NCT05119413

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Nov 2021

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 4, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 15, 2021

Completed
15 days until next milestone

Study Start

First participant enrolled

November 30, 2021

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 16, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2022

Completed
Last Updated

March 24, 2026

Status Verified

March 1, 2026

Enrollment Period

10 months

First QC Date

October 4, 2021

Last Update Submit

March 20, 2026

Conditions

Melanosis

Outcome Measures

Primary Outcomes (1)

  • The melasma's type

    Clinical score MASI

    at 12 weeks

Secondary Outcomes (1)

  • the Quality of life of patient

    at 12 weeks

Study Arms (2)

New traitement

EXPERIMENTAL

Thiamidol, retinoid, topical steroid preparation

Drug: New trio de Kligman

Kligman's trio

OTHER

Application once a day for 12 weeks

Drug: Trio Kligman

Interventions

New trio de KligmanDRUG

Once daily application in addition to the same sunscreen

New traitement
Trio KligmanDRUG

Once daily application in addition to the same sunscreen

Kligman's trio

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • SIGNED WRITTEN CONSENT 1) Melasma clinically diagnosed

You may not qualify if:

  • Pregnant woman
  • Other pigmentary disorder affecting the face

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Nice

Nice, Alpes-maritimes, 06200, France

Location

Related Publications (1)

  • Bertold C, Fontas E, Singh T, Gastaut N, Ruitort S, Wehrlen Pugliese S, Passeron T. Efficacy and safety of a novel triple combination cream compared to Kligman's trio for melasma: A 24-week double-blind prospective randomized controlled trial. J Eur Acad Dermatol Venereol. 2023 Dec;37(12):2601-2607. doi: 10.1111/jdv.19455. Epub 2023 Sep 4.

    PMID: 37620285RESULT

MeSH Terms

Conditions

Melanosis

Condition Hierarchy (Ancestors)

HyperpigmentationPigmentation DisordersSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Thierry Passeron, PhD

    CHU de Nice, Service de Dermatologie

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 4, 2021

First Posted

November 15, 2021

Study Start

November 30, 2021

Primary Completion

September 16, 2022

Study Completion

December 15, 2022

Last Updated

March 24, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)