Melanosis
Conditions
Brief summary
Melasma is an acquired disorder of pigmentation that leads to irregular pigmented patches on the face. Treatment is difficult and to date the best treatment option is the combination of hydroquinone, retinoic acid and steroids combined in topical daily application (called Kligman's trio). Q-switched pigmentary lasers are usually ineffective and can induce post inflammatory hyperpigmentation (PIH). Intense pulsed light can sometimes improve melasma but also induce PIH which limit their use. Recently, pulsed dye laser were demonstrated to be effective in treating some pigmentary defects. Associating blanching cream with hydroquinone to prevent PIH after laser or intense pulsed light has been already reported with success. The objective of the study is to compare in a prospective intra individual comparative trial the association of pulsed dye laser plus stabilized Kligman's trio to Kligman's trio alone. The secondary objective was to study the frequency and the intensity of the potential side effects including PIH.
Interventions
PROCEDUREpulsed dye laser treatment
On one side of the face according to Arm placement.
DRUGKligman's Trio
The combination of hydroquinone, retinoic acid and steroids combined in topical daily application.
Sponsors
Centre Hospitalier Universitaire de Nice
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Pregnant women or breastfeeding. * Skin type 5 or 6.
Exclusion criteria
* Known allergy to the compounds of the Kligman preparation. * Refusal to put very high protection sunscreen during the study. * Concomitant use of topical products that might have an effect on melasma (topical steroids, retinoids, etc…)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| MASI score, standardized photos in direct, crossed polarized and UV light, relating to the security: 0 yes 1 N0 | visit of screening (V0), 15 days after V0 during the follow visit 1(V1), 3 weeks after V1 during the following visit 2(V2), 3 weeks after V2 during the following visit 3(V3), 10 weeks after V3 during the following visit 4 |
Secondary
| Measure | Time frame |
|---|---|
| Clinical evaluation of potential side-effects (including post inflammatory pigmentation) | visit of screening (V0), 15 days after V0 during the follow visit 1(V1), 3 weeks after V1 during the following visit 2(V2), 3 weeks after V2 during the following visit 3(V3), 10 weeks after V3 during the following visit 4 |
Countries
France
Outcome results
None listed