CompletedPhase 3ACTRN12612000602820

The treatment of melasma by silymarin cream

Safety and efficacy of topical Silymarin (SM) cream in a randomized double-blind placebo controlled study for treatment of melasma patients.

Sponsor

D Tagreed Altaei

Enrollment

100 participants

Start Date

Jun 12, 2007

Study Type

Interventional

Conditions

Melasma

Summary

Patients were randomized in a double-blind manner to receive one treatment of the tested drugs; group I (G I) SM (7 mg/ml) cream, group II (G II) SM (14 mg/ml) cream, or group III (G III) placebo, applied topically to the affected areas, twice daily for 4 weeks, all advised to avoid sun exposure and to use topical sunscreen with sun protection factor (SPF) of 15+ during the entire period of treatment and thereafter. The patients were seen regularly every week for one month to assess; the response to treatment was rated by the size of lesions. Skin pigment evaluation by melasma area and severity index (MASI), physician global assessment (PGA) by an independent observer, and record the presence of any side effect. The Subjective assessment depending on recording improvement in patient satisfaction measures during the time course, and graded as follows: Grade 0 =not satisfied, Grade 1 =moderately or partially satisfied, Grade 2 =greatly but not fully satisfied, Grade 3 =fully or completely satisfied.

Eligibility

Sex: Both males and femalesMin Age: 20 YearssMax Age: 70 Yearss

Plain Language Summary

Simplified for easier understanding

This study, "The treatment of melasma by silymarin cream", is a clinical trial looking into important health questions. You may be eligible if: - You are between 20 years and 70 years old - The inclusion criteria were adults with melasma without any topical, systemic, laser, and surgical treatment on face during the previous 3 months. Each subject signed a written informed consent. You may NOT be eligible if: - The exclusion criteria were pregnant and nursing women, patients with history of hypersensitivity to some of the components of the formulas of the study, and coexistence of associate diseases and other pigmentation diseases, and concomitant use of other skin care products or systemic treatments. Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Patients were randomized in a double-blind manner to receive one treatment of the tested drugs; 1- Group I (G I) Silymarin (7 mg/ml) cream, applied topically to the affected areas; twice daily for 4

Patients were randomized in a double-blind manner to receive one treatment of the tested drugs; 1- Group I (G I) Silymarin (7 mg/ml) cream, applied topically to the affected areas; twice daily for 4 weeks, and advised to avoid sun exposure and to use topical sunscreen with sun protection factor (SPF) of 15+ during the entire period of treatment and thereafter. 2- Group II (G II) Silymarin (14 mg/ml) cream, applied topically to the affected areas; twice daily for 4 weeks, and advised to avoid sun exposure and to use topical sunscreen with sun protection factor (SPF) of 15+ during the entire period of treatment and thereafter.