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

NCT01850186 | Completed

• 1 other identifier: 11-PP-15
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• Visit V7 (final week 36):

Conditions

Melasma

Outcome Measures

Primary Outcomes (1)

• 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).

  36 weeks

Secondary Outcomes (1)

• Tolerance and sever adverse event

  36 weeks

Study Arms (2)

Dual yellow Laser

EXPERIMENTAL

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

Stabilized kilnman trio

PLACEBO COMPARATOR

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

Interventions

Dual yellow Laser DEVICE

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.

Dual yellow Laser

Stabilized kilnman trio DRUG

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).

Stabilized kilnman trio

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice: lead

Study Sites (1)

CHU de Nice - Hôpital Archet

Nice, Alpes-Maritimes, 06, France

Location

Related Publications (1)

• 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.

  PMID: 25715311 DERIVED

MeSH Terms

Conditions

Melanosis

Condition Hierarchy (Ancestors)

Hyperpigmentation; Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• PASSERON Thierry, PU-PH

  CHU de Nice - Hôpital de l'Archet - Dermatology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2013
• First Posted: May 9, 2013
• Study Start: February 1, 2012
• Primary Completion: June 1, 2013
• Study Completion: September 1, 2013
• Last Updated: February 16, 2015

Record last verified: 2015-02

Locations

FR (1)