None listed
Conditions
Brief 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.
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 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 s
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.
Sponsors
D Tagreed Altaei
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
20 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
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.
Exclusion criteria
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.
Outcome results
None listed