TRIA FRX - STUDY 2

A two-center safety and efficacy clinical study using Tria FRX’s laser system 2.

To evaluate safety, efficacy, and tolerability of an investigational 1440 nm non-ablative fractional at-home laser device [Tria FRX] for the treatment of dyschromia, periorbital wrinkles, and textural irregularities, such as tactile roughness, on the face.

Claims based on this study.

1

92%

of users see improved skin texture / smoother skin.

2

84%

see visible improvement in pigmentation / dark spots.

3

80%

see reduced / visible improvement in wrinkles.

BEFORE & AFTER

Result photographs of participants in this clinical study.

Full study breakdown.

90 adult participants aged 32-70, skin tones I to VI on Fitzpatrick Scale. All had periorbital wrinkles, dyschromia, and tactile skin roughness on at least one side of the face.
This was a multi-center study across the following locations: KGL, Inc. Skin Study Center, Broomall, PA, Baumann Cosmetic and Research Institution, Miami Beach, FL, and Nashville Center for Laser and Facial Surgery, Nashville, TN.
The principal investigator of this study was Dr. James J. Leyden, Professor Emeritus of Dermatology at the University of Pennsylvania, a former consultant to the Food and Drug Administration, the Federal Trade Commission, and to drug regulation agencies in England, Germany, and Austria. A former member of the American Academy of Dermatology Board of Directors and former chairman of the Board of the Dermatology Foundation, he is internationally recognized for his contributions to dermatology, particularly to the understanding of the pathophysiology, diagnosis, and treatment of acne and rosacea.
Participants treated 5x per week for 12 weeks (with randomly assigned treatment level of low, medium or high). Participants self-assessed four categories: fine lines & wrinkles (periorbital), fine lines & wrinkles (other areas), brown areas/spots, and skin texture. Alongside self-assessments, a blind expert panel and investigator assessed the following categories 12 weeks post final treatment using a 9 point scale: periorbital wrinkles, dyschromia, tactile roughness.
Read this study in its entirety here.

Participant self-assessment results.

(12 weeks post final treatment)

Improvement in 'Low Cohort' (% of users) Improvement in 'Medium Cohort' (% of users) Improvement in 'High Cohort' (% of users)
Fine lines and wrinkles (periorbital)

72.0%

80.0%

72.7%
Brown areas/spots

72.0%

84.0%

81.8%
Skin texture

80.0%

92.0%

90.9%

Blind expert panel and investigator results.

(Post final treatment using a 9 point scale)

Point increase in 'Low Cohort' from Base Point increase in 'Medium Cohort' from Base Point increase in 'High Cohort' from Base
Periorbital wrinkles (4 weeks post-treatment)

0.9 ± 0.7

0.9 ± 0.6

0.9 ± 0.6
Dyschromia (4 weeks post-treatment)

0.4 ± 0.7

0.7 ± 0.6

1.0 ± 0.7
Tactile roughness

2.3 ± 1.7

2.2 ± 1.7

2.5 ± 1.1

Principal investigator's conclusion.

"At home 1440 nm non-ablative fractional laser [Tria FRX] offers an effective treatment for dyschromia, periorbital wrinkles, and tactile roughness with minimal risk to consumer safety. Significant improvement was observed for all treatment settings. Treatments were well tolerated with only trace-mild side effects. The study demonstrated significant benefits of at-home, fractional non-ablative treatments with minimal downtime."

- Dr. James J. Leyden