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: While many skincare products and devices are on the market, TheraFace PRO was the first beauty-tech device to combine eight treatment modalities into a single device. With any novel technology, it is critical to quantify the efficacy and ensure the safety of the device. Therefore, the study aimed to investigate the impact of this revolutionary device on its ability to improve clinical skincare outcomes following a 12-week protocol.   

Methods: This 12-week clinical study measured the efficacy of the TheraFace PRO device in 35 male and female subjects aged 25-61 and spanning multiple skin types. Study subjects were instructed to use the product starter guide, which includes set protocols for all eight treatment modalities: red, blue, and red+infrared LED light therapy, percussive therapy, heat and cold therapy, cleansing, and microcurrent. Endpoints were assessed at 6 and 12 weeks using Expert Grading, Digital imaging, Visia®-CR imaging, Cutometer® instrumentation, and subjective perception through questionnaires. 

Results: After 12 weeks, TheraFace PRO was clinically shown to improve the following: skin elasticity, skin extensibility, firmness, and facial contour; the appearance and depth of fine lines and wrinkles on the face and around the eyes; skin tone evenness; overall healthy skin appearance; lift the neck and jowl lines; facial contour; visual and tactile smooth skin texture; skin radiance, luminosity, and glow; and skin lifting and the appearance of sagging skin. 

Conclusion: TheraFace PRO was clinically effective in improving multiple skin and facial health and wellness measures. Findings from the study can be used to optimize future TheraFace PRO skincare protocols for best-in-class facial health solutions. 

Study Background

The beauty industry has grown considerably over the last several years, and consumer reports project its continued growth. [1] With the industry’s growth comes the attention to developing safe and effective products. Regulatory agencies require beauty device manufacturers to adopt procedures that lead them to quantify the efficacy of their products, and consumers are increasingly searching for clinically validated products. To this end, third-party research teams conduct clinical tests on product safety and efficacy, coordinated by expert physicians, before bringing a product to market. In doing so, companies can evaluate products’ safety, effectiveness, and reliability to bring consumers technology they can trust. [2]

Beauty devices on the market typically utilize a single technology to deliver therapeutic treatments. It is common for consumers to own several different beauty devices of varying technologies to complete their skincare routines. While these technologies deliver proven benefits to the skin, using different technologies for different treatments can often be time-consuming, inefficient, and complicated to get correct. However, to date, no devices containing eight science-backed technologies in a single device have been clinically validated to make having a comprehensive skincare routine at home simple and effective. 

Current beauty device modalities are scientifically backed to improve measures of beauty and skin health. For example, LED light therapy, percussive therapy, heat and cold therapy, and microcurrent have proven benefits in isolation. 

LED Light Therapy

LED light therapy often includes red, blue, and infrared light therapy. Each of these three colors represents a different wavelength of light. Light penetrates through the skin to produce beneficial effects — with different wavelengths of light penetrating the skin at varying depths. Different wavelengths of light can have therapeutic effects on the skin and body.

Longer wavelengths, around 620 to 750 nanometers, known as red light, can penetrate deep into skin tissue to provide benefits like skin rejuvenation. [3] Blue light therapy utilizes shorter wavelengths, around 415 nanometers, that act on the skin’s surface. Research indicates blue light can have healing effects on superficial skin areas. [4] Infrared light, with the longest wavelengths around 830 nanometers, can reach even deeper below the skin into tissues like muscle and bone. Studies suggest that the advantages of infrared therapy include enhanced skin rejuvenation and improved muscle recovery. [5] Overall, therapeutic light treatments harness different parts of the light spectrum, with varying depths of tissue penetration, to achieve a range of beneficial health effects.

