Skin Aging, Skin Quality
Conditions
Keywords
Skin Aging, Skin Quality, Exosomes, PDRN, Microneedling
Brief summary
This exploratory clinical study evaluated changes in facial skin quality following a series of mechanical microneedling treatments combined with topical AnteAGE Exosomes and PEARL Multiplier and a standardized AnteAGE homecare regimen. Participants underwent three microneedling treatments at approximately 4-week intervals. Outcomes included instrumental skin measurements, standardized facial imaging, investigator assessments, participant-reported outcomes, and assessment of treatment tolerability.
Detailed description
This was an open-label, single-arm exploratory clinical study evaluating changes in facial skin quality following mechanical microneedling combined with topical AnteAGE Exosomes and PEARL Multiplier. Participants underwent three mechanical microneedling treatments approximately 4 weeks apart. Study products were applied during and/or immediately following treatment, and participants followed a standardized homecare regimen during the study. Assessments included standardized facial imaging, instrumental measurements of skin properties, investigator assessments, participant-reported outcomes, and safety and tolerability assessments. Participants were followed through approximately 12 weeks.
Interventions
OTHERAnteAGE Exosomes and PEARL Multiplier
Topical AnteAGE Exosomes and PEARL Multiplier were applied during and/or immediately following mechanical microneedling according to the study protocol.
Participants used AnteAGE MD Serum, Accelerator and Cleanser daily, AnteAGE Face Mask weekly, and SPF 30+ daily during the study.
PROCEDUREMechanical microneedling
Mechanical facial microneedling was performed using the Candela Exceed device on three occasions approximately 4 weeks apart.
Sponsors
Cellese Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
35 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Male or female participants aged 35-65 years * Fitzpatrick Skin Types I-VI * In good general health and able to comply with study procedures * Willing to abstain from non-study topical treatments and cosmetic procedures during the study * Able to provide written informed consent
Exclusion criteria
* Active skin infection or inflammatory skin condition * Systemic retinoid use within 6 months * Corticosteroid or immunomodulator use within 4 weeks * History of keloid formation or hypertrophic scarring * Facial cosmetic procedures within 3 months * Pregnant or breastfeeding * Uncontrolled medical condition or bleeding disorder * Known allergy to any study-product ingredient * Use of photosensitizing medication
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in Skin Elasticity | Baseline, Week 4, Week 8, and Week 12 | Skin elasticity was assessed instrumentally as average skin retraction time. Change from baseline in skin retraction time was evaluated over the 12-week study period, with decreased retraction time indicating faster skin recovery and improved elasticity. |
| Change From Baseline in Coarse Facial Wrinkle Total Area | Baseline, Week 4, Week 8, and Week 12 | Facial wrinkles were assessed using standardized VISIA facial imaging. Coarse wrinkle total area was quantified at each assessment, and change from baseline was evaluated over the 12-week study period. Decreased coarse wrinkle total area indicates improvement in facial wrinkle appearance. |
| Change From Baseline in Transepidermal Water Loss (TEWL) | Baseline, Week 4, Week 8, and Week 12 | Skin barrier function was assessed by measurement of transepidermal water loss (TEWL), expressed in g/m²/h. Change from baseline in TEWL was evaluated over the 12-week study period, with lower TEWL indicating reduced transepidermal water loss and improved skin barrier function. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Facial Red Features | Baseline, Week 4, Week 8, and Week 12 | Facial erythema-associated red features were quantified using standardized VISIA facial imaging and Red/Brown/X (RBX) analysis. Change from baseline in red feature count was evaluated over the study period, with lower counts indicating fewer erythema-associated facial features. |
| Participant-Reported Improvement in Skin Quality | Week 12 | Participants assessed perceived changes in skin hydration, radiance, texture, fine lines and wrinkles, elasticity, hyperpigmentation/dark spots, and overall skin appearance using the study-specific participant questionnaire. |
| Incidence of Treatment-Emergent Adverse Events | From first treatment through Week 12 | Number of participants experiencing treatment-emergent adverse events during the study. Adverse events were assessed for severity and relationship to the study treatment. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORRob Knight, PhD
Cellese Inc.
Outcome results
None listed