The primary objective of this study is to assess the efficacyand safety of the fraxel laser as compared to a potent bleaching cream (triple therapy) in the treatment of melasma.
ID
Source
Brief title
Condition
- Pigmentation disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Objective colour measurements by reflectance spectroscopy before and after
therapy
Clinical melasma score (MASI score) before and after therapy
Secondary outcome
Quality of life
Patient's satisfaction
Background summary
Local bleaching is the first choice for the treatment of melasma. However, the
outcome is highly variable and there is a substantial part of patients with a
poor result of the bleaching treatment. The triple therapy is the first choice
for the treatment of melasma. Especially patients with dermal melasma are known
to be resistant to any kind of local treatment. Recently fractional
photothermolysis was suggested to be effective in the treatment of melasma.
Study objective
The primary objective of this study is to assess the efficacy
and safety of the fraxel laser as compared to a potent bleaching cream (triple
therapy) in the treatment of melasma.
Study design
Prospective randomised controlled single blinded parallel group pilot study
Intervention
Triple therapy
Triple therapy will be applied once daily for 8 weeks. The triple therapy
combines a moderately potent corticosteroid (triamcinolon acetonide 0.1%),
retinoic acid 0.05% and hydrochinon 5% in cremor lanette II. This cream is
applied once a day in the evening on all hyperpigmented macules.
Fraxel laser
One hour before laser treatment patients will apply a topical anaesthetic cream
(EMLA cream). Then the skin will be washed with cleanser. Then the skin will be
prepared with 70% alcohol. One treatment consists of eight passes with the
device to create a final treatment density of 2000 microthermal treatment zones
(MTZ) per cm2. Four passes are made in one direction and four passes are made
in a perpendicular direction. The average fluence (radiant exposure) per pass
is 2-3 J/cm2, and total treatment fluence (radiant exposure) will be 20 J/cm².
Subsequent laser treatments are provided at 2 week intervals, and all subjects
will receive a total of 4 laser treatments.
All subjects will be advised to use topical sun protection (SPF>50).
Study burden and risks
The risk for irreversible side effects is very low for both intervention. The
triple therapy is the first choice of treatment worlwide. It is used routinely
since more than 10 years at our institute. We sometimes see mild local skin
irritation which disappears spontaneously after stopping the medication.
The fractional photothermolysis used in the present study is the Fraxel laser
which has FDA approval for the treatment of melasma. the laser treatment is
moderately painful. Both treatment can lead to erythema, burning sensation,
vesicles, hyperpigmentation or hypopigmentation. Often we see swelling of the
treated skin directly after laser treatment. Scras have not been reported by
any of the two treatments.
Participants need to visit our institute regularly for treatment and follow-up
visits. There are no invasive procedures.
Meibergdreef 35
1105 AZ Amsterdam
Nederland
Meibergdreef 35
1105 AZ Amsterdam
Nederland
Listed location countries
Age
Inclusion criteria
- patiënts with moderate to severe melasma
- skin photo type II-V
- subjects attending the outpatient department of the Netherlands Institute for Pigment Disorders
- age at least 18 years
Exclusion criteria
- bleaching cream or local corticosteroids during the past 4 weeks
- subjects with a history of keloid
- subjects with a history of facial eczema
- allergy to lidocaine
- use of roaccutane in the past 6 month
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| Other | CCT-NAPN-16718 |
| CCMO | NL18605.018.07 |