Health TrialsbyHealthPanel

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

ConditionsSkin AppearanceSkin TextureSkin SaggingWrinkles
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age30-65
SponsorAPR Co., Ltd.

About this trial

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 criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Multi-functional Home-use Beauty Device

    Device

    A home-use facial beauty device intended for cosmetic skin improvement.

  • Topical Skincare Serum

    Other intervention

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

  • Skincare Mask

    Other intervention

    Topical facial serum sheet mask applied to the skin.

Treatment groups

50 Participants
are divided into 8 treatment groups

8

Treatment groups

See each treatment group below.

Group A: Group 1: Device Mode A + Skincare ProductExperimental treatment 2 interventions
Group B: Group 2: Device Mode B + Skincare ProductExperimental treatment 2 interventions
Group C: Group 3: Device Mode C + Skincare ProductExperimental treatment 2 interventions
Group D: Group 4: Device Mode D + Skincare ProductExperimental treatment 2 interventions
Group E: Group 5: Device Mode E + Skincare ProductExperimental treatment 2 interventions
Group F: Group 6: Skincare Product ControlActive comparator 1 intervention
Group G: Group 7: Device Mode F + Skincare MaskExperimental treatment 2 interventions
Group H: Group 8: Skincare Mask ControlActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Week 2 and Week 4

Secondary outcomes

1

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.

Time frame
Week 2 and Week 4
2

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.

Time frame
Week 2 and Week 4
3

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.

Time frame
Week 2 and Week 4
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.

Time frame
Through Week 4

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

APR Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov
Apply now