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

NCT07372001 | Completed Phase 4 DMC

• 1 other identifier: CEI-2024/04/02
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Skin Aging

Keywords

Exosomes.; Skin; Skin Aging; Rejuvenation

Outcome Measures

Primary Outcomes (2)

• Facial dermal changes

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

  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.

  From enrollment to the end of treatment at 8 weeks

Study Arms (1)

Topical lyophilized exosomes application

OTHER

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.

Biological: Topical lyophilized exosomes application

Interventions

Topical lyophilized exosomes application BIOLOGICAL

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

Also known as: Exosomes

Topical lyophilized exosomes application

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Instituto de Oftalmología Fundación Conde de Valenciana: lead

Study Sites (1)

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

Mexico City, Mexico City, 08800, Mexico

Location

Related Publications (15)

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Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: January 20, 2026
• First Posted: January 28, 2026
• Study Start: July 1, 2024
• Primary Completion: December 1, 2024
• Study Completion: March 1, 2025
• Last Updated: January 28, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: March 2026 - June 2026

Locations

ME (1)