Comparative Study of Dual Yellow Laser Versus Stabilized Kilnman Preparation in the Treatment of Melasma
Condition: Melasma
MeSH terms: Melanosis
Study type: Interventional

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 will be
           offered to patients corresponding to the selection criteria of the study.

        2. Visit V0: Inclusion and early treatment After a minimum of 15 days, patients will begin
           the study. This will ensure that patients signed informed consent. An initial clinical
           evaluation of melasma with calculation of MASI score and standardized photographs (see
           chapter 'assessment') will be made. An examination by confocal microscopy in vivo will
           be realized. All patients will receive treatment by stabilized kilnman trio for four
           weeks.

           In the week prior to Visit 1, the side of the face to receive the laser treatment will
           be determined by randomisation.

        3. Visit V1: (Week 4) Clinical evaluation of melasma with calculation of MASI score and
           photographs will be made. Possible side effects (including PPI) will be noted.

           The next trio will be treated with depigmenting kilnman trio for another 8 weeks. The
           contralateral side will receive its first laser session. Given the results of analysis
           by intention to treat, the occurrence of serious side effects will result in
           discontinuation of treatment but monitoring will continue with the assessments.

        4. Visit V2: (week 6) Clinical evaluation of melasma with calculation of MASI score and
           photographs will be made. Possible side effects (including PPI) will be noted.

           The laser side will receive its second session. Patients continue the applications of
           cream on the contralateral side.

        5. Visit V3 (week 9) Clinical evaluation of melasma with calculation of MASI score and
           photographs will be made. Possible side effects (including PPI) will be noted.

           The laser side will receive its third session.Patients continue the applications of
           cream on the contralateral side.

        6. Visit V4 (week 12) Clinical evaluation of melasma with calculation of MASI score and
           photographs will be made. Possible side effects (including PPI) will be noted.

           The laser side will receive its fourth and final session. Patients continue the
           applications of cream on the contralateral side during 4 weeks.

        7. Visit V5: (week 18) Clinical evaluation of melasma with calculation of MASI score and
           photographs will be made. Possible side effects (including PPI) will be noted. An
           assessment by in vivo confocal laser will be realized.

        8. Visit V6: (week 24) Clinical evaluation of melasma with calculation of MASI score and
           photographs will be made. Possible side effects (including PPI) will be noted. An
           assessment by in vivo confocal laser will be realized.

        9. Visit V7 (final week 36):

      Clinical evaluation of melasma with calculation of MASI score and photographs will be made.
      Possible side effects (including PPI) will be noted. An assessment by in vivo confocal laser
      will be realized. The evaluation of safety and patient satisfaction will be performed using a
      visual analog scale.

      The primary endpoint will be the MASI score, score approved for assessment of melasma
      treatments.
    


Intervention name(s): Dual yellow Laser; Stabilized kilnman trio
Intervention type(s): Device; Drug
Intervention description(s): Patients will receive treatment by stabilized kilnman trio for four weeks (one application per day). Patient will receive 4 treatments by Dual yellow Laser on the hemi-face (side determinated by randomisation, split body study) at weeks 4, 6, 9 and 12.; The stabilized kilnman trio will be prescribed for one month at inclusion (all over the face, one application per day), and on the half of the face not treated by laser at weeks 4, 8 and 12 (one application per day).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment