Clinical Trial: Comparative Study of Dual Yellow Laser Versus Stabilized Kilnman Preparation in the Treatment of Melasma

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Comparative Study of Dual Yellow Laser Versus Stabilized Kilnman Preparation in the Treatment of Melasma

Brief Summary:

Recent data highlight the role of vascularity in melasma and a recent study showed the interest to target this vascular component by pulsed dye laser. The Dual Yellow laser is a copper bromide laser emitting dual wavelength (green 511nm and yellow 578 nm). This laser can target both the vascular and pigmented components of melasma. A preliminary study has shown its efficacy and excellent tolerability in the treatment of melasma. This study requires however to be confirmed by a comparative study versus reference treatment.

Main objective To compare the efficacy on melasma at 6 month post treatment of a Dual Yellow Laser preceded by 1 month of kilnman trio and the kilnman trio monotherapy for 3 months in an intra-patient study.

Secondary objectives

  • To study the frequency of PPI.
  • Compare the rate and extent of recurrence 6 months after completion of treatment.
  • To study the occurrence of possible adverse effects.
  • Compare the effectiveness of Dual Yellow laser to kilnman trio monotherapy at S12 (end of treatment).
  • To study patient satisfaction on the effectiveness and tolerability of the study treatments.

Methods Monocentric prospective interventional randomized split face comparative study between experimental treatment versus reference treatment.

Intervention

  1. Visit Selection Patients will be selected from those presenting to the consultation of the department of dermatology at University Hospital of Nice. Participation wil

    Detailed Summary:
    Sponsor: Centre Hospitalier Universitaire de Nice

    Current Primary Outcome: Scoring systems in dermatology [ Time Frame: 36 weeks ]

    The primary endpoint will be the Scoring systems in dermatology (MASI score), score approved for assessment of melasma treatments compared between inclusion and after 6 month of treatment.

    A blind treatment evaluation of direct light, UV and polarized photographs (VISIA, cornfield ©) between inclusion and after 6 month of treatment will be performed by an independent observer (dermatologist).



    Original Primary Outcome: Same as current

    Current Secondary Outcome: Tolerance and sever adverse event [ Time Frame: 36 weeks ]

    • Effectiveness and tolerance of the patient will be studied using visual analog scales (VAS) graded from 0 to 10.
    • Side effects: frequency, severity and time of occurrence of side effects will be reported for each treatment. Side effects are classified into grades according to WHO criteria.
    • The occurrence of PPI will be sought during the clinical examination at each visit.
    • The concept of relapse will be determined using the MASI score. Will be considered as relapsed patients with MASI score at 6 months returned to baseline or above pretreatment.
    • An examination by confocal microscopy in vivo will evaluate with precision the histological evolution of the lesions treated between inclusion and weeks 18, 24 and 36 (end of study).


    Original Secondary Outcome: Same as current

    Information By: Centre Hospitalier Universitaire de Nice

    Dates:
    Date Received: April 23, 2013
    Date Started: February 2012
    Date Completion:
    Last Updated: February 13, 2015
    Last Verified: February 2015