Comparative Efficacy of Resveratrol 1 % Gel and Trichloroacetic Acid 20% in Treatment of Melasma: A Split-face Study

NCT07060157 | Not Yet Recruiting DMC

• 1 other identifier: resveratrol in melasma
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

Brief Summary

1. 1.To evaluate the efficacy and safety of topical resveratrol 1 % gel in treatment of melasma.
2. 2.To compare between the efficacy of topical resveratrol 1 %gel versrs chemical peeling with TCA 20% in melasma.

Conditions

Melasma

Keywords

resveratrol in melasma

Outcome Measures

Primary Outcomes (1)

• The primary outcome is the change in hemi-Melasma Area and Severity Index (hemi-MASI) score from baseline to one month after the end of treatment (follow-up)

  assessed by clinical evaluation and photographic documentation. Clinical efficacy will be categorized as: Excellent response: \>75% decrease in hemi-MASI score Very good response: 50-75% decrease in hemi-MASI score Good response: 25-50% decrease in hemi-MASI score Poor response: \<25% decrease in hemi-MASI score

  3 months

Study Arms (2)

Group A

ACTIVE COMPARATOR

left side of face the patient will be given resveratrol 1 % gel once daily at night (homThee use ).

Drug: resveratrol 1 % gel

Group B

ACTIVE COMPARATOR

The right side of face will treated with TCA20% every two weeks for 3months.

Drug: TCA20%

Interventions

resveratrol 1 % gel DRUG

left side of face the patient will be given resveratrol 1 % gel once daily at night (Home use ).

Also known as: 1

Group A

TCA20% DRUG

left side of face the patient will be given resveratrol 1 % gel once daily at night (homThee use ).

Group B

Eligibility Criteria

• Age: 18 Years - 50 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age: 18-50 years old.
• Pattern of melasma: Bilateral symmetrical facial melasma of any pattern.
• Fitzpatrick skin phototypes: Types III, IV and V.

You may not qualify if:

• Pregnancy and lactation.
• Patients taking oral contraceptive pills, hormonal replacement therapy or treatment for chronic illness at the time of the study or during the past 6 months.
• Coexistence of diseases associated with hyperpigmentation such as Addison disease.
• History of Scarring and keloid tendency
• Active skin infections as active HSV.
• Previous history of post- inflammatory hyperpigmentation.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assuit

Asyut, Egypt

Location

MeSH Terms

Conditions

Melanosis

Interventions

Resveratrol; Gels

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Stilbestrols; Stilbenes; Benzylidene Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polyphenols; Phenols; Colloids; Complex Mixtures; Dosage Forms; Pharmaceutical Preparations

Central Study Contacts

amira mohamed bakry, Resident doctor of Dermatology

CONTACT

+201014524304; amirakedwany@icloud.com

Dalia Abdel-Aziz Ahmed Attallah, Professor of Dermatology

CONTACT

+201005677229; daliaattallah@aun.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: doctor

Study Record Dates

• First Submitted: March 21, 2025
• First Posted: July 11, 2025
• Study Start: July 22, 2025
• Primary Completion (Estimated): August 8, 2026
• Study Completion (Estimated): June 8, 2027
• Last Updated: July 11, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share

Locations

EG (1)