The Study Design
BY DAN FRIEDMANN, MD
This third-party clinical trial was a single-center (one location), prospective (patients were followed over time), open-label (patients and provider were aware of treatment), split-axillary (one underarm was tested) with a contralateral control (the opposite was a control) before-after study design.
Each subject performed at-home self-administered treatment to a single axillary area twice weekly for 12 weeks. The study included up to 6 visits at the clinic: initial screening, 48 hour baseline grading, 3 follow-up visits in 1-month intervals, and 1 Follow-up visit at 1 month following the end of at-home treatment.
OUTLINE OF THE CLINICAL TRIAL
SAMPLE SIZE
40 People
AGES
18-45
TIMEFRAME
4 Months
97% Patients Were Satisfied
The subject’s overall satisfaction with treatment outcome was recorded during in-clinic follow ups after 4, 8, 12 and 16 weeks of treatment. At the end of the trial 8 subjects reported “moderate satisfaction”, 16 subjects reported “good satisfaction”, and 7 subjects reported “very good satisfaction”.
PATIENT SATISFACTION
PATIENT SATISFACTION
CATILIN B. | AGE: 42
“I noticed a big improvement in hair loss and large improvement in texture. After treatment the very little hair that I had left was much finer & thinner.”
92% Saw Hair Reduction
Efficacy of treatment was measured during in-clinic follow ups after 4, 8, 12 and 16 weeks of treatment. At the end of the trial, 19 subjects rated improvement as “improved”, 11 subjects rated improvement as “much improved”, and 3 subjects rated improvement as “very much improved”.
HAIR REDUCTION
HAIR REDUCTION
Susan K. | AGE: 34
“I like the convenience of in-home treatments. I don’t typically share beauty tips with my friends but I will recommend this device to my friends.”
Discomfort
The average discomfort experience was measured halfway through the 12-week treatment period with the device set to Level 7. Subjects rated their pain by marking a validated 10-cm horizontal line visual analogue scale (from 0 ‘no pain’ to 10 ‘intolerable pain’). The average discomfort during the trial was < 1.
Before and Afters
SELECTED BEFORE & AFTERS FROM CLINICAL TRIAL
REBECCA K. | AGE: 24
KELLY J. | AGE: 32
MEGAN F. | AGE: 28