Percussive Therapy

Percussive therapy is the rapid and repetitive application of pressure perpendicular to the body. This percussive stimulus causes the treatment area to experience both pressure and vibration simultaneously. The physiological and neurological responses to the pressure and vibration produce therapeutic effects that may benefit the treatment area depending on the timing, duration, and application area. [6] 

Microcurrent Therapy

Microcurrent therapy is a gentle skin treatment that uses small electrical currents to stimulate the facial muscles. The low-level voltage applied during microcurrent facials helps tone and firm the skin by causing subtle muscle contractions. This stimulation is a “workout for the face" that can temporarily tighten, tone, and contour the treatment area. Microcurrent therapy can lead to the appearance of reduced wrinkles and is particularly effective for forehead wrinkles. This modality is often found as an option in spas and clinics and has more recently become popular for at-home use in the past decade. [7] 

Heat Therapy

Heat therapy, also known as thermotherapy, is a process where the body is exposed to high temperatures for therapeutic purposes. A rise in skin temperature leads to the widening of blood vessels (vasodilation), resulting in increased blood flow to the treatment area. Blood flow and increased circulation can improve measures of facial health like fine lines. [8] 

Cold Therapy

Cold therapy, or cryotherapy, exposes the body to low temperatures for therapeutic purposes, resulting in the reduction of blood flow to the treatment area. Limiting blood flow to a treatment area can decrease inflammation levels. [9] 

Study Purpose

The study aimed to investigate the impact of an eight-in-one beauty-tech solution, the TheraFace PRO device. Using a protocol that includes LED light therapy, percussive therapy, microcurrent therapy, cleansing, and heat cold therapy, the TheraFace PRO device was studied for its ability to improve self-perceived and clinically measured facial health outcomes. 

Study Hypothesis

Following a 12-week TheraFace PRO protocol will effectively improve skin elasticity, the appearance and depth of fine lines and wrinkles around the eyes, radiance, and overall skin appearance.

Study Methods

Study Participants 

The study included male and female subjects between 25 and 61 years old, with a mean age of 43. 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 40 participants were enrolled in the study, and 35 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 PRO device was conducted. Clinical assessments were performed on study participants at three time periods: baseline, 6 weeks, and 12 weeks. The 35 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 red, blue, and red+infrared light therapy in combination with percussive therapy treatments three times per week for 6 minutes on Monday, Wednesday, and Friday. Participants used the microcurrent and cleanse attachments twice weekly for 6 minutes on Tuesday and Thursday. Once per week, participants used the comprehensive PRO treatment of light, percussive therapy, microcurrent therapy, cleansing, heat, and cold therapy for 45 minutes on Sunday. 

Data Collection

Data was collected from participants via five data collection modalities: digital imaging, Visia®-CR imaging, Cutometer® MPA 580 instrumental device, and subjective perception through questionnaires. All data was collected at three time points: baseline, 6 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. [10] The Cutometer® MPA 580 instrumental device was used to measure skin elasticity and skin extensibility at baseline. [11] 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 6 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 PRO device and associated protocol clinically improved multiple measures of skin and facial health. The TheraFace PRO device demonstrated its ability to improve skin elasticity, 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 Skin Elasticity

The elasticity of the epidermis (the top layer of skin) was assessed using the Cutometer device viscoelastic measurements. Skin elasticity significantly improved at week 6 (29.4% mean improvement, with 87% of participants showing improvement, p<0.001) and at week 12 (13% mean improvement, with 83% of participants showing improvement, p<0.001). Based on expert clinical grading, skin elasticity did not significantly improve at week 6 but did significantly improve after 12 weeks (p<0.001). Skin elasticity improved by an average of 9.2%, with 57.1% of participants showing clinical improvements. 

Improves Appearance of Full-Face Fine Lines and Fine Lines Around the Eyes

Expert clinical grading showed that the appearance of full-face fine lines and fine lines around the eyes significantly improved at both 6 and 12 weeks (p<0.001). Full-face fine lines improved by an average of 33.8%, with 77.1% of participants showing improvement after 12 weeks. Fine lines around the eyes also improved. Participants experienced an average improvement of 44.5%, with 91.4% of participants showing improvements in fine lines around the eyes. Study participants also reported perceptual improvements in fine lines, with 68.6% reporting notable improvements after 6 weeks and 71.4% at 12 weeks. 

