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

Centre Hospitalier Universitaire de Nice

Status and phase: Completed; Phase 2

Conditions: Melanosis

Treatments: Drug: New trio de Kligman; Drug: Trio Kligman

Study type: Interventional

Funder types: Other

Identifiers

NCT05119413

20-PP-30

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 2 patient groups

New traitement

Experimental group

Description:

Thiamidol, retinoid, topical steroid preparation

Treatment:

Drug: New trio de Kligman

Kligman's trio

Other group

Description:

Application once a day for 12 weeks

Treatment:

Drug: Trio Kligman