Comparison of Topical Silymarin With Hydroquinone in the Treatment of Melasma
|ClinicalTrials.gov Identifier: NCT03982849|
Recruitment Status : Not yet recruiting
First Posted : June 12, 2019
Last Update Posted : June 12, 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|
|Estimated Study Start Date :||July 2019|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||January 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.
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|
|Principal Investigator:||Sumaira Abdullah, MBBS, MCPS, MD||Senior Registrar in Dermatology|