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

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier:
NCT00863278
First received: March 16, 2009
Last updated: March 23, 2012
Last verified: June 2009
  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 4

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 ]

Enrollment: 20
Study Start Date: March 2009
Study Completion Date: December 2010
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.

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
France
CHU de Nice - 4 avenue Reine Victoria - Hôpital de Cimiez
Nice, Alpes-Maritimes, France, 06001
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: Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier: NCT00863278     History of Changes
Other Study ID Numbers: 08-PP-13
Study First Received: March 16, 2009
Last Updated: March 23, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Melanosis
Hyperpigmentation
Pigmentation Disorders
Skin Diseases

ClinicalTrials.gov processed this record on August 28, 2014