TRIA FRX - STUDY 1

A two-center safety and efficacy clinical study using Tria FRX’s laser system 1.

An investigational 1440 nm non-ablative fractional diode laser [Tria FRX] was developed for consumer use in the treatment of facial fine lines and wrinkles, dyschromia, and tactile skin roughness. This study was designed to demonstrate safety and efficacy of the home-use laser device.

Claims based on this study.

1

89%

of users see improved skin texture / smoother skin.

2

82%

see visible improvement in pigmentation / dark spots.

3

78%

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 both sides 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)

75.9%

71.4%

77.8%
Fine lines and wrinkles (other areas)

72.4%

75.0%

77.8%
Brown areas/spots

65.5%

75.0%

81.5%
Skin texture

75.9%

78.6%

88.9%

Blind expert panel and investigator results.

(12 weeks 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

0.6* ± 0.6

0.8* ± 0.6

0.8* ± 0.7
Dyschromia

0.4* ± 0.7

0.7* ± 0.6

1.0* ± 0.5
Tactile roughness

2.4* ± 1.3

2.6* ± 1.5

2.8* ± 0.8

Principal investigator's conclusion.

"The study demonstrated that the home-use 1440 nm non-ablative fractional laser resulted in statistically significant and clinically meaningful improvement in periorbital wrinkles, dyschromia, and tactile roughness. Treatment was extremely well tolerated and had minimal risk to participants. In summary, this technology is a non-invasive option for consumers interested in treating photodamaged skin at home."

- Dr. James J. Leyden