Skin AppearanceNCT07871708
Clinical Evaluation of a Multi-functional Beauty Device on Cosmetic Skin Outcomes
A study testing Multi-functional Home-use Beauty Device, Topical Skincare Serum and Skincare Mask in people with Skin Appearance and Skin Texture, run by APR Co., Ltd. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Skin Appearance, Skin Texture, Skin Sagging
- What is being tested?
- Multi-functional Home-use Beauty Device, Topical Skincare Serum and Skincare Mask
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Sep 2026to 28 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female adults aged 30 to 65 years, inclusive.
- Fitzpatrick skin type I through V.
- In generally good health, as determined by medical history and investigator judgment.
- 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.
- 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.
- Able to understand the study requirements and willing to provide written informed consent.
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- Able to use a smartphone daily to download and use a device-related application.
- 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.
- Able to understand the nature of the study and any potential hazards associated with participating in it.
- Willing and able to attend all scheduled study visits.
- Participant of childbearing potential is willing to use an acceptable method of contraception throughout the duration of the trial.
Who cannot join
- 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]).
- History of facial nerve disorder, including but not limited to Bell's palsy or trigeminal neuralgia.
- History of seizure disorder or epilepsy.
- Presence of implanted medical devices such as pacemakers or implantable defibrillators.
- Presence of plastic or silicone implants in or near the treatment area.
- 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).
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- Current use of isotretinoin or use within 6 months prior to screening.
- 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).
- 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).
- Pregnant, breastfeeding, or planning to become pregnant during the study period.
- History of poor wound healing, keloid formation, or hypertrophic scarring.
- Current participation in another investigational study or use of an investigational device or product within 30 days prior to screening.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Johns Hopkins University School of Medicine
Baltimore, Maryland, 21205
About this study
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.
- Conditions
- Skin Appearance, Skin Texture, Skin Sagging, Wrinkles
- Being tested
- Multi-functional Home-use Beauty Device, Topical Skincare Serum, Skincare Mask
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multi-functional Home-use Beauty DeviceDevice
A home-use facial beauty device intended for cosmetic skin improvement.
Topical Skincare SerumOther
Topical facial skincare serum applied as part of the skin care regimen.
Skincare MaskOther
Topical facial serum sheet mask applied to the skin.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Device Mode A + Skincare Product | Experimental | Use of device mode A combined with a topical skincare serum. Receives: Device: Multi-functional Home-use Beauty Device; Other: Topical Skincare Serum |
| Group 2: Device Mode B + Skincare Product | Experimental | Use of device mode B combined with a topical skincare serum. Receives: Device: Multi-functional Home-use Beauty Device; Other: Topical Skincare Serum |
| Group 3: Device Mode C + Skincare Product | Experimental | Use of device mode C combined with a topical skincare serum. Receives: Device: Multi-functional Home-use Beauty Device; Other: Topical Skincare Serum |
| Group 4: Device Mode D + Skincare Product | Experimental | Use of device mode D combined with a topical skincare serum. Receives: Device: Multi-functional Home-use Beauty Device; Other: Topical Skincare Serum |
| Group 5: Device Mode E + Skincare Product | Experimental | Use of combined device modes with a topical skincare serum, supported by a device application. Receives: Device: Multi-functional Home-use Beauty Device; Other: Topical Skincare Serum |
| Group 6: Skincare Product Control | Active comparator | Application of the topical skincare serum alone, without device usage. Receives: Other: Topical Skincare Serum |
| Group 7: Device Mode F + Skincare Mask | Experimental | Use of device mode F applied over a specialized skincare mask. Receives: Device: Multi-functional Home-use Beauty Device; Other: Skincare Mask |
| Group 8: Skincare Mask Control | Active comparator | Application of the specialized skincare mask alone, without device usage. Receives: Other: Skincare Mask |
What is being measured
The primary outcome is the main question the study is designed to answer.
Global Aesthetic Improvement Scale (GAIS) Score as Assessed by Clinician
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.
Measured: Week 2 and Week 4
Secondary outcomes (4)
Change from Baseline in Skin Texture Score
Assessed by the clinician on a 5-point ordinal scale (0 = None/Very smooth, 1 = Mild, 2 = Moderate, 3 = Severe, 4 = Very Severe/Extremely rough). Lower scores indicate smoother skin texture.
Measured: Week 2 and Week 4
Change from Baseline in Clinician Wrinkle Assessment Scale (CWAS) Score
Assessed by the clinician across facial areas on a 5-point ordinal scale (0 = None, 1 = Mild, 2 = Moderate, 3 = Severe, 4 = Very Severe). Lower scores indicate less wrinkle severity.
Measured: Week 2 and Week 4
Change from Baseline in Global Pore Appearance Scale (GPAS) Score
Assessed by the clinician on a 7-point ordinal scale (0 = Not visible to 6 = Extremely prominent). Lower scores indicate less visible pores.
