Melasma Clinical Trial - Fractional Photothermolysis for Treating Melasma

Status Completed

Clinical Trial 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).

Clinical Trial Description

n/a

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Melasma

Clinical Trial Details

NCT number	NCT01245881
Study type	Interventional
Source	Laserklinik Karlsruhe
Contact
Status	Completed
Phase	N/A
Start date	March 2008
Completion date	December 2009

View Details

See also
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