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Fractional Photothermolysis for Treating Melasma

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01245881
First Posted: November 23, 2010
Last Update Posted: November 23, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Laser and Skin Centre Potsdam, Potsdam, Germany
Information provided by:
Laserklinik Karlsruhe
  Purpose
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).

Condition Intervention
Melasma Device: Non-ablative fractional photothermolysis laser Other: broad-spectrum sunblock (SPF 50+)

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multicenter Study of Fractional Photothermolysis in the Treatment of Melasma

Further study details as provided by Laserklinik Karlsruhe:

Primary Outcome Measures:
  • 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 Measures:
  • Subjective assessment of treatment outcome (by patients) [ Time Frame: Pre-treatment and at final follow-up ]
  • Patient satisfaction [ Time Frame: Pre-treatment and at final follow-up ]
  • Side effects [ Time Frame: At each follow-up visit (week 3, 6, 9, 12) ]

Enrollment: 51
Study Start Date: March 2008
Study Completion Date: December 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Active Comparator: Control group Other: broad-spectrum sunblock (SPF 50+)

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01245881


Locations
Germany
Laserklinik Karlsruhe
Karlsruhe, Germany, 76133
Sponsors and Collaborators
Laserklinik Karlsruhe
Laser and Skin Centre Potsdam, Potsdam, Germany
  More Information

Responsible Party: Christian Raulin, MD, Laserklinik Karlsruhe, Karlsruhe, Germany
ClinicalTrials.gov Identifier: NCT01245881     History of Changes
Other Study ID Numbers: LK-13-2010
First Submitted: November 19, 2010
First Posted: November 23, 2010
Last Update Posted: November 23, 2010
Last Verified: November 2010

Keywords provided by Laserklinik Karlsruhe:
controlled trial
fractional photothermolysis
laser surgery
melasma
pigment disorder

Additional relevant MeSH terms:
Melanosis
Hyperpigmentation
Pigmentation Disorders
Skin Diseases