A Phase 4 interventional study of pulsed dye laser treatment and Kligman's Trio in Melanosis, sponsored by Centre Hospitalier Universitaire de Nice. Terminated at 1 site in France. Open to female participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2012-03-26.
Sponsored by Centre Hospitalier Universitaire de Nice · Phase 4, Interventional, and Treatment
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.
159 studies on the registry are indexed under Melanosis; 42 are open to participants now.
This study's enrollment of 20 is below the median of 40 across 149 interventional studies indexed under Melanosis.
Browse Melanosis studies →Centre Hospitalier Universitaire de Nice is the lead sponsor of 722 studies on the registry; 176 are open to participants now.
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Exclusion Criteria:
All patients will be treated by stabilized Kligman's trio with daily application during 4 months. After one month, the left side of the face will be treated with pulsed dye laser at the rate of 3 sessions (one every weeks). Applications of cream will be stopped on both side of the face for the 3 days following each laser session. Final visit will be scheduled 1 month after the end of applications of stabilized Kligman's trio. All the patients will used a sunscreen indication 50 + for the duration of the entire study. The patient is her own witness. They compare the hemiface treated without laser and the hemiface treated with the laser.
Procedure: pulsed dye laser treatment · Drug: Kligman's Trio
All patients will be treated by stabilized Kligman's trio at the rate of application in the evening during 4 months. After one month, the side of the right face will be treated by pulsed dye laser at the rase of 3 sessions spaced out by 3 weeks each. Applications will be stopped in the 3 days which will follow every session by laser with blown colouring agent. The patients will be seen again 1 month after the stopping of applications of stabilized Kligman's trio All patients will be used a sunscreen indication 50 + for the duration of study. The patient is her own witness. They compare the cheek treated without laser and the cheek treated with the laser.
Procedure: pulsed dye laser treatment · Drug: Kligman's Trio
On one side of the face according to Arm placement.
The combination of hydroquinone, retinoic acid and steroids combined in topical daily application.
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
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
The record gives a start of Mar 2009, a primary completion of Mar 2010 and a completion of Dec 2010. It does not say whether these dates are actual or estimated.
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This study is terminated, as verified in Jun 2009. You cannot join it, but the record below documents what was studied.
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