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

JRCT ID: jRCTs032230006

Registered date:04/04/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Atopic Dermatitis
• Date of first enrollment: 04/04/2023
• Target sample size: 20
• Study type: Interventional
• Intervention(s): Use the facial machine on one side of the face, 3 days a week, once a day for 8 weeks.

Outcome(s)

• Primary Outcome: 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

Secondary Outcome

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

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: < 60age old
• Gender: Both

Include criteria

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

Exclude criteria

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

Related Information

• Primary Sponsor: Yoshizaki Ayumi