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A randomized, double-blind, split-face study of topical silymarin versus 2% hydroquinone cream in melasma

Phase 2
Completed
Conditions
Melasma
Melasma, Silymarin, Hydroquinone, Silibinin
Registration Number
TCTR20210729003
Lead Sponsor
/A
Brief Summary

After treatment, both sides showed significant improvement of RL*I. Mean improvement rates of RL*I were 14.56% (SD 43.09) and 12.82 % (SD 38.19) for silymarin and hydroquinone respectively. Modified MASI score decreased after both treatments but was only significant on the hydroquinone side after the first month of treatment (% reduction of modified MASI 17.98%, P 0.019). However, there were no statistically significant differences in the RL*I and modified MASI between the two treatments.

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Female
Target Recruitment
23
Inclusion Criteria

25 female patients with epidermal or mixed-type melasma on both cheeks

Exclusion Criteria

1.Patients with pregnancy and lactation
2. Received hormonal therapy or contraceptive pills within 1 year
3. Received any topical treatment within 1 month
4. Received laser treatment within 3 months
5. Having other facial dermatologic conditions or present of any life-threatening underlying diseases

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
The severity of melasma 12 weeks modified MASI score, relative lightness index,Patient-self assessment 12 weeks VAS
Secondary Outcome Measures
NameTimeMethod
Adverse effects 12 weeks All occurring adverse effects of silymarin and hydroquinone were recorded at each visit
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