Fractional Photothermolysis for Treating Melasma

NCT01245881 | Completed

• 1 other identifier: LK-13-2010
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

controlled trial; fractional photothermolysis; laser surgery; melasma; pigment disorder

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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)

Study Arms (2)

Treatment group

EXPERIMENTAL

Broad-spectrum UV block plus non-ablative 1,550-nm fractional treatment

Device: Non-ablative fractional photothermolysis laser

Control group

ACTIVE COMPARATOR

Other: broad-spectrum sunblock (SPF 50+)

Interventions

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.

Treatment group

broad-spectrum sunblock (SPF 50+) OTHER

Control group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults (female/male) with clinical evidence of melasma;
• Fitzpatrick skin phototype I-III;
• Ability and willingness to comply with the requirements of the protocol.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Laserklinik Karlsruhe: lead
• Laser and Skin Centre Potsdam, Potsdam, Germany: collaborator

Study Sites (1)

Laserklinik Karlsruhe

Karlsruhe, 76133, Germany

Location

MeSH Terms

Conditions

Melanosis; Pigmentation Disorders

Condition Hierarchy (Ancestors)

Hyperpigmentation; Skin Diseases; Skin and Connective Tissue Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 19, 2010
• First Posted: November 23, 2010
• Study Start: March 1, 2008
• Primary Completion: September 1, 2009
• Study Completion: December 1, 2009
• Last Updated: November 23, 2010

Record last verified: 2010-11

Locations

DE (1)