Clinical trial NCT01850186: Comparative Study of Dual Yellow Laser Versus Stabilized Kilnman Preparation in the Treatment of Melasma
Official title: Comparative Study of Dual Yellow Laser Versus Stabilized Kilnman Preparation in the Treatment of Melasma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Melasma
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2013-05-09
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.


Eligibility criteria: Inclusion Criteria:

* Inclusion criteria
* Age ≥ 18 years, ≤75 years.
* Clinical diagnosis of melasma
* Fitzpatrick phototype 1 to 4.
* Effective contraception will be maintained for the duration of the study.
* Affiliation to the Social Security
* Informed consent signed by the patient

Exclusion Criteria:

* Pregnant or breastfeeding women; effective contraception will be maintained for the duration of the study.
* Fitzpatrick phototype ≥ 5
* Intolerance or allergy to compounds of
* Exposure to UV or concomitant exposure to the sun without 50+ protective shield.
* Concomitant topical treatments may be effective on melasma (topical corticosteroids, topical retinoids)

Primary outcomes:
measure: Scoring systems in dermatology
timeFrame: 36 weeks
Secondary outcomes:
measure: Tolerance and sever adverse event
timeFrame: 36 weeks
Other outcomes:
Locations:
city: Nice
country: France
facility: CHU de Nice - Hôpital Archet
state: Alpes-Maritimes
Study officials:
affiliation: CHU de Nice - Hôpital de l'Archet - Dermatology
name: PASSERON Thierry, PU-PH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hammami Ghorbel H, Boukari F, Fontas E, Montaudie H, Bahadoran P, Lacour JP, Passeron T. Copper Bromide Laser vs Triple-Combination Cream for the Treatment of Melasma: A Randomized Clinical Trial. JAMA Dermatol. 2015 Jul;151(7):791-2. doi: 10.1001/jamadermatol.2014.5580. No abstract available.