Clinical Study Partner: Media Lab Science, Los Angeles
Authors: Therabody Scientists: Tim Roberts, MSc; Kyle Silvey, PhD; Michelle Darian, MS, MPH, RD, LDN 

Abstract

Background: LED light therapy has become increasingly popular for consumers seeking science-backed solutions for their skincare. LED light therapy masks have appeared on the market as a convenient, hands-free way to treat the face. The TheraFace Mask by Therabody has 648 LEDs, more than is found in many similar products, allowing the optimal light dose to be delivered to the full face in a short, convenient treatment time. The TheraFace Mask also incorporates vibration therapy to treat both the eye area and the scalp. With any novel technology, it is critical to quantify the efficacy and ensure the device’s safety. Therefore, the study aimed to investigate the impact of this revolutionary device on its ability to improve clinical facial health outcomes following a 12-week protocol.   

Methods: This 12-week clinical study measured the efficacy of the TheraFace Mask device in 31 male and female subjects aged 39-64 and spanning multiple skin types and ethnicities. Study subjects were instructed to use the product starter guide and complete one preset 9-minute LED light therapy treatment per day, Monday through Saturday, and a 15-minute vibration therapy-only treatment on Sunday. Baseline and endpoint assessments were completed at weeks 0, 8, and 12 using Digital imaging, Visia®-CR imaging, Expert Grading, and subjective perception through questionnaires. 

Results: At both the 8 and 12-week timepoints, TheraFace Mask was clinically shown to improve the following: dark spots and age spots, full-face line lines, full-face wrinkles, overall healthy skin appearance, radiance, and luminosity, skin tone evenness, skin texture and smoothness, facial contour, and firmness. 

Conclusion: TheraFace Mask was clinically effective in improving multiple skin and facial health and wellness measures. Consumers can use findings from the study to optimize how they integrate the TheraFace Mask into their beauty and skincare device routines.

Study Background

The beauty industry has experienced significant growth in recent years and is expected to continue expanding. As the industry grows, there is an increased focus on creating safe and effective products. Regulators require beauty device makers to demonstrate the efficacy of their products through rigorous testing. Consumers are also seeking out clinically validated products they can trust. To meet these demands, companies conduct extensive clinical trials overseen by medical experts to evaluate product safety, efficacy, and reliability before bringing items to market. These third-party clinical studies help ensure companies can substantiate claims and give consumers confidence in new beauty technologies. [1]

LED light therapy has gained interest recently across social media, and companies have jumped at the chance to develop products for this science-backed trend. As the FDA tightly regulates these devices, many companies seek to replicate the specifications of other products already being sold for an easier path to market. To drive innovation in optimizing the dose of light received evenly across the skin in the shortest but safest treatment time and to integrate new technologies to enhance both the treatment and the experience, Theraboody created the TheraFace Mask. As a core equity of the Therabody Beauty business, third-party clinical testing was conducted to seek validation of TheraFace Mask’s science and technology. 

Beauty devices on the market contain technology that can provide therapeutic benefits. These technologies can leverage modalities such as LED light therapy, vibration, and more, yet few technologies combine modalities to maximize benefit. Current beauty device modalities are scientifically backed to improve both objective and subjective measures of beauty and skin health as described in the methods below. For example, LED light therapy and vibration therapy have proven benefits in isolation. 

LED Light Therapy

LED (light emitting diode) therapy is a skincare treatment for several conditions using varying wavelengths of light, including red, blue, and infrared, to stimulate the skin and tissue beneath. While LED light therapy gained popularity in dermatology and aesthetician offices, it has started to gain its presence as an at-home treatment. [2] 

LED light therapy is widely researched for its science-backed benefits on facial and skin health using varying wavelengths of light. Light’s wavelength determines its color, with lower wavelengths presenting as blue and longer wavelengths presenting as red. Some wavelengths, like infrared light, aren’t visible to the naked eye. [3] 

Different wavelengths can have therapeutic effects on the body. Longer wavelengths of light in the red spectrum can penetrate deeply into skin tissue and can improve fine lines. Shorter wavelengths act and benefit the skin on its surface. Infrared light, with the longest wavelengths, can reach even deeper below the skin into tissues to benefit muscle and bone. Therapeutic light treatments use different parts of the light spectrum, with varying depths of tissue penetration, to promote various beneficial health effects. [4] 

Vibration Therapy

Vibration therapy creates a massage that helps relieve tension on treatment areas, for example, around the temples, brow, and scalp. This therapy also helps boost circulation around the eye area, which can result in a refreshed appearance. Vibration therapy can increase local blood flow and tissue oxygenation. It increases circulation, which helps to stimulate blood flow and deliver oxygen and nutrients to the treatment area. This treatment modality also aids in collagen production. Collagen declines with age, contributing to wrinkles and skin sagging. The creation of new collagen can help to combat these features of aging skin. [5] 

Study Hypothesis

Following a 12-week protocol, TheraFace Mask will effectively improve measures of facial skin health, including the appearance and depth of full-face fine lines and wrinkles around those around the eyes, firmness, radiance, and overall skin appearance.

