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Recruiting Not applicable

Clinical Evaluation of a Multi-functional Beauty Device on Cosmetic Skin Outcomes

NCT07871708 · tracked via the Priya Life Science USA tracker
Sponsor
APR Co., Ltd
Phase
Not applicable
Started
2026-09-09
Last updated
2026-10-13

Condition(s) studied

Skin AppearanceSkin TextureSkin SaggingWrinkles

Investigational drug(s) / intervention(s)

Multi-functional Home-use Beauty DeviceTopical Skincare SerumSkincare Mask

Multi-functional Home-use Beauty Device: A home-use facial beauty device intended for cosmetic skin improvement.

Topical Skincare Serum: Topical facial skincare serum applied as part of the skin care regimen.

Skincare Mask: Topical facial serum sheet mask applied to the skin.

Study summary

This study is designed to evaluate changes in cosmetic skin appearance and safety following at-home use of a multi-functional beauty device over a 4-week treatment period among approximately 50 participants.

Eligibility

Sex
ALL
Min age
30 Years
Max age
65 Years
Healthy volunteers
Accepted
Inclusion Criteria: 1. Male or female adults aged 30 to 65 years, inclusive. 2. Fitzpatrick skin type I through V. 3. In generally good health, as determined by medical history and investigator judgment. 4. Presenting with at least one visible cosmetic concern consistent with the study objectives, including but not limited to: fine lines or wrinkles (forehead, nasolabial, glabellar, or periorbital), reduced skin elasticity or facial muscle toning, visible sagging, visible pores, or skin texture irregularities. 5. Willing to refrain from cosmetic procedures affecting the face and neck (e.g., laser treatments, chemical peels, microneedling, fillers, botulinum toxin injections) for the duration of the study. 6. Able to understand the study requirements and willing to provide written informed consent. 7. Able to use a smartphone daily to download and use a device-related application. 8. Able to communicate satisfactorily with the investigator and to participate in, and comply with, the requirements of the study, including completion of weekly diary entries. 9. Able to understand the nature of the study and any potential hazards associated with participating in it. 10. Willing and able to attend all scheduled study visits. 11. Participant of childbearing potential is willing to use an acceptable method of contraception throughout the duration of the trial. Exclusion Criteria: 1. Active dermatologic conditions in the treatment area (e.g., eczema, psoriasis, active dermatitis, rosacea, active infection, open wounds, severe acne, sunburn \[visible redness, stinging/itching, and/or peeling\]). 2. History of facial nerve disorder, including but not limited to Bell's palsy or trigeminal neuralgia. 3. History of seizure disorder or epilepsy. 4. Presence of implanted medical devices such as pacemakers or implantable defibrillators. 5. Presence of plastic or silicone implants in or near the treatment area. 6. Receipt of cosmetic procedures affecting the face or neck within 90 days prior to screening (e.g., laser treatments, fillers, botulinum toxin, microneedling, chemical peels, dermabrasion). 7. Current use of isotretinoin or use within 6 months prior to screening. 8. Use of systemic or topical medications that may interfere with skin evaluation, including but not limited to retinoids, corticosteroids, or immunosuppressants (as determined by the investigator). 9. Known hypersensitivity or allergy to device materials (stainless steel, silicone) or any component of the study cosmetic product(s), or unwilling to use non-vegan products (cosmetic product\[s\] used in this study are formulated with salmon DNA PDRN). 10. Pregnant, breastfeeding, or planning to become pregnant during the study period. 11. History of poor wound healing, keloid formation, or hypertrophic scarring. 12. Current participation in another investigational study or use of an investigational device or product within 30 days prior to screening.

Primary outcome measure(s)

  • Global Aesthetic Improvement Scale (GAIS) Score as Assessed by Clinician — Week 2 and Week 4
    Assessed by the clinician relative to baseline using the 5-point Global Aesthetic Improvement Scale (GAIS), where 1 = Worse, 2 = No Change, 3 = Improved, 4 = Much Improved, and 5 = Very Much Improved. Higher scores indicate greater cosmetic skin appearance improvement.

Trial sites (1)

FacilityCityRegionStatus
Johns Hopkins University School of Medicine Baltimore Maryland Recruiting

Other trials for the same condition

Ovolux Beauty From Within Trial#2 Enrolling by invitation
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07871708 on ClinicalTrials.gov ↗ ← All trials in the USA