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Fractional Photothermolysis for Treating Melasma

Primary Purpose

Melasma

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Non-ablative fractional photothermolysis laser
broad-spectrum sunblock (SPF 50+)
Sponsored by
Laserklinik Karlsruhe
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Melasma focused on measuring controlled trial, fractional photothermolysis, laser surgery, melasma, pigment disorder

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Laserklinik Karlsruhe

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Treatment group

Control group

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Subjective assessment of treatment outcome (by patients)
Patient satisfaction
Side effects

Full Information

First Posted
November 19, 2010
Last Updated
November 22, 2010
Sponsor
Laserklinik Karlsruhe
Collaborators
Laser and Skin Centre Potsdam, Potsdam, Germany
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1. Study Identification

Unique Protocol Identification Number
NCT01245881
Brief Title
Fractional Photothermolysis for Treating Melasma
Official Title
A Multicenter Study of Fractional Photothermolysis in the Treatment of Melasma
Study Type
Interventional

2. Study Status

Record Verification Date
November 2010
Overall Recruitment Status
Completed
Study Start Date
March 2008 (undefined)
Primary Completion Date
September 2009 (Actual)
Study Completion Date
December 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Laserklinik Karlsruhe
Collaborators
Laser and Skin Centre Potsdam, Potsdam, Germany

4. Oversight

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Melasma
Keywords
controlled trial, fractional photothermolysis, laser surgery, melasma, pigment disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
51 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment group
Arm Type
Experimental
Arm Description
Broad-spectrum UV block plus non-ablative 1,550-nm fractional treatment
Arm Title
Control group
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
Non-ablative fractional photothermolysis laser
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
broad-spectrum sunblock (SPF 50+)
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
Subjective assessment of treatment outcome (by patients)
Time Frame
Pre-treatment and at final follow-up
Title
Patient satisfaction
Time Frame
Pre-treatment and at final follow-up
Title
Side effects
Time Frame
At each follow-up visit (week 3, 6, 9, 12)

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Facility Information:
Facility Name
Laserklinik Karlsruhe
City
Karlsruhe
ZIP/Postal Code
76133
Country
Germany

12. IPD Sharing Statement

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Fractional Photothermolysis for Treating Melasma

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