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

Melanosis Clinical Trial

— Kligman  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05119413
• Other study ID #: 20-PP-30
• Status: Completed
• Phase: Phase 2
• Start date: November 30, 2021
• Est. completion date: December 15, 2022

Study information

• Verified date: January 2023
• Source: Centre Hospitalier Universitaire de Nice
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 15, 2022
• Est. primary completion date: September 16, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Melanosis

Intervention

Drug:
• New trio de Kligman
Once daily application in addition to the same sunscreen
• Trio Kligman
Once daily application in addition to the same sunscreen

Locations

Country	Name	City	State
France	CHU de Nice	Nice	Alpes-maritimes

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nice

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The melasma's type	Clinical score MASI	at 12 weeks
Secondary	the Quality of life of patient	descriptive name of scale : meslascol	at 12 weeks