Low radiant exposures delivered by high-frequency and/or long-pulsed diode laser energy output in hair reduction: an intrapatient comparative, randomized double-blind trial (D800RCS)

Study identification

• EU PAS number:
  EUPAS9050
• Study ID:
  18713
• Official title and acronym:
  Low radiant exposures delivered by high-frequency and/or long-pulsed diode laser energy output in hair reduction: an intrapatient comparative, randomized double-blind trial (D800RCS)
• DARWIN EU® study:
  No
• Study countries:
  Slovenia
• Study description:
  This is a randomized patient- and assessor-blinded study aimed at studying efficacy and safety of various output parameters of diode hair removal lasers. Until now a majority of hair reduction lasers (diode and alexandrite) has been using pulse widths of 3-30 ms though selective photothermolysis theory predicts that pulse durations closer to 100 ms should be safer and more effective. The study is thus aimed at comparing either medium radiant exposure (18-20 J/cm2) longer pulses (100 ms) or low radiant exposure (6 J/cm2) but high frequency (10 Hz) pulses with multiple passes (up to 10) to a standard diode laser approach (25-35 J/cm2, 12.5-30 ms, single pulsed) in hair reduction. Both safety and efficacy will be looked at up to one year after completion of six laser treatments in the paired axiallar and bikini areas.
• Study status:
  Planned

Research institutions and networks

Institutions

Parmova Dermatology Center

Study timelines

Date when funding contract was signed

Planned:23/03/2015

Actual:23/03/2015

Study start date

Planned:09/05/2015

Date of final study report

Planned:24/05/2017

Sources of funding

Other

More details on funding

Own funds

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable