Treatment of Melasma With Stabilized Kligman Preparation Associated or Not With Pulsed Dye Laser

• Status: Terminated
• Trial end date: 2010-12-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Centre Hospitalier Universitaire de Nice

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…)