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A pilot study of effectiveness of a topical cosmetic containing 5% alpha-arbutin combination with 2% kojic acid comparing with triple combination cream in treatment of melasma : A split-face, evaluator blinded randomized trial

Phase 2
Completed
Conditions
Melasma
Melasma, Melasma treatment, Triple combination cream, 5% Alpha-Arbutin, 2% Kojic acid
Registration Number
TCTR20230124004
Lead Sponsor
Institute of dermatology
Brief Summary

The hemi-mMASI score and MI were not statistically different between TCC and 5% alpha-arbutin combination with 2% kojic acid, but the PGA score improved significantly in the TCC treated side. Most patients had recurrence with statistically significant increased pigmentation on TCC treated side, with a significant mean difference between MI of TCC and AA+KA. Even though patient satisfaction was greater in TCC, erythema was the most strongly affected.

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
All
Target Recruitment
27
Inclusion Criteria

adult between 25- 60 years having a clinical diagnosis of bilateral melasma.

Exclusion Criteria

allergic to alpha-arbutin, kojic acid, hydroquinone, tretinoin and fluocinolone acetonide, using medication including hydroquinone, azelaic acid, retinoid, tranexamic acid, skin care products containing AHA, Niacinamide, ascorbic acid, history of chemical peeling and LASER within three months prior to enrolling in the study, pregnancy and lactation.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Melasma 4th wk, 8th wk, 12th wk and after discontinuing treatment 4 wks Hemi-mMASI score,Melasma 4th wk, 8th wk, 12th wk and after discontinuing treatment 4 wks Melanin index,Melasma 4th wk, 8th wk, 12th wk Physician global assessment score
Secondary Outcome Measures
NameTimeMethod
Side effect 4th wk, 8th wk, 12th wk and after discontinuing treatment 4 wks Investigator assesment,Patient satisfaction after completing of treatment (12 weeks) Patient assessment
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