MedTrace Logo

Fractional Photothermolysis for Treating Melasma

NCT01245881 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 51

Last updated 2010-11-23

No results posted yet for this study

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

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+)

Sponsors & Collaborators

  • Laser and Skin Centre Potsdam, Potsdam, Germany

    collaborator UNKNOWN

  • Laserklinik Karlsruhe

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-03-31
Primary Completion
2009-09-30
Completion
2009-12-31

Countries

  • Germany

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01245881 on ClinicalTrials.gov