Measured: Week 2 and Week 4
Incidence and Severity of Local Skin Reactions (LSR) and Treatment-Emergent Adverse Events (TEAE)
Monitored through clinical evaluation of local skin reactions (erythema, edema, skin irritation/dermatitis, bruising graded on a 0-3 scale) and incidence of adverse events graded per CTCAE v5.0 throughout the study period.
Measured: Through Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2026
- Study start9 Sep 2026
- Primary completion31 Dec 2026 (estimated)
- Study completion28 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin AppearanceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- APR Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Farah Succaria, Assistant professor, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07871708
- Sponsor's protocol ID
- APR-X2-001
- Status last verified
- Sep 2026
- First submitted
- 8 Oct 2026
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of a Multi-functional Beauty Device on Cosmetic Skin Outcomes
- ClinicalTrials.gov ID
- NCT07871708
- Acronym / sponsor ID
- APR-X2-001
- Conditions
- Skin Appearance, Skin Texture, Skin Sagging, Wrinkles
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- APR Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 9 Sep 2026 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 28 Feb 2027 (estimated)
- First posted
- 13 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Group 1: Device Mode A + Skincare Product | Experimental | Device: Multi-functional Home-use Beauty Device, Other: Topical Skincare SerumUse of device mode A combined with a topical skincare serum. |
| Group 2: Device Mode B + Skincare Product | Experimental | Device: Multi-functional Home-use Beauty Device, Other: Topical Skincare SerumUse of device mode B combined with a topical skincare serum. |
| Group 3: Device Mode C + Skincare Product | Experimental | Device: Multi-functional Home-use Beauty Device, Other: Topical Skincare SerumUse of device mode C combined with a topical skincare serum. |
| Group 4: Device Mode D + Skincare Product | Experimental | Device: Multi-functional Home-use Beauty Device, Other: Topical Skincare SerumUse of device mode D combined with a topical skincare serum. |
| Group 5: Device Mode E + Skincare Product | Experimental | Device: Multi-functional Home-use Beauty Device, Other: Topical Skincare SerumUse of combined device modes with a topical skincare serum, supported by a device application. |
| Group 6: Skincare Product Control | Active comparator | Other: Topical Skincare SerumApplication of the topical skincare serum alone, without device usage. |
| Group 7: Device Mode F + Skincare Mask | Experimental | Device: Multi-functional Home-use Beauty Device, Other: Skincare MaskUse of device mode F applied over a specialized skincare mask. |
| Group 8: Skincare Mask Control | Active comparator | Other: Skincare MaskApplication of the specialized skincare mask alone, without device usage. |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Male or female adults aged 30 to 65 years, inclusive.
- Fitzpatrick skin type I through V.
- In generally good health, as determined by medical history and investigator judgment.
- 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.
- 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.
Key exclusion criteria (12 listed)
- 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]).
- History of facial nerve disorder, including but not limited to Bell's palsy or trigeminal neuralgia.
- History of seizure disorder or epilepsy.
- Presence of implanted medical devices such as pacemakers or implantable defibrillators.
- Presence of plastic or silicone implants in or near the treatment area.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multi-functional Home-use Beauty DeviceA home-use facial beauty device intended for cosmetic skin improvement. | Device | Group 1: Device Mode A + Skincare Product, Group 2: Device Mode B + Skincare Product, Group 3: Device Mode C + Skincare Product, Group 4: Device Mode D + Skincare Product, Group 5: Device Mode E + Skincare Product, Group 7: Device Mode F + Skincare Mask |
| Topical Skincare SerumTopical facial skincare serum applied as part of the skin care regimen. | Other | Group 1: Device Mode A + Skincare Product, Group 2: Device Mode B + Skincare Product, Group 3: Device Mode C + Skincare Product, Group 4: Device Mode D + Skincare Product, Group 5: Device Mode E + Skincare Product, Group 6: Skincare Product Control |
| Skincare MaskTopical facial serum sheet mask applied to the skin. | Other | Group 7: Device Mode F + Skincare Mask, Group 8: Skincare Mask Control |
Primary outcome
Global Aesthetic Improvement Scale (GAIS) Score as Assessed by Clinician
Time frame: 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.
4 secondary outcomes
Change from Baseline in Skin Texture Score
Time frame: Week 2 and Week 4
Change from Baseline in Clinician Wrinkle Assessment Scale (CWAS) Score
Time frame: Week 2 and Week 4
Change from Baseline in Global Pore Appearance Scale (GPAS) Score
Time frame: Week 2 and Week 4
Incidence and Severity of Local Skin Reactions (LSR) and Treatment-Emergent Adverse Events (TEAE)
Time frame: Through Week 4
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Farah Succaria, Assistant professor principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multi-functional Home-use Beauty Device, Topical Skincare Serum and Skincare Mask in people with Skin Appearance and Skin Texture, run by APR Co., Ltd. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gwangjun Park (+82-10-9159-7604, kjhsb@apr-in.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Global Aesthetic Improvement Scale (GAIS) Score as Assessed by Clinician (time frame: Week 2 and Week 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.