Combined 755nm Alexandrite Laser With Bipolar RF for Hair Reduction (NCT02465788) | Clinical Trial Compass
UnknownNot Applicable
Combined 755nm Alexandrite Laser With Bipolar RF for Hair Reduction
United States29 participantsStarted 2014-05
Plain-language summary
The objective of this post marketing study is to further explore a variety of treatment parameters in order to optimize the optical (laser) and electrical (RF) treatments over the various skin types, when using a combination 755 nm alexandrite laser together with a bipolar RF energy system, for the purpose of hair reduction.
Who can participate
Age range18 Years – 80 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Subject is not pregnant and does not plan to become pregnant during their 16 month study period
✓. Subject has a minimum terminal hair density of 15 black or brown hairs in all 3cm x 3cm hair count evaluation areas. To distinguish terminal hair from vellus hair: terminal hairs are thicker, longer, and darker compared to vellus hairs which are short, fine and lightly color
✓. Subject is willing to have 5cm x 5cm square patches of reduced hair on all treatment areas for some time during and after the study period, perhaps even permanently
✓. Subject is willing to participate in the study
✓. Subject is willing to avoid sun exposure and tanning of the treatment areas for a time spanning two weeks before the first treatment to two weeks after the last treatments
✓. Subject has the ability to adhere to post treatment care requirements.
✓. Subject can commit to follow-up schedule
✓. Subject is willing to have photographs taken of the treated area which will be used de-identified in evaluations and may be used de-identified in presentations and/or publications
Exclusion criteria
✕. Subject has only white, red, blond or grey hairs in the treatment areas
✕. Subject has injury, scarring or infection in the treatment areas
✕. Subject has a tattoo in the treatment areas
What they're measuring
1
Average percentage of hair reduction by hair counts at baseline compared to 3 months after last treatment
Timeframe: Baseline, 3 months after last treatment
✕. Subject is pregnant or is lactating or plans to become pregnant during their 16 month study period. Pregnancy will be assessed by question at screening
✕. Subject is not willing to have long term hair loss in the treated areas
✕. Subject is not willing to discontinue shaving treatment areas at least one week prior to treatment and follow-up visits
✕. Subject has an active electrical implant anywhere in the body, such as a pacemaker, an internal defibrillator, insulin pump, incontinence device, etc
✕. Subject is photosensitive due to having a condition such as porphyria, polymorphic light eruption, solar urticaria, lupus, etc