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

Phase 4CompletedNCT07372001

Instituto de Oftalmología Fundación Conde de Valenciana30 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Skin Aging

Interventions

Topical lyophilized exosomes applicationBIOLOGICAL

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

Eligibility

Sex: ALLMin age: 50 Years

Medical Language ↔ Plain English

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.

Locations (1)

Instituto de Oftalmología F.A.P. Conde de Valenciana, I.A.P.

Mexico City, Mexico City, Mexico

Outcomes

Primary Outcomes

Facial dermal changes

Six skin characteristics were evaluated using SASSQ visual scale: elasticity, wrinkles, roughness, pigmentation, erythema, and pore size

Time frame: From enrollment to the end of treatment at 8 weeks

Subjective evaluation of facial dermal changes

The 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.

Time frame: From enrollment to the end of treatment at 8 weeks

Data from ClinicalTrials.gov

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