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

Primary Purpose

Melanosis

Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
New trio de Kligman
Trio Kligman
Sponsored by
Centre Hospitalier Universitaire de Nice
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Melanosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHU de Nice

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

New traitement

Kligman's trio

Arm Description

Thiamidol, retinoid, topical steroid preparation

Application once a day for 12 weeks

Outcomes

Primary Outcome Measures

The melasma's type
Clinical score MASI

Secondary Outcome Measures

the Quality of life of patient
descriptive name of scale : meslascol

Full Information

First Posted
October 4, 2021
Last Updated
January 26, 2023
Sponsor
Centre Hospitalier Universitaire de Nice
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1. Study Identification

Unique Protocol Identification Number
NCT05119413
Brief Title
Comparison of a New Masterful Preparation to Kligman's Trio in the Treatment of Melasma
Acronym
Kligman
Official Title
Comparison of a New Masterful Preparation to Kligman's Trio in the Treatment of Melasma: a Double Blind Prospective Randomzed Study
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
November 30, 2021 (Actual)
Primary Completion Date
September 16, 2022 (Actual)
Study Completion Date
December 15, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nice

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Melanosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
New traitement
Arm Type
Experimental
Arm Description
Thiamidol, retinoid, topical steroid preparation
Arm Title
Kligman's trio
Arm Type
Other
Arm Description
Application once a day for 12 weeks
Intervention Type
Drug
Intervention Name(s)
New trio de Kligman
Intervention Description
Once daily application in addition to the same sunscreen
Intervention Type
Drug
Intervention Name(s)
Trio Kligman
Intervention Description
Once daily application in addition to the same sunscreen
Primary Outcome Measure Information:
Title
The melasma's type
Description
Clinical score MASI
Time Frame
at 12 weeks
Secondary Outcome Measure Information:
Title
the Quality of life of patient
Description
descriptive name of scale : meslascol
Time Frame
at 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: SIGNED WRITTEN CONSENT 1) Melasma clinically diagnosed Exclusion Criteria: Pregnant woman Other pigmentary disorder affecting the face Use of systemic or topical steroids or retinoids, use of topical depigmenting agents or depigmenting procedure in the month before the inclusion
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thierry Passeron, PhD
Organizational Affiliation
CHU de Nice, Service de Dermatologie
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de Nice
City
Nice
State/Province
Alpes-maritimes
ZIP/Postal Code
06200
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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