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

Instituto de Oftalmología Fundación Conde de Valenciana

Status and phase: Completed; Phase 4

Conditions: Skin Aging

Treatments: Biological: Topical lyophilized exosomes application

Study type: Interventional

Funder types: Other

Identifiers

NCT07372001

CEI-2024/04/02

Details and patient eligibility

About

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

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Topical lyophilized exosomes application

Other group

Description:

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.

Treatment:

Biological: Topical lyophilized exosomes application