NCT01245881

Fractional Photothermolysis for Treating Melasma

A Multicenter Study of Fractional Photothermolysis in the Treatment of Melasma

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 51 (actual)
• Sponsor: Laserklinik Karlsruhe · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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).

Conditions

• Melasma

Interventions

Type	Name	Description
DEVICE	Non-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.
OTHER	broad-spectrum sunblock (SPF 50+)

Timeline

• Start date: 2008-03-01
• Primary completion: 2009-09-01
• Completion: 2009-12-01
• First posted: 2010-11-23
• Last updated: 2010-11-23

Locations

1 site across 1 country: Germany