Study Methods

Study Participants 

The study included male and female subjects between 39 and 64 years old, with a mean age of 54. The participants presented with multiple skin types: Fitzpatrick Skin Types I-IV, Hispanic, African American, Caucasian, and Asian skin types were represented. A total of 36 participants were enrolled in the study, and 31 completed the study. Study participants self-reported perceptions of uneven skin tone (pigment), lack of elasticity, lines and wrinkles, and dull complexion at baseline. 

Research Design

A 12-week monadic clinical study on the efficacy of the Theraface Mask device was conducted. Clinical assessments were performed on study participants at three time periods: baseline, 8 weeks, and 12 weeks. The 36 study subjects who met the inclusion and non-inclusion criteria were instructed to follow the weekly protocol outlined in the product starter guide for the 12-week study period. They were assessed and supervised throughout the study by clinic technicians to monitor for any possible adverse events. 

Study Protocol

The study protocol included using TheraFace Mask’s 9-minute preset treatment daily, Monday through Saturday, 6 days per week for the 12-week study duration. This 9-minute preset treatment cycles through 3-minute treatments of red, red+infrared, and blue LED light therapy in combination with vibration therapy. Study participants used the 15-minute vibration therapy-only preset on Sundays and did not use LED light therapy.

Data Collection

Data was collected from participants via four data collection modalities: expert grading, digital imaging, Visia®-CR imaging, and a self-assessment of subjective perception through questionnaires. All data was collected at three time points: baseline, 8 weeks, and 12 weeks.

Digital imaging and expert grading were used to quantify and assess facial features like fine lines, deep wrinkles, firmness, elasticity, skin tone, overall appearance, and more. Visia®-CR imaging is a quantitative skin complexion analysis and visual assessment of facial features like facial contour, spots, and pores. [6] A self-assessment was administered to measure subjective perception of notable visual changes throughout the study protocol. There were 20 questions included in the questionnaire, including self-perceived skin appearance, changes in fine lines and wrinkles, skin elasticity, skin tone, and more.  

Data Analysis 

The data was analyzed using descriptive statistics and a student t-test to compare baseline measurements to those at 8 and 12-week follow-up.

Ethics

This study was conducted in compliance with the Declaration of Helsinki principles, the applicable regulatory requirements, and according to the Good Clinical Practices (Document of the Americas and ICH E6: Good Clinical Practices).

Study Findings + Discussion

This clinical trial found that the TheraFace Mask device and associated protocol clinically improved multiple measures of skin and facial health. The TheraFaceMask device demonstrated its ability to improve the appearance and depth of fine lines and wrinkles, skin extensibility, skin firmness, facial contour, lifting and the appearance of sagging skin, visual and tactile smooth skin texture, and skin radiance and luminosity. 

Improves Appearance of Fine Lines and Wrinkles

Fine Lines

Full-face fine lines were assessed via expert clinical grading. Full-face fine lines significantly improved at both 8 and 12 weeks (p<0.001). Full-face fine lines improved by an average of 17.7% after 12 weeks, with 93.5% of participants showing clinical improvement after 12 weeks. Study participants also reported perceptual improvements in full-face and eye area fine lines, with 80% reporting notable improvements after 8 weeks and 83.9% at 12 weeks.

Wrinkles

Full-face wrinkles were assessed via expert clinical grading. Full-face wrinkles significantly improved at both 8 (p=0.025) and 12 (p<0.001) weeks. Full-face wrinkles improved by an average of 10.8% after 12 weeks, with 71% of participants showing clinical improvement after 12 weeks. Study participants also reported perceptual improvements in the appearance and depth of full-face and eye area wrinkles, with 66.7% reporting notable improvements after 8 weeks and 77.4% at 12 weeks. 

