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Trial registered on ANZCTR


Registration number
ACTRN12612000602820
Ethics application status
Approved
Date submitted
29/05/2012
Date registered
5/06/2012
Date last updated
5/06/2012
Type of registration
Retrospectively registered

Titles & IDs
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.
Secondary ID [1] 280578 0
Nil
Universal Trial Number (UTN)
U1111-1131-3064
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Melasma 286580 0
Condition category
Condition code
Skin 286855 286855 0 0
Dermatological conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 284966 0
Treatment: Drugs
Comparator / control treatment
Group III (G III) placebo; aqueous cream base without the active ingredient (silymarin), applied topically to the affected areas; twice daily for 4 weeks, and the patients 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.
Control group
Placebo

Outcomes
Primary outcome [1] 287210 0
The patients were seen regularly every week for one month to assess; the response to treatment was rated by the size of lesions.
Timepoint [1] 287210 0
Baseline, and then follow up weekly for 4 weeks
Primary outcome [2] 287233 0
Skin pigment evaluation by melasma area severity index (MASI)
Timepoint [2] 287233 0
Baseline, and then follow up weekly for 4 weeks
Primary outcome [3] 287234 0
physician global assessment (PGA) by an independent observer
Timepoint [3] 287234 0
Baseline, and then follow up weekly for 4 weeks
Secondary outcome [1] 297639 0
Record the presence of any side effect; allergy, sensitivity.
Timepoint [1] 297639 0
weekly for 4 weeks
Secondary outcome [2] 297687 0
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.
Timepoint [2] 297687 0
weekly for 4 weeks

Eligibility
Key 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.
Minimum age
20 Years
Maximum age
70 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
After diagnosis by a dermatologist, the trial manager decided which one was eligible according to the inclusion criteria. Each patient had a unique code number in the first visit, these numbers were entered in the computer software.
The allocation was done by central randomization by computer.



allocation schedule by trial manager
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 4339 0
Iraq
State/province [1] 4339 0
Baghdad

Funding & Sponsors
Funding source category [1] 285340 0
Self funded/Unfunded
Name [1] 285340 0
D Tagreed Altaei
Address [1] 285340 0
College of Pharmacy, Hawler Medical University, Erbil, Kurdistan Iraq 44001
Country [1] 285340 0
Iraq
Primary sponsor type
Individual
Name
D Tagreed Altaei
Address
College of Pharmacy, Hawler Medical University, Erbil, Kurdistan Iraq 44001
Country
Iraq
Secondary sponsor category [1] 284192 0
None
Name [1] 284192 0
Address [1] 284192 0
Country [1] 284192 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287351 0
University of Baghdad/ College of Dentistry
Ethics committee address [1] 287351 0
University of Baghdad/ College of Dentistry/ Bab almoadham, Baghdad, Iraq, 10047
Ethics committee country [1] 287351 0
Iraq
Date submitted for ethics approval [1] 287351 0
Approval date [1] 287351 0
02/06/2007
Ethics approval number [1] 287351 0

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34240 0
Address 34240 0
Country 34240 0
Phone 34240 0
Fax 34240 0
Email 34240 0
Contact person for public queries
Name 17487 0
D Tagreed Altaei
Address 17487 0
College of Pharmacy, Hawler Medical University, Erbil, Kurdistan Iraq 44001
Country 17487 0
Iraq
Phone 17487 0
+964 7504941834
Fax 17487 0
Email 17487 0
tagreedaltaei@yahoo.com
Contact person for scientific queries
Name 8415 0
D Tagreed Altaei
Address 8415 0
College of Pharmacy, Hawler Medical University, Erbil, Kurdistan Iraq 44001
Country 8415 0
Iraq
Phone 8415 0
+964 7504941834
Fax 8415 0
Email 8415 0
tagreedaltaei@yahoo.com

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary