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

Melanosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00863278
• Other study ID #: 08-PP-13
• Status: Terminated
• Phase: Phase 4
• First received: March 16, 2009
• Last updated: March 23, 2012
• Start date: March 2009
• Est. completion date: December 2010

Study information

• Verified date: June 2009
• Source: Centre Hospitalier Universitaire de Nice
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 20
• Est. completion date: December 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Melanosis

Intervention

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.

Locations

Country	Name	City	State
France	CHU de Nice - 4 avenue Reine Victoria - Hôpital de Cimiez	Nice	Alpes-Maritimes

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nice

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No