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Fractional Photothermolysis for Treating Melasma

This study has been completed.
Sponsor:
Collaborator:
Laser and Skin Centre Potsdam, Potsdam, Germany
Information provided by:
Laserklinik Karlsruhe
ClinicalTrials.gov Identifier:
NCT01245881
First received: November 19, 2010
Last updated: November 22, 2010
Last verified: November 2010
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Subjective assessment of treatment outcome (by patients) [ Time Frame: Pre-treatment and at final follow-up ] [ Designated as safety issue: No ]
  • Patient satisfaction [ Time Frame: Pre-treatment and at final follow-up ] [ Designated as safety issue: No ]
  • Side effects [ Time Frame: At each follow-up visit (week 3, 6, 9, 12) ] [ Designated as safety issue: Yes ]

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

Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01245881

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

No publications provided

Responsible Party: Christian Raulin, MD, Laserklinik Karlsruhe, Karlsruhe, Germany
ClinicalTrials.gov Identifier: NCT01245881     History of Changes
Other Study ID Numbers: LK-13-2010
Study First Received: November 19, 2010
Last Updated: November 22, 2010
Health Authority: Germany: Ethics Commission

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

Additional relevant MeSH terms:
Melanosis
Hyperpigmentation
Pigmentation Disorders
Skin Diseases

ClinicalTrials.gov processed this record on May 23, 2013