Fractional Photothermolysis for Treating Melasma

A Multicenter Study of Fractional Photothermolysis in the Treatment of 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).

Study Overview

• Status: Completed
• Conditions: Melasma
• Intervention / Treatment: Device: Non-ablative fractional photothermolysis laser; Other: broad-spectrum sunblock (SPF 50+)

• Study Type: Interventional
• Enrollment (Actual): 51
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Karlsruhe, Germany, 76133
    • Laserklinik Karlsruhe

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control group	Other: broad-spectrum sunblock (SPF 50+)
Experimental: Treatment group; Broad-spectrum UV block plus non-ablative 1,550-nm fractional treatment	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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)

Collaborators and Investigators

• Sponsor: Laserklinik Karlsruhe
• Collaborators: Laser and Skin Centre Potsdam, Potsdam, Germany

Study record dates

Study Major Dates

• Study Start: March 1, 2008
• Primary Completion (Actual): September 1, 2009
• Study Completion (Actual): December 1, 2009

Study Registration Dates

• First Submitted: November 19, 2010
• First Submitted That Met QC Criteria: November 22, 2010
• First Posted (Estimate): November 23, 2010

Study Record Updates

• Last Update Posted (Estimate): November 23, 2010
• Last Update Submitted That Met QC Criteria: November 22, 2010
• Last Verified: November 1, 2010

More Information

Terms related to this study

• Keywords: melasma; controlled trial; laser surgery; fractional photothermolysis; pigment disorder
• Additional Relevant MeSH Terms: Skin Diseases; Hyperpigmentation; Pigmentation Disorders; Melanosis; Physiological Effects of Drugs; Protective Agents; Dermatologic Agents; Radiation-Protective Agents; Sunscreening Agents
• Other Study ID Numbers: LK-13-2010