III and IV. (Phototype IV- Moderate brown skin which rarely burns and tans with ease. Phototype III (Lower) - White skin which sometimes burns, difficult to tan). 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. Pregnant as confirmed by UPT or lactating women. 10. Consumption on average of more than 6 cups (500 mg caffeine) of caffeine containing beverages daily. 11.Any obvious difference in skin color between arms. 12. 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 for the comparison of the vasoconstrictor assay of test product Flucort- H (0.1%w/w Fluocinolone acetonide) with reference product Tenovate Cream (Clobetasol Propionate BP 0.05% w/w).Timepoint: Evaluation of Vaso-constriction property of products using Spectrophotometer for the comparison of the vasoconstrictor assay of test product Flucort- H (0.1%w/w Fluocinolone acetonide) with reference product Tenovate Cream (Clobetasol Propionate BP 0.05% w/w).	—

Measure

Time frame

Evaluation of Vaso-constriction property of products using Spectrophotometer for the comparison of the vasoconstrictor assay of test product Flucort- H (0.1%w/w Fluocinolone acetonide) with reference product Tenovate Cream (Clobetasol Propionate BP 0.05% w/w).Timepoint: Evaluation of Vaso-constriction property of products using Spectrophotometer for the comparison of the vasoconstrictor assay of test product Flucort- H (0.1%w/w Fluocinolone acetonide) with reference product Tenovate Cream (Clobetasol Propionate BP 0.05% w/w).

—

Secondary

Measure	Time frame
NoneTimepoint: Not applicable	—

Countries

India

Contacts

Public ContactDr Amit Bhargav

C.L.A.I.M.S. Pvt. Ltd.

rsjdr@rediffmail.com66758851

Outcome results