The treatment of melasma by silymarin cream

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12612000602820
• Date of registration: 05/06/2012
• Prospective Registration: No
• Primary sponsor: D Tagreed Altaei
• Public title: The treatment of melasma by silymarin cream
• Scientific title: Safety and efficacy of topical Silymarin (SM) cream in a randomized double-blind placebo controlled study for treatment of melasma patients.
• Date of first enrolment: 12/06/2007
• Target sample size: 100
• Recruitment status: Completed
• URL: https://anzctr.org.au/ACTRN12612000602820.aspx
• Study type: Interventional
• Study design: Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Parallel;Type of endpoint: Safety/efficacy;
• Phase: Phase 3

Countries of recruitment

Iraq

Contacts

• Name: D Tagreed Altaei

• Name: D Tagreed Altaei

Key inclusion & exclusion criteria

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.

Age minimum: 20 Years
Age maximum: 70 Years
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Melasma;
Melasma

Skin - Dermatological conditions

Intervention(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.

Primary Outcome(s)

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]

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]

Secondary Outcome(s)

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]

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

Secondary ID(s)

Nil

Source(s) of Monetary Support

D Tagreed Altaei

Ethics review

Status: Approved
Approval date:
Contact:

University of Baghdad/ College of Dentistry