Fractional Photothermolysis for Treating Melasma

Not Applicable

Completed

• Conditions: Melasma
• Interventions: Device: Non-ablative fractional photothermolysis laser; Other: broad-spectrum sunblock (SPF 50+)

• Registration Number: NCT01245881
• Lead Sponsor: Laserklinik Karlsruhe

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2008-03
• Primary Completion: 2009-09
• Study Completion: 2009-12
• Status Verified: 2010-11
• Study First Submitted: 2010-11-19
• Study First Submitted QC: 2010-11-22
• Last Update Submitted: 2010-11-22
• Study First Posted: 2010-11-23
• Last Update Posted: 2010-11-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 51

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment group	Non-ablative fractional photothermolysis laser	Broad-spectrum UV block plus non-ablative 1,550-nm fractional treatment
Control group	broad-spectrum sunblock (SPF 50+)	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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)

Trial Locations

Locations (1)

Laserklinik Karlsruhe; 🇩🇪 Karlsruhe, Germany