Fractional Photothermolysis for Treating Melasma

A Multicenter Study of Fractional Photothermolysis in the Treatment of Melasma

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01245881

Enrollment

Registered

2010-11-23

Start date

2008-03-31

Completion date

2009-12-31

Last updated

2010-11-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Melasma

Keywords

controlled trial, fractional photothermolysis, laser surgery, melasma, pigment disorder

Brief summary

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).

Interventions

DEVICENon-ablative fractional photothermolysis laser

* 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.

OTHERbroad-spectrum sunblock (SPF 50+)

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Healthy volunteers

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).

Design outcomes

Primary

Measure	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

Measure	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)

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026