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A Half-Side Comparative Study on Efficacy and Safety of Facial Machine with radio wave and EMS function on Skin of Adult Patients with Atopic Dermatitis

A Comparative Study of the Efficacy and Safety of a Facial Machine on the Skin of Adult Patients with Atopic Dermatitis

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Inclusion Criteria Participants must meet all of the following criteria: Patients who are not using a beauty device at the time of consent acquisition. Asian patients with mild to moderate atopic dermatitis (EASI score of 0 to 21) aged 18 to under 60 years, regardless of gender. Patients who have not changed their atopic dermatitis treatment regimen within one month prior to consent acquisition and have no plans to change their treatment regimen during the study period (changes in dosage are not restricted). Patients who are not undergoing treatment for comorbidities that may affect atopic dermatitis. Patients who can independently follow the instructed usage method. Patients who can attend outpatient visits according to the study schedule. Patients who have received sufficient explanation about the study, fully understood its details, and provided written informed consent of their own free will. Exclusion Criteria Participants will be excluded if they meet any of the following criteria: Patients with a history of hypersensitivity or contact dermatitis to materials used in the beauty device. Patients with erosion or ulcers on the face. Patients with malignant tumors (excluding those who have been completely cured by surgery or other treatments). Patients with significantly different skin conditions or symptoms between both sides of the face (EASI score difference of 30 or more between the left and right sides). Patients using any of the following medical electrical devices: implanted medical electrical devices such as pacemakers, life-supporting medical electrical devices such as artificial heart-lung machines, or wearable medical electrical devices such as electrocardiographs. Patients with heart disease, cardiac disorders, or suspected cardiac conditions. Patients who are unable to express their intentions. Patients who cannot perceive temperature or sensory stimuli. Non-Asian patients. Patients deemed inappropriate for study participation by the principal investigator or sub-investigators.

No participants were enrolled as the study could not proceed due to device malfunction.

None (as there are no cases conducted)

None (as there are no cases conducted)

Due to device malfunction, the study could not be conducted, and no subjects were enrolled before its termination.

April. 02, 2025

No

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https://jrct.mhlw.go.jp/latest-detail/jRCTs032230006

Yoshizaki Ayumi

The University of Tokyo Hospital

7-3-1 Hongo, Bunkyo-ku, Tokyo

ayuyoshi@g.ecc.u-tokyo.ac.jp

Omatsu Jun

The University of Tokyo Hospital

7-3-1 Hongo, Bunkyo-ku, Tokyo

+81-3-3815-5411

jun.omatsu@gmail.com

Complete

April. 04, 2023

Interventional

randomized controlled trial

single blind

no treatment control/standard of care control

parallel assignment

treatment purpose

1. Patients who did not use a facial machine at the time of informed consent
2. Asian patients aged 18 to 60 with mild to moderate atopic dermatitis (EASI score 0 to 21) regardless of gender
3. Patients who have not changed the therapeutic drug for atopic dermatitis from 1 month before obtaining informed consent and do not plan to change the therapeutic drug during the study period (there is no limit on the change in the amount used)
4. Patients who have not been treated for comorbidities that affect atopic dermatitis
5. Patients who can practice the instructed usage on their own
6. Patients who can go to the outpatient clinic according to the study implementation schedule
7. Patients who have given written informed consent of their own free will after receiving sufficient explanation about participating in this study

1. Patients who have experienced hypersensitivity or contact dermatitis to materials used in facial machine
2. Patients with erosions and ulcers on the face
3. Patients with malignant tumors (however, this does not apply if the tumor has been cured by surgery or other means)
4. Patients with significantly different skin conditions/symptoms on both sides of the face (Patients with a difference of 30 or more in EASI score between the left and right faces)
5. Patients using any of the following medical electrical devices: pacemakers and other implantable medical electrical devices, artificial heart lungs and other life-supporting medical electrical devices, and electrocardiographs and other wearable medical electrical devices
6. Patients with heart disease, disorders, or suspected heart disease
7. Patients unable to express their own will
8. Patients unable to perceive sensations of temperature or stimulation
9. Non-Asian patient
10. Patients who are judged inappropriate for participation in this study by the principal investigator or co-investigator

Both

Atopic Dermatitis

Use the facial machine on one side of the face, 3 days a week, once a day for 8 weeks.

Atopic Dermatitis

D003876

The difference in the average rate of change in the EASI (Eczema Area and Severity Index) score on the face between the side using the facial device and the non-using side 8 weeks after the start of the study

1. EASI score on the face (except after 8 weeks)
2. IGA score on the face
3. Water content in the stratum corneum of the face, transepidermal water loss, skin surface pH, sebum content, skin elasticity, melanin/erythema content, skin texture evaluation, skin color, skin blood vessel evaluation
4. Image analysis of skin by facial imaging device (pores, wrinkles, melanin, redness, amount of porphyrin and skin age)
5. Width of nasolabial folds and wrinkles around eyes by face imaging device
6. Visual inspection evaluation score by Skin Aging Scale for Asians
7. Changes in the volume of the forehead, cheeks, corners of the mouth, and face line using a facial volume 3D imaging device
8. QOL survey (DLQI (Dermatology Life Quality Index), WHO QOL26) score, pruritus NRS (Numerical Rating Scale) score
9. Scores from skin condition questionnaire and product questionnaire

+81-3-5841-0818

Mar. 29, 2023

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