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

C

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

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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