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Effects on Facial Skin Aging After Topical Application of Exosomes With a Microneedling Device

Effects on Facial Skin Aging After Topical Application of Exosomes With a Microneedling Device

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07372001
Acronym
EFSATAEMD
Enrollment
30
Registered
2026-01-28
Start date
2024-07-01
Completion date
2025-03-01
Last updated
2026-01-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Skin Aging

Keywords

Exosomes., Skin, Skin Aging, Rejuvenation

Brief summary

In this study, we evaluated the extent of reversal of facial dermal aging signs using topical lyophilized exosomes with a microneedling device

Detailed description

This clinical, experimental, prospective, and comparative investigation was conducted in a before-and-after format. The exosomes were applied to the facial area by dripping onto the skin and using a microneedling device to enhance dermal penetration. Three sessions, each four weeks apart, were performed for each subject. During each session, documentation was performed using photographs and the SAASQ and FaceQ visual scales for objective and subjective evaluations, respectively. ANOVA test for repeated measures was used for the statistical analysis. SPSS version 31.0 was used for the analysis. All measured variables, both objective and subjective, were favorable for the use of exosomes as a treatment for early signs of aging. This pilot study provides preliminary results showing an excellent cosmetic response to exosome treatment using microneedling, with good user satisfaction and tolerable and harmless adverse effects.

Interventions

BIOLOGICALTopical lyophilized exosomes application

The exosomes were applied to the facial area by dripping onto the skin and using a microneedling device to enhance dermal penetration. Three sessions, each four weeks apart, were performed for each subject

Sponsors

Instituto de Oftalmología Fundación Conde de Valenciana
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

This was a clinical, experimental, prospective, and comparative investigation conducted in a before-and-after format

Eligibility

Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Men and women over the age of 50 with facial rhytides and a minimum score of 12 on the SASSQ scale

Exclusion criteria

* pregnancy or breastfeeding, active acne or rosacea, local infections, lesions suspicious for malignancy, and allergy to exosomes. The elimination criteria involved loss of follow-up of the research subject and the occurrence of an allergic reaction or intolerable adverse effects.

Design outcomes

Primary

MeasureTime frameDescription
Facial dermal changesFrom enrollment to the end of treatment at 8 weeksSix skin characteristics were evaluated using SASSQ visual scale: elasticity, wrinkles, roughness, pigmentation, erythema, and pore size
Subjective evaluation of facial dermal changesFrom enrollment to the end of treatment at 8 weeksThe FACE-Q Aesthetics questionnaire was utilized, comprising 37 independent functional scales and six checklists that measure patient-relevant outcomes from their perspective. In this study, the following scales from this questionnaire were used: expectations (before), satisfaction with skin (before and after), psychosocial distress related to appearance (before and after), assessment of facial lines: general impression (before and after), and satisfaction with the decision (after). Additionally, an adverse effects scale was used.

Countries

Mexico

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026