An interventional study of Dual yellow Laser and Stabilized kilnman trio in Melasma, sponsored by Centre Hospitalier Universitaire de Nice. Completed at 1 site in France. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2015-02-16.
Sponsored by Centre Hospitalier Universitaire de Nice · Not applicable, Interventional, and Treatment
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
Methods Monocentric prospective interventional randomized split face comparative study between experimental treatment versus reference treatment.
Intervention
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.
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.
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.
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.
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.
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.
149 studies on the registry are indexed under Melanosis; 38 are open to participants now.
This study's enrollment of 20 is below the median of 40 across 139 interventional studies indexed under Melanosis.
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Inclusion Criteria:
Exclusion Criteria:
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.
Device: Dual yellow Laser
Patients will receive treatment by stabilized kilnman trio for four weeks on all the face (one application per day). At the beginning of week 5, Patient will receive stabilized kilnman trio on the hemi-face during three months (side not treated by dual yellow laser, split body study). The stabilized kilnman trio will be prescribed for one month at inclusion (applied all over the face), and on the half of the face not treated by laser at weeks 4, 8 and 12.
Drug: Stabilized kilnman trio
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).
Scoring systems in dermatology
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).
Time frame: 36 weeks
Tolerance and sever adverse event
* 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).
Time frame: 36 weeks
This study is completed, as verified in Feb 2015. You cannot join it, but the record below documents what was studied.
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Centre Hospitalier Universitaire de Nice