Comparison of a New Masterful Preparation to Kligman's Trio in the Treatment of Melasma (Kligman)

March 20, 2026 updated by: Centre Hospitalier Universitaire de Nice

Comparison of a New Masterful Preparation to Kligman's Trio in the Treatment of Melasma: a Double Blind Prospective Randomzed Study

Kligman's trio remains the gold standard treatment for melasma. It contain hydroquinone which is an effective anti-melanogenic compound but that has poor tolerance and numerous side-effects. Thiamidol has been proven to be at least as effective as hydroquinone and has a very good safety profile. The objective of this study is to compare the Kligman's trio to the same preparation in which hydroquinone is replaced by thiamidol.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Alpes-maritimes
      • Nice, Alpes-maritimes, France, 06200
        • CHU de Nice

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • SIGNED WRITTEN CONSENT 1) Melasma clinically diagnosed

Exclusion Criteria:

  1. Pregnant woman
  2. Other pigmentary disorder affecting the face
  3. Use of systemic or topical steroids or retinoids, use of topical depigmenting agents or depigmenting procedure in the month before the inclusion

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: New traitement
Thiamidol, retinoid, topical steroid preparation
Drug: New trio de Kligman
Once daily application in addition to the same sunscreen
Other: Kligman's trio
Application once a day for 12 weeks
Drug: Trio Kligman
Once daily application in addition to the same sunscreen

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The melasma's type
Time Frame: at 12 weeks
Clinical score MASI
at 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the Quality of life of patient
Time Frame: at 12 weeks
descriptive name of scale : meslascol
at 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Nice

Investigators

  • Principal Investigator: Thierry Passeron, PhD, CHU de Nice, Service de Dermatologie

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 30, 2021

Primary Completion (Actual)

September 16, 2022

Study Completion (Actual)

December 15, 2022

Study Registration Dates

First Submitted

October 4, 2021

First Submitted That Met QC Criteria

November 12, 2021

First Posted (Actual)

November 15, 2021

Study Record Updates

Last Update Posted (Actual)

March 24, 2026

Last Update Submitted That Met QC Criteria

March 20, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20-PP-30

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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