Comparison of Topical Silymarin With Hydroquinone in the Treatment of Melasma
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|ClinicalTrials.gov Identifier: NCT03982849|
Recruitment Status : Recruiting
First Posted : June 12, 2019
Last Update Posted : September 19, 2019
|Condition or disease||Intervention/treatment||Phase|
|Melasma||Drug: Hydroquinone 4% Cream Drug: silymarin 0.7% cream||Phase 2|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||92 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Comparison of Topical Silymarin With Hydroquinone in the Treatment of Melasma|
|Actual Study Start Date :||July 15, 2019|
|Estimated Primary Completion Date :||December 31, 2019|
|Estimated Study Completion Date :||January 15, 2020|
Active Comparator: Hydroquinone group
Hydroquinone 4% cream Cream applied once daily at night on affected areas for 3 months.
Drug: Hydroquinone 4% Cream
Hydroquinone is tyrosinase inhibitor and thus inhibits melanogenesis.
Experimental: Silymarin group
Silymarin 0.7% cream Cream applied twice daily on affecectec areas for 3 months.
Drug: silymarin 0.7% cream
Silymarin is a plant derived flavonoid, extracted from fruits and seeds of milk thistle.
- Therapeutic response will be assessed in terms of percent reduction in MASI score from baseline to 1,2 and 3 month of treatment course and for next 3 months of follow up. [ Time Frame: 6 months ]
- >75% improvement as excellent
- 50-75% improvement as good
- 25-50% improvement as medium
- < 25% improvement as poor
- b) Measurement of patient's satisfaction monthly for 6 months by the Short Assessment of Patient Satisfaction (SAPS). [ Time Frame: 6 months ]
- 0 - 10 very unsatisfied.
- 11 - 18 unsatisfied.
- 19 - 26 satisfied.
- 27 - 28 very satisfied.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03982849
|Contact: Naila Hadi, MBBS, M. Phil, PhD||+92 300 email@example.com|
|Contact: Afaq Ahmad, MBBS, FCPS||+92 333 firstname.lastname@example.org|
|Islamabad medical and Dental College||Recruiting|
|Islamabad, Federal, Pakistan, 44000|
|Contact: Professor email@example.com|
|Contact: Professor firstname.lastname@example.org|
|Principal Investigator: Sumaira Abdullah, MCPS|
|Sub-Investigator: Afaq Ahmed, FCPS|
|Principal Investigator:||Sumaira Abdullah, MBBS, MCPS, MD||Senior Registrar in Dermatology|