The primary objective of this study is to assess the efficacy and safety of non ablative and ablative fractional lasers in various pigment disorders.
ID
Source
Brief title
Condition
- Pigmentation disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Objective colour measurements by physician*s global assessment (PhGA),
reflectance spectroscopy, clinical melasma score (MASI), patient*s
satisfaction, patient*s global assessment (PGA), and visual assessment of side
effects.
Secondary outcome
-
Background summary
Local bleaching is the first choice for the treatment of melasma,
postinflammatory hyperpigmentation, Q-switched ruby laser is the first choice
for the treatment of Resistant Ota naevus. However, the outcome is highly
variable and there is a substantial part of patients with a poor result. No
treatment options are available for Becker naevus, ochronosis, and ashy
dermatosis. Recently non ablative fractional laser (such as the Starlux 1540 nm
laser (PALOMAR) or FRAXEL RE:STORE 1550 nm laser (RELIANT)) and ablative
fractional laser (such as LUMINUS encore fractional CO2 laser (LUMINUS) or
FRAXEL RE:PAIR laser (RELIANT)) were suggested to be effective in the treatment
of hyperpigmented disorders.
According to our previous experience the non ablative fractional laser appeared
to be a safe and effective treatment option as compared to local bleaching
(triple therapy) in 22 patients with moderate to severe melasma (publication
in preparation).
Study objective
The primary objective of this study is to assess the efficacy and safety of non
ablative and ablative fractional lasers in various pigment disorders.
Study design
Prospective single blinded randomised controlled split-lesion trial
Intervention
fractional laser therapy every 3-6 weeks with a maximum of 5 treatments
dependant on skin type and disorder
Study burden and risks
Subjects participating in the study will be asked to visit the SNIP 3-7 times
depending on disorder and skin type. The time investment will be 40 minutes for
visits with a laser treatment and 20 minutes for all follow up visits. No
invasive procedures will be performed. The objective colour measurement
involves a handheld device producing a harmless flash of light. The laser
procedure is moderately painful which makes the local application of lidocain
cream 2 hours before treatment necessary. Known side effects of the laser
procedure are local stinging, burning and erythema for several hours or days.
Side effects of our standard topical bleaching, the triple therapy, may be
perioral dermatitis, exacerbation of acne, telangiectasia, local irritation and
hyperpigmentation.
All together the burden due to the study is moderate and the risk for local
side effects is low. Systemic side effects are not associated with any of the
involved treatments.
Meibergdreef 35
1105AZ, Amsterdam
Nederland
Meibergdreef 35
1105AZ, Amsterdam
Nederland
Listed location countries
Age
Inclusion criteria
Melasma and postinflammatory hyperpigmentation : skin photo type I-V ;
Becker naevus: skin photo type I-III ;
Ochronosis and ashy dermatosis : skin photo type IV-V ;
resistant Ota naevus: skin photo type III-IV ;
Subjects attending the outpatient department of the Netherlands Institute for Pigment Disorders;
Age at least 18 years;
Subject is willing and able to give written informed consent.
Exclusion criteria
Bleaching cream during the past 6 weeks;
Local corticosteroids during the past 6 weeks;
Subjects with a history of keloid;
Subjects with active eczema;
Subjects with active acne in the face;
Subjects with a history of facial eczema;
Suspect allergy to lidocaine or triple therapy;
Use of roaccutane in the past 6 months;
Subjects not competent to understand what is involved;
Pregnancy;
Lesion suspicious for malignancy;
High exposure to sunlight (vacation in southern countries) or UV light (UVA or UVB).
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 |
|---|---|
| CCMO | NL26170.018.08 |