Improves Appearance and Depth of Full-Face Wrinkles and Wrinkles Around the Eyes

Through expert clinical grading, the appearance and depth of full-face wrinkles and wrinkles around the eyes significantly improved at both 6 and 12 weeks (p<0.001). Full-face wrinkles improved by an average of 30.3%, with 77.1% of participants showing improvement after 12 weeks. Wrinkles around the eyes also improved. Participants experienced an average improvement of 45.3%, with 97.1% of participants showing improvements in wrinkles around the eyes. Study participants also reported perceptual improvements in wrinkles, with 62.9% reporting notable improvements after 6 weeks and 68.6% at 12 weeks. 

Improves Skin Extensibility

Extensibility is a multidimensional measure of softness that measures the skin’s ability to be stretched and bounce back to its original shape. Improvements in extensibility were not significant at 6 weeks (p=0.094) but did significantly improve at 12 weeks (13.6% mean improvement, with 71.4% of participants showing improvement, p=0.008). 

Improves Firmness

Through expert clinical grading, the visual firmness of skin significantly improved at both 6 and 12 weeks (p<0.001). The appearance of skin firmness improved by an average of 24.7%, with 97.1% of participants showing improvement after 12 weeks. Participants also self-reported improvements in visual firmness of the skin, with 97.1% reporting notable improvements after 6 weeks and 80% at 12 weeks. 

Improves Facial Contour 

Facial contour significantly improved at both 6 and 12 weeks (p<0.001). Facial contour improved by an average of 16.5%, with 85.7% of participants improving after 12 weeks. Participants also self-reported improvements in facial contour, with 71.4% reporting notable improvements after 6 weeks and 88.6% at 12 weeks. Using VISIA quantitative skin complexion analysis and visual assessment, measures of facial contour significantly improved after 12 weeks. The assessment found that 80% of participants had a reduced polygon area, leading to a more V-shape, a measure of facial contour. A reduction in the polygon area indicates a lifting effect of the jowls, with improvements also noted after 6 weeks. 

Improves Lifting and Sagging in the Mid-Face, Neck, or Jowls

Through expert clinical grading, the visual lifting of participants’ skin significantly improved at both 6 and 12 weeks (p<0.001). Skin lifting improved by an average of 20.5%, with 97.1% of participants improving after 12 weeks. Participants also self-reported improvements in lifting their skin, with 57.1% reporting notable improvements after 6 weeks and 77.1% at 12 weeks. 

Visually Smooths Skin Texture

Skin texture appeared clinically visually smoother at both 6 and 12 weeks (p<0.001). Skin texture smoothing improved by an average of 17.1%, with 94.3% of participants improving after 12 weeks.

Tactilely Smooths Skin Texture

Through expert clinical grading, skin texture was tactilely smoother at both 6 and 12 weeks (p<0.001). Skin texture smoothing improved by an average of 28.7%, with 94.3% of participants improving after 12 weeks. Participants also self-reported improvements in tactile skin smoothing, with 68.6% reporting notable improvements after 6 weeks and 77.1% at 12 weeks. 

Improves Skin Radiance, Luminosity, and Glow

Expert clinical grading found that skin appeared more radiant, luminous, and glowing at both 6 and 12 weeks (p<0.001). Skin visually improved in radiance and luminosity by an average of 18.4%, with 82.9% of participants improving after 12 weeks. Participants also self-reported improvements in radiance and luminosity, with 91.4% reporting notable improvements after 6 weeks and 88.6% at 12 weeks. 

Conclusion

This study showed that a device containing eight science-backed technologies in a single technology was clinically validated to improve skin health in 12 weeks. Notable improvements include: 

References