Skip to main content
OpenTrials
Completed

NCT Number: NCT01245881

Fractional Photothermolysis for Treating Melasma

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Melasma Hyperpigmentation Melanosis Pathologic Processes Pathological Conditions, Signs and Symptoms Pigmentation Disorders Skin Diseases Skin and Connective Tissue Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Laserklinik Karlsruhe

Karlsruhe, 76133, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Non-ablative fractional photothermolysis laser

Device
  • 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.

broad-spectrum sunblock (SPF 50+)

Other

Primary outcomes

  1. Change from Baseline in Melasma Area and Severity Index (MASI) at 12 weeks after final treatment

    Time frame: Pre-treatment and at final follow-up (12 weeks after last treatment session)

Secondary outcomes

  1. Subjective assessment of treatment outcome (by patients)

    Time frame: Pre-treatment and at final follow-up

  2. Patient satisfaction

    Time frame: Pre-treatment and at final follow-up

  3. Side effects

    Time frame: At each follow-up visit (week 3, 6, 9, 12)

Sponsors and collaborators

Lead sponsor

Laserklinik Karlsruhe

Other

Collaborators

  • Laser and Skin Centre Potsdam, Potsdam, Germany

Registry information

Official study title

A Multicenter Study of Fractional Photothermolysis in the Treatment of Melasma

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Nov 23, 2010
Registry last updated
Nov 23, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.