Fractional Photothermolysis for Treating Melasma

Study Overview
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Brief Summary
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In several observational studies, non-ablative fractional photothermolysis (FP) has been reported to bridge the gap between efficacy and tolerability in the treatment of melasma. While some beneficial effects have been attributed to non-ablative FP in treating melasma, methodological constraints (e.g., a limited number of patients; no control group assignment) impair efficacy assessment; currently published results neither allow researchers and clinicians to draw valid conclusions nor warrant recommendations for therapy. In particular, bias resulting from poorly designed trials may mislead clinicians into making a wrong decision and generate not only unnecessary treatment (i.e., costs), but also a risk of side effects for patients. Therefore, the purpose of this trial was to clarify the efficacy and safety of FP in the treatment of melasma as compared to the lone application of a sun-blocking lotion (SPF >50).

Official Title
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A Multicenter Study of Fractional Photothermolysis in the Treatment of Melasma

Conditions
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Melasma

Intervention / Treatment
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* Device: Non-ablative fractional photothermolysis laser
* Other: broad-spectrum sunblock (SPF 50+)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults (female/male) with clinical evidence of melasma; Fitzpatrick skin phototype I-III; Ability and willingness to comply with the requirements of the protocol. Exclusion Criteria: Pregnancy or nursing; Inability to avoid sun exposure for occupational reasons (e.g., gardeners); Known history or clinically relevant allergy to components of the sunscreen or topical anaesthetic; Use of topical retinoids within 3 months prior to study enrolment; Use of topical hydroquinone within 6 months prior to study enrolment; Use of topical corticosteroids within 1 month prior to study enrolment; Use of topical cosmetic depigmenting agents within 2 weeks prior to study enrolment; Laser surgery procedures within the treatment region during the last 12 weeks prior to enrolment; Coagulation disorders or anticoagulant treatment; Photo-sensitizing medication (e.g., tetracyclines, gold).
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment group<br>Broad-spectrum UV block plus non-ablative 1,550-nm fractional treatment | Device: Non-ablative fractional photothermolysis laser<br>* Wavelength: 1,550 nm; Energy: 15 mJ/MTZ; Total coverage: 20%; Total density: 1,048 MTZs/cm2; Density per pass: 131 MTZ/cm2; Number of passes: 8.<br>|
| Active Comparator: Control group<br> | Other: broad-spectrum sunblock (SPF 50+)<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in Melasma Area and Severity Index (MASI) at 12 weeks after final treatment |  | Pre-treatment and at final follow-up (12 weeks after last treatment session) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective assessment of treatment outcome (by patients) |  | Pre-treatment and at final follow-up | 
| Patient satisfaction |  | Pre-treatment and at final follow-up | 
| Side effects |  | At each follow-up visit (week 3, 6, 9, 12) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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controlled trial, fractional photothermolysis, laser surgery, melasma, pigment disorder