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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00863278
Other study ID # 08-PP-13
Secondary ID
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


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
See also
  Status Clinical Trial Phase
Completed NCT01976273 - A Pilot Study Testing 1064nm Q-switch Laser Versus Glycolic Acid Peels for the Treatment of Melasma N/A
Completed NCT05119413 - Comparison of a New Masterful Preparation to Kligman's Trio in the Treatment of Melasma Phase 2
Recruiting NCT00927771 - Azelaic Acid Versus Hydroquinone in Melasma Phase 4
Not yet recruiting NCT05930366 - Comparative Evaluation of Microsurgery vs Diode Laser Technique of Gingival Depigmentation N/A
Not yet recruiting NCT05930392 - Comparative Evaluation of Microsurgery vs Conventional Surgical Technique of Gingival Depigmentation N/A
Active, not recruiting NCT01976286 - A Pilot Study Testing Salicylic Acid Peels Versus Glycolic Acid Peels for the Treatment of Melasma N/A
Not yet recruiting NCT03585179 - Oral and Topical Tranexamic Acid for the Treatment of Melasma Phase 3