Comparison of Topical Silymarin With Hydroquinone in the Treatment of Melasma

NCT03982849 | Completed Phase 2

• 1 other identifier: IMDC
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

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.

Conditions

Melasma

Keywords

melasma; hydroquinone; silymarin

Outcome Measures

Primary Outcomes (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.

  * \>75% improvement as excellent * 50-75% improvement as good * 25-50% improvement as medium * \< 25% improvement as poor

  6 months

Secondary Outcomes (1)

• b) Measurement of patient's satisfaction monthly for 6 months by the Short Assessment of Patient Satisfaction (SAPS).

  6 months

Study Arms (2)

Hydroquinone group

ACTIVE COMPARATOR

Hydroquinone 4% cream Cream applied once daily at night on affected areas for 3 months.

Drug: Hydroquinone 4% Cream

Silymarin group

EXPERIMENTAL

Silymarin 0.7% cream Cream applied twice daily on affecectec areas for 3 months.

Drug: silymarin 0.7% cream

Interventions

Hydroquinone 4% Cream DRUG

Hydroquinone is tyrosinase inhibitor and thus inhibits melanogenesis.

Hydroquinone group

silymarin 0.7% cream DRUG

Silymarin is a plant derived flavonoid, extracted from fruits and seeds of milk thistle.

Silymarin group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Islamabad Medical and Dental College: lead

Study Sites (1)

Islamabad medical and Dental College

Islamabad, Federal, 44000, Pakistan

Location

Related Publications (1)

• Nofal A, Ibrahim AM, Nofal E, Gamal N, Osman S. Topical silymarin versus hydroquinone in the treatment of melasma: A comparative study. J Cosmet Dermatol. 2019 Feb;18(1):263-270. doi: 10.1111/jocd.12769. Epub 2018 Aug 26.

  PMID: 30146802 BACKGROUND

MeSH Terms

Conditions

Melanosis

Interventions

hydroquinone; Silymarin

Condition Hierarchy (Ancestors)

Hyperpigmentation; Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Flavonolignans; Flavonoids; Chromones; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Sumaira Abdullah, MBBS, MCPS, MD

  Senior Registrar in Dermatology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Registrar

Study Record Dates

• First Submitted: May 27, 2019
• First Posted: June 12, 2019
• Study Start: July 15, 2019
• Primary Completion: December 31, 2019
• Study Completion: January 15, 2020
• Last Updated: February 12, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)