Treatment of Melasma With Stabilized Kligman Preparation Associated or Not With Pulsed Dye Laser - Full Text View

Sponsor:	Centre Hospitalier Universitaire de Nice
Information provided by:	Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier:	NCT00863278

Purpose

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.

Condition	Intervention	Phase
Melanosis	Procedure: pulsed dye laser treatment Drug: Kligman's Trio	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Treatment of Melasma With Stabilized Kligman Preparation Associated or Not With Pulsed Dye Laser; a Comparative Prospective Study

Further study details as provided by Centre Hospitalier Universitaire de Nice:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Estimated Enrollment:	24
Study Start Date:	March 2009
Estimated Study Completion Date:	March 2010
Estimated Primary Completion Date:	March 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.

Arms

Assigned Interventions

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.

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

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…)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00863278

Contacts

Contact: PASSERON Ph Thierry, MD

+33492036223

passeron.t@chu-nice.fr

Locations

France
CHU de Nice - 4 avenue Reine Victoria - Hôpital de Cimiez	Recruiting
Nice, Alpes-Maritimes, France, 06001
Contact: PASSERON Thierry, MD +33492036223 passeron.t@chu-nice.fr

Sponsors and Collaborators

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

More Information

No publications provided

Responsible Party:	CAILLON Cynthia, CHU de Nice
ClinicalTrials.gov Identifier:	NCT00863278 History of Changes
Other Study ID Numbers:	08-PP-13
Study First Received:	March 16, 2009
Last Updated:	June 8, 2009
Health Authority:	France: Afssaps - French Health Products Safety Agency

Additional relevant MeSH terms:

Melanosis
Hyperpigmentation
Pigmentation Disorders
Skin Diseases

ClinicalTrials.gov processed this record on February 09, 2012