Effect of facial muscle exercise using a Pao device on facial rejuvenation and lip side to side movement during smile

Not Applicable

Completed

Conditions: Diseases of the skin and subcutaneous tissue

Registration Number: KCT0002808

Lead Sponsor: Yonsei University

Brief Summary: Results The 50 women [age 40.0 ± 10.0 (range 30–63) years] completed the protocol and provided data for analysis. Quantitative measurements of FMT and CSA Table 2 shows the mean (standard deviation) of FMT pre- and post-FME. The CSA of the zygomaticus major muscle increased significantly on both sides (right: p < 0.001, left: p = 0.015) after, compared with before, FMEuP. The bilateral increase in the CSA of the digastric muscle was also significant (right: p = 0.003, left: p = 0.001). The FMT of the levator labii superioris increased significantly on the right side (from 0.126 to 0.136cm; p = 0.006) compared with before FME, but not on the left side (from 0.125 to 0.128cm; p = 0.230). The pre- versus post-FMEuP values for the FMT differed significantly on the left (from 0.212 to 0.228 cm; p = 0.019) but not on the right (from 0.227 to 0.235cm; p = 0.183) side of the orbicularis oris muscle. Quantitative measurements of facial surface distances, facial surface areas, and volumes Tables 3 and 4 show the mean (standard deviation) facial surface distance, surface area, and volume pre- and post-FME. The mid-facial surface distance in the mid transverse plane (midpoint between the contact between the columella and philtrum and the center of Cupid’s bow of the upper lip) was significantly lower on both sides (right: p = 0.005, left: p = 0.047), as were the mid-facial surface distance in the lower transverse plane (center of Cupid’s bow of the upper lip; right: p = 0.028, left: p = 0.019) and the jawline surface distance (right: p = 0.004, left: p = 0.003). However, the difference between the pre- and post-FMEuP measurements of the mid-facial surface distance in the upper transverse plane (contact spot between the columella and philtrum) was not significant, bilaterally. The surface areas of the lower quadrants based on the corner of the mouth were significantly lower on both sides (right: p = 0.005, left: p = 0.006), as were the volumes of the same lower quadrants (right: p = 0.001, left: p = 0.002). Wrinkle Severity Rating Scale As shown in Table 5, the mean (standard deviation) of the WSRS pre- and post-FME was 2.582 ± 0.629 and 2.370 ± 0.708, respectively. The decrease was significant (p = 0.025). Face visual scale: Wrinkle and jawline sagging Table 5 also shows the mean (standard deviation) FVS values (wrinkle and jawline sagging) as self-reported by the study participants pre- and post-FME (3.855 ± 1.715 and 5.130 ± 1.493 for wrinkles and 4.000 ± 2.082 and 5.407 ± 1.666 for jawline sagging, respectively). The differences in both were significant (both p < 0.001).

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Female

Target Recruitment: 50

Inclusion Criteria

Fifty women who met our inclusion and exclusion criteria were recruited in Korea from those who filled out a questionnaire and answered positively concerning nasolabial folds or skin sagging around the mouth or jawline.

Exclusion Criteria

The exclusion criteria were (1) history of dermatological interventions on or around the mouth or jaw, such as laser treatment, chemical peels, injection of botulinum toxin, and dermal fillers, during the past 3 years; (2) history of plastic surgery on or around the mouth or jaw during the past 3 years; (3) history of cosmetic enhancement through facial muscle exercise; (4) history of smoking; and (5) dimpled face. All participants signed an informed consent form regarding the potential risks and benefits of facial muscle exercise using Pao.

Study & Design

Study Type: Interventional Study

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Quantitative measurements of facial muscle thickness;Quantitative measurements of facial muscle cross sectional area;Quantitative measurements of facial surface distances;Quantitative measurements of facial surface areas;Quantitative measurements of facial volumes

Secondary Outcome Measures