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Evaluation of the efficacy and safety of topical application of polyherbal unani formulation in the management of Melasma

Phase 2
Conditions
Health Condition 1: L80-L99- Other disorders of the skin and subcutaneous tissue
Registration Number
CTRI/2024/02/063053
Lead Sponsor
Hakim Syed Ziaul Hasan Government Unani Medical College and Hospital
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot Yet Recruiting
Sex
Not specified
Target Recruitment
0
Inclusion Criteria

1 Clinically diagnosed patients of Kalf (Melasma) by wood’s lamp examination.

2 Patients with Fitzpatrick skin types III, IV and V

3 Patients of all sexes.

4 Patients who are willing to sign the written consent form prior to participation in the study.

Exclusion Criteria

1 Pregnant and lactating women.

2 Patients having used any cosmetic depigmenting agent within 2 weeks prior to inclusion in the study.

3 Female on oral contraceptives and hormone therapy at the time of study.

4 Patients having used topical or systemic corticosteroid within 1 month prior to inclusion in the study.

5 Patients having history of laser treatment or dermabrasion or deep facial peels within the past 3 months.

6 Patients who have a known history or clinically relevant allergy, to any study medication components.

7 Patients who have a known history of renal insufficiency, severe liver or heart diseases, neurological disorders, malignancy, HIV infection, AIDS, etc.

8 Patients unlikely to comply with the study protocol.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
• modified Melasma Area Severity Index (mMASI) <br/ ><br>• Patient Global <br/ ><br>Assessment (PtGA)Timepoint: Baseline,2nd week, 4th week and 6th week
Secondary Outcome Measures
NameTimeMethod
Melasma quality of life scale (MELASQoL)Timepoint: Baseline and 6th week
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