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Comparison of Topical Silymarin With Hydroquinone in the Treatment of Melasma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03982849
Recruitment Status : Recruiting
First Posted : June 12, 2019
Last Update Posted : September 19, 2019
Information provided by (Responsible Party):
Sumaira Abdullah, Islamabad Medical and Dental College

Brief Summary:
A randomized clinical trial will be done on 92 patients , randomly divided into two groups by lottery method to compare the efficacy and safety of topical silymarin cream 0.7% with topical 4% hydroquinone cream. Patients will be treated for 3 months and for the next 3 months will be followed up for relapse of melasma.

Condition or disease Intervention/treatment Phase
Melasma Drug: Hydroquinone 4% Cream Drug: silymarin 0.7% cream Phase 2

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 92 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. 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

Secondary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Female sex.
  • Age 18 or older.
  • Melasma of different severities, types and patterns

Exclusion Criteria:

  • Pregnant or lactating females (Hydroquinone has pregnancy category C and it is not known if it is distributed in breast milk or not).
  • Ongoing use of hormonal birth control pills or any hormonal therapy (as they cause hyperpigmentation).
  • Use of topical anti melasma therapy within 3 months (efficacy of current therapy cannot be concluded).

    • Use of topical steroids within 3 months (as topical steroids will decrease hyperpigmentation).

Information from the National Library of Medicine

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 identifier (NCT number): NCT03982849

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Contact: Naila Hadi, MBBS, M. Phil, PhD +92 300 9209512
Contact: Afaq Ahmad, MBBS, FCPS +92 333 5117976

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Islamabad medical and Dental College Recruiting
Islamabad, Federal, Pakistan, 44000
Contact: Professor   
Contact: Professor   
Principal Investigator: Sumaira Abdullah, MCPS         
Sub-Investigator: Afaq Ahmed, FCPS         
Sponsors and Collaborators
Islamabad Medical and Dental College
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Principal Investigator: Sumaira Abdullah, MBBS, MCPS, MD Senior Registrar in Dermatology

Additional Information:
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Responsible Party: Sumaira Abdullah, Senior Registrar, Islamabad Medical and Dental College Identifier: NCT03982849     History of Changes
Other Study ID Numbers: IMDC
First Posted: June 12, 2019    Key Record Dates
Last Update Posted: September 19, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sumaira Abdullah, Islamabad Medical and Dental College:
Additional relevant MeSH terms:
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Pigmentation Disorders
Skin Diseases
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Radiation-Protective Agents