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To Evaluate and compare effect and skin safety of Clobetasol gel (Clobetasol Propionate USP 0.05% w/w) and Clobetasol Cream (Clobetasol Propionate BP 0.05% w/w) in patients with mild to moderate psoriasis

Phase 4
Completed
Conditions
Health Condition 1: null- mild to moderate Psoriasis
Registration Number
CTRI/2013/02/003430
Lead Sponsor
Curatio Healthcare Pvt Ltd
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Not specified
Target Recruitment
28
Inclusion Criteria

1.Voluntary men/women with clinically diagnosed mild to moderate stable, chronic, plaque psoriasis.

2. 2.At least one, discrete, well circumscribed lesion approximately 20 cm2 â?? 80 cm2 on trunk separated from adjacent lesions by at least 3 cms.The same lesion will be tracked through the entire study.

3.Age between 18 â?? 55 years

4.Not on treatment for psoriasis- oral since 1 month and topical since 2 weeks.

5.Accepting not to use products with the same end benefit during the entire study duration.

6.Cooperating, informed of the need and duration of the examinations, and ready to comply with protocol procedures.

7.Having signed a Consent Form and will be informed orally and in writing of all information concerning the study procedures and study objectives.

Exclusion Criteria

1.Pustular psoriasis, Palmoplanter and erythrodermic psoriasis.

2.Pregnant women (as confirmed by UPT) and lactating women.

3.History of allergic dermatitis or contact allergy to cosmetics,

4.Hypersensitivity to any cosmetic product, raw material.

5.For whom the Investigator considers that he/she will not be compliant with study procedures.

6.Any clinically significant systemic or cutaneous disease, which may interfere with study treatments or procedures.

7.Subjects on any medical treatment either systemic or topical which may interfere with the performance of the study treatment (presently or in the past 1 month).

8.Subject in an exclusion period or participating in another similar cosmetic or therapeutic trial.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
â?¢Clinical Evaluation using LASI scale.Timepoint: â?¢Day 0, 10 days,20 days and 30 days
Secondary Outcome Measures
NameTimeMethod
In use skin safety of Clobetasol gel (Clobetasol Propionate USP 0.05% w/w) and Clobetasol Cream (Clobetasol Propionate BP 0.05% w/w).Timepoint: â?¢Day 0, 10 days,20 days and 30 days
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