Treatment of Melasma With Stabilized Kligman Preparation Associated or Not With Pulsed Dye Laser
Information source: Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Melanosis
Intervention: pulsed dye laser treatment (Procedure); Kligman's Trio (Drug)
Phase: Phase 4
Status: Terminated
Sponsored by: Centre Hospitalier Universitaire de Nice Official(s) and/or principal investigator(s): PASSERON Ph Thierry, MD, Principal Investigator, Affiliation: CHU de Nice - Service de Dermatologie - Hôpital de l'Archet - 151 Route de saint-antoine de ginestière 06200 Nice
Summary
Melasma is an acquired disorder of pigmentation that leads to irregular pigmented patches on
the face. Treatment is difficult and to date the best treatment option is the combination of
hydroquinone, retinoic acid and steroids combined in topical daily application (called
Kligman's trio). Q-switched pigmentary lasers are usually ineffective and can induce post
inflammatory hyperpigmentation (PIH). Intense pulsed light can sometimes improve melasma but
also induce PIH which limit their use. Recently, pulsed dye laser were demonstrated to be
effective in treating some pigmentary defects. Associating blanching cream with hydroquinone
to prevent PIH after laser or intense pulsed light has been already reported with success.
The objective of the study is to compare in a prospective intra individual comparative trial
the association of pulsed dye laser plus stabilized Kligman's trio to Kligman's trio alone.
The secondary objective was to study the frequency and the intensity of the potential side
effects including PIH.
Clinical Details
Official title: Treatment of Melasma With Stabilized Kligman Preparation Associated or Not With Pulsed Dye Laser; a Comparative Prospective Study
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: MASI score, standardized photos in direct, crossed polarized and UV light, relating to the security: 0 yes 1 N0
Secondary outcome: Clinical evaluation of potential side-effects (including post inflammatory pigmentation)
Eligibility
Minimum age: 18 Years.
Maximum age: 75 Years.
Gender(s): Female.
Criteria:
Inclusion Criteria:
- Pregnant women or breastfeeding.
- Skin type 5 or 6.
Exclusion Criteria:
- Known allergy to the compounds of the Kligman preparation.
- Refusal to put very high protection sunscreen during the study.
- Concomitant use of topical products that might have an effect on melasma (topical
steroids, retinoids, etc…)
Locations and Contacts
CHU de Nice - 4 avenue Reine Victoria - Hôpital de Cimiez, Nice, Alpes-Maritimes 06001, France
Additional Information
Starting date: March 2009
Last updated: March 23, 2012
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