Fractional Photothermolysis for Treating Melasma

Melasma Clinical Trial

Official title:

A Multicenter Study of Fractional Photothermolysis in the Treatment of Melasma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01245881
• Other study ID #: LK-13-2010
• Status: Completed
• Phase: N/A
• First received: November 19, 2010
• Last updated: November 22, 2010
• Start date: March 2008
• Est. completion date: December 2009

Study information

• Verified date: November 2010
• Source: Laserklinik Karlsruhe
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: December 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 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

Intervention

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+)

Locations

Country	Name	City	State
Germany	Laserklinik Karlsruhe	Karlsruhe

Sponsors (2)

Lead Sponsor	Collaborator
Laserklinik Karlsruhe	Laser and Skin Centre Potsdam, Potsdam, Germany

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Secondary	Subjective assessment of treatment outcome (by patients)		Pre-treatment and at final follow-up	No
Secondary	Patient satisfaction		Pre-treatment and at final follow-up	No
Secondary	Side effects		At each follow-up visit (week 3, 6, 9, 12)	Yes