Facial fine lines and wrinkles also significantly improved as assessed by VISIA image analysis after both 8 and 12 weeks (p<0.001), indicating a significant reduction in fine lines and wrinkles.

Improves Firmness, Facial Contour, and Sagging Skin

Skin Firmness

The clinical study found significant improvements in skin firmness through multiple measures of skin health. When firmness was assessed via expert clinical grading, improvements were significant at both 8 (p=0.003) and 12 (p<0.001) weeks. Firmness improved by an average of 6.9% in the total population after 12 weeks, with 54.8% of participants showing clinical improvement after 12 weeks. Study participants also reported perceptual improvements in firmness, with 70% reporting notable improvements after 8 weeks and 83.9% at 12 weeks. 

Facial Contour

Facial contour was assessed via VISIA imaging analysis. Results were significant at both 8 and 12 weeks (p<0.001). A significant reduction of the Polygon Area parameter was observed after 8 and 12 weeks, indicating an improvement of the face contour (V-shape). After 12 weeks, there was a mean improvement of 7.2%, with 70.4% of participants experiencing improvement. 

Sagging Skin

Sagging skin was assessed via expert clinical grading. Changes in sagging skin were not significant at 8 weeks (p=0.163) but significantly improved at 12 weeks (p=0.003). The mean improvement at the group level was 2.4% after 12 weeks, with 22.6% of participants showing clinical improvement after 12 weeks. Study participants also reported perceptual improvements in sagging skin, with 60% reporting notable improvements after 8 weeks and 74.2% at 12 weeks. 

Improves Appearance of Skin Tone Evenness With Visible Dark Spot Lightening

Skin Tone Evenness

Skin tone evenness was assessed via expert clinical grading. Skin tone evenness significantly improved at both 8 and 12 weeks (p<0.001). The average improvement in skin tone evenness was 10.9% after 12 weeks, with 54.8% of participants showing clinical improvement after 12 weeks. Skin tone evenness also improved as assessed by VISIA imaging analysis. Results were not significant at 8 weeks but were significant at 12 weeks (p<0.001), indicating spot lightening and improvement of skin tone evenness. Study participants also reported perceptual improvements in skin tone, with 86.7% reporting notable improvements after 8 weeks and 87.1% at 12 weeks. 

Dark Spot and Age Spot Lightening 

Based on expert clinical grading, dark and age spots significantly improved at both 8 and 12 weeks (p<0.001). The mean improvement in dark and age spots between baseline and 12 weeks was 14.5%, with 77.4% of participants showing clinical improvement after 12 weeks. Study participants also reported perceptual improvements in dark spots and age spots, with 63.3% reporting notable improvements after 8 weeks and 77.4% at 12 weeks.

Improves Skin Radiance and Luminosity, and the Overall Appearance of Healthy Skin

Skin Radiance and Luminosity

Skin radiance and luminosity were assessed via expert clinical grading. Radiance and luminosity significantly improved at both 8 and 12 weeks (p<0.001). These measures improved by an average of 8.7% after 12 weeks, with 51.6% of participants showing clinical improvement after 12 weeks. Study participants also reported perceptual improvements in skin rejuvenation, luminosity, and glow, with 93.3% reporting notable improvements after 8 weeks and 90.3% at 12 weeks. 

Overall Appearance of Healthy Skin

The overall skin appearance of healthy skin significantly improved via expert clinical grading at both 8 and 12 weeks (p<0.001). The average improvement was 12.7% after 12 weeks, with 83.9% of participants showing clinical improvement after 12 weeks. Study participants also reported perceptual improvements in overall skin appearance, with 93.3% reporting notable improvements after 8 weeks and 93.5% at 12 weeks. 

Improves Skin Texture and Smoothness

Skin texture and smoothness significantly improved at both 8 and 12 weeks (p<0.001) as assessed by expert clinical grading. These measures improved by an average of 11.5% after 12 weeks, with 64.5% of participants showing clinical improvement after 12 weeks. Skin texture also significantly improved through VISIA image analysis after 12 weeks (p<0.001), indicating a reduction in fine lines and wrinkles as a measure of improvement in skin texture. Study participants also reported perceptual improvements in smoothing of the skin, with 96.7% reporting notable improvements after 8 weeks and 93.5% at 12 weeks. 

Conclusion

This study showed that a LED light therapy device that uses 648 LEDs to optimize the science-backed safe and effective dose of light was clinically validated to improve skin health in 12 weeks. Notable clinical improvements from objective measures include: 

References