Status:

COMPLETED

Fractional Photothermolysis for Treating Melasma

Lead Sponsor:

Laserklinik Karlsruhe

Collaborating Sponsors:

Laser and Skin Centre Potsdam, Potsdam, Germany

Conditions:

Melasma

Eligibility:

All Genders

Phase:

NA

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...

Eligibility Criteria

Inclusion

  • 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

  • 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).

Key Trial Info

Start Date :

March 1 2008

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

December 1 2009

Estimated Enrollment :

51 Patients enrolled

Trial Details

Trial ID

NCT01245881

Start Date

March 1 2008

End Date

December 1 2009

Last Update

November 23 2010

Active Locations (1)

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Laserklinik Karlsruhe

Karlsruhe, Germany, 76133