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

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: Treatment of Melasma With Stabilized Kligman Preparation Associated or Not With Pulsed Dye Laser; a Comparative Prospective Study

Brief 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.

Detailed Summary:
Sponsor: Centre Hospitalier Universitaire de Nice

Current Primary Outcome: MASI score, standardized photos in direct, crossed polarized and UV light, relating to the security: 0 yes 1 N0 [ Time Frame: visit of screening (V0), 15 days after V0 during the follow visit 1(V1), 3 weeks after V1 during the following visit 2(V2), 3 weeks after V2 during the following visit 3(V3), 10 weeks after V3 during the following visit 4 ]

Original Primary Outcome: • MASI score • Standardized photos in direct, crossed polarized and UV light • relating to the security : 0 yes 1 N0 [ Time Frame: visit of screening (V0), 15 days after V0 during the follow visit 1(V1), 3 weeks after V1 during the following visit 2(V2), 3 weeks after V2 during the following visit 3(V3), 10 weeks after V3 during the following visit 4 ]

Current Secondary Outcome: Clinical evaluation of potential side-effects (including post inflammatory pigmentation) [ Time Frame: visit of screening (V0), 15 days after V0 during the follow visit 1(V1), 3 weeks after V1 during the following visit 2(V2), 3 weeks after V2 during the following visit 3(V3), 10 weeks after V3 during the following visit 4 ]

Original Secondary Outcome: Same as current

Information By: Centre Hospitalier Universitaire de Nice

Dates:
Date Received: March 16, 2009
Date Started: March 2009
Date Completion:
Last Updated: March 23, 2012
Last Verified: June 2009