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

Centre Hospitalier Universitaire de Nice

Status and phase: Terminated; Phase 4

Conditions: Melanosis

Treatments: Drug: Kligman's Trio; Procedure: pulsed dye laser treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT00863278

08-PP-13

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: Female

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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...)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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20 participants in 2 patient groups

Arm A

Active Comparator group

Description:

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.

Treatment:

Drug: Kligman's Trio

Procedure: pulsed dye laser treatment

Arm B

Active Comparator group

Description:

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.

Treatment:

Drug: Kligman's Trio

Procedure: pulsed dye laser treatment