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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2013 by Centre Hospitalier Universitaire de Nice
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier:
NCT01850186
First received: April 23, 2013
Last updated: May 7, 2013
Last verified: May 2013
  Purpose

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.


Condition Intervention
Melasma
Device: Dual yellow Laser
Drug: Stabilized kilnman trio

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Comparative Study of Dual Yellow Laser Versus Stabilized Kilnman Preparation in the Treatment of Melasma

Further study details as provided by Centre Hospitalier Universitaire de Nice:

Primary Outcome Measures:
  • Scoring systems in dermatology [ Time Frame: 36 weeks ] [ Designated as safety issue: No ]

    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).



Secondary Outcome Measures:
  • Tolerance and sever adverse event [ Time Frame: 36 weeks ] [ Designated as safety issue: No ]
    • 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).


Estimated Enrollment: 20
Study Start Date: February 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dual yellow Laser
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 (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.
Placebo Comparator: Stabilized kilnman trio
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
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).

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01850186

Contacts
Contact: PASSERON Thierry, PU-PH passeron.t@chu-nice.fr

Locations
France
CHU de Nice - Hôpital Archet Recruiting
Nice, Alpes-Maritimes, France, 06
Contact: PASSERON Thierry, PU-PH       passeron.t@chu-nice.fr   
Principal Investigator: PASSERON Thierry, PU-PH         
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nice
Investigators
Principal Investigator: PASSERON Thierry, PU-PH CHU de Nice - Hôpital de l'Archet - Dermatology
  More Information

No publications provided

Responsible Party: Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier: NCT01850186     History of Changes
Other Study ID Numbers: 11-PP-15
Study First Received: April 23, 2013
Last Updated: May 7, 2013
Health Authority: France: Committee for the Protection of Personnes
France: Agence Nationale de Sécurité du Médicament et des produits de santé

Additional relevant MeSH terms:
Melanosis
Hyperpigmentation
Pigmentation Disorders
Skin Diseases

ClinicalTrials.gov processed this record on August 28, 2014