TRIA 4X - STUDY 3

Short term simulated consumer use of Tria 4X’s laser system 2.

In this clinical study, the safety, efficacy, and usability of the Spectra Hair Removal Laser [Tria 4X] and its labelling were evaluated in simulated consumer use to support an FDA 510(k) submission for over-the-counter clearance.

Claims based on this study.

1

75%

See up to 75% hair reduction following just 2 treatments.

2

Visible results

See visible results in just 2 treatments.

3

60%

See up to 60% hair reduction following just 1 treatment.

BEFORE & AFTER

Hair removal results from real Tria 4X users.

Full study breakdown.

52 participants self administered laser treatments with Tria 4X’s laser system. All participants were adults with naturally brown or black hair and skin types I-IV on Fitzpatrick Scale.
University of Arizona Health Sciences Center, Tucson, AZ.
The principal investigator of this study was Dr Ronald G. Wheeland, a well respected dermatologist and laser surgeon. He was the Professor & Chief of Dermatology at multiple universities, including University of Arizona (at the time of this study), as well as the former President of the American Academy of Dermatology, President of the American Society for Dermatologic Surgery, and President of the American Society for Laser Medicine and Surgery, and an inductee into the Dermatology Hall of Fame.
Participants received 3 treatments. Results were measured by a clinician who performed hair counts in the treated areas 3 weeks post-treatment.
Read this study in its entirety here.

Clinician hair count results.

(Each count was conducted 3 weeks post-treatment, except for the final count which was done 4 weeks post-treatment*)

Mean hair count reduction (%)
1 Treatment (3 weeks post-treatment)

60.4%
2 Treatments (3 weeks post-treatment)

74.7%
3 Treatments (4 weeks post-treatment)

62.3%*

*Note: the additional week will have affected results vs. a 3 week wait period, therefore this result is not mentioned in wider marketing due to the lack of consistency.

Principal investigator's conclusion.

"The efficacy, safety, and usability results, combined with a Class 1 laser classification, demonstrate that the Tria 4X’s laser system has a benefit-to-risk ratio appropriate for over-the-counter use."

- Dr. Ronald G. Wheeland