The treatment of melasma by silymarin cream

Phase 3

Completed

• Conditions: Melasma; Skin - Dermatological conditions

• Registration Number: ACTRN12612000602820
• Lead Sponsor: D Tagreed Altaei

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-06-05
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The patients were seen regularly every week for one month to assess; the response to treatment was rated by the size of lesions.[Baseline, and then follow up weekly for 4 weeks];Skin pigment evaluation by melasma area severity index (MASI)[Baseline, and then follow up weekly for 4 weeks];physician global assessment (PGA) by an independent observer[Baseline, and then follow up weekly for 4 weeks]

Secondary Outcome Measures

Name	Time	Method
Record the presence of any side effect; allergy, sensitivity.[weekly for 4 weeks];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.[weekly for 4 weeks]