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

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

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.

Study Overview

• Status: Terminated
• Conditions: Melanosis
• Intervention / Treatment: Procedure: pulsed dye laser treatment; Drug: Kligman's Trio

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 4

Contacts and Locations

Study Locations

• France
  • Alpes-Maritimes
    • Nice, Alpes-Maritimes, France, 06001
      • CHU de Nice - 4 avenue Reine Victoria - Hôpital de Cimiez

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 73 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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…)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Arm A; 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; On one side of the face according to Arm placement.; Drug: Kligman's Trio; The combination of hydroquinone, retinoic acid and steroids combined in topical daily application.
Active Comparator: Arm B; 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; On one side of the face according to Arm placement.; Drug: Kligman's Trio; The combination of hydroquinone, retinoic acid and steroids combined in topical daily application.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
MASI score, standardized photos in direct, crossed polarized and UV light, relating to the security: 0 yes 1 N0	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

Secondary Outcome Measures

Outcome Measure	Time Frame
Clinical evaluation of potential side-effects (including post inflammatory pigmentation)	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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nice
• Investigators: Principal Investigator: PASSERON Ph Thierry, Md, CHU de Nice - Service de Dermatologie - Hôpital de l'Archet - 151 Route de saint-antoine de ginestière 06200 Nice

Study record dates

Study Major Dates

• Study Start: March 1, 2009
• Primary Completion (Actual): March 1, 2010
• Study Completion (Actual): December 1, 2010

Study Registration Dates

• First Submitted: March 16, 2009
• First Submitted That Met QC Criteria: March 16, 2009
• First Posted (Estimate): March 17, 2009

Study Record Updates

• Last Update Posted (Estimate): March 26, 2012
• Last Update Submitted That Met QC Criteria: March 23, 2012
• Last Verified: June 1, 2009

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Hyperpigmentation; Pigmentation Disorders; Melanosis
• Other Study ID Numbers: 08-PP-13