Fractional CO2 Laser-assisted Delivery of Hyaluronic Acid, Ascorbic Acid and Sodium DNA For Enhancing Facial Skin Quality in Individuals Over the Age of 30 (FCLADHAAASDFSQ)

Evaluate the effectiveness of topical hyaluronic acid, ascorbic acid, and sodium DNA following ablative fractional laser treatment in objectively reversing facial skin alterations induced by photoaging.

Study Overview

Detailed Description

The study involves the application of ascorbic acid, hyaluronic acid, and sodium DNA in preparation for their use following the administration of a fractional CO2 laser treatment. Participants will attend a total of four sessions. During the initial session, participants will complete and sign a consent form, baseline photographs will be captured for documentation purposes, and an initial assessment will be conducted using the SASSQ. At the second session, the fractional CO2 laser will be applied, followed by the application of the topical medication to the facial area. During the third and fourth sessions, scheduled one week and four weeks post-treatment, respectively, the facial dermal effects will be objectively evaluated using the SASSQ scale, and any adverse effects will be assessed and documented through photographs.

To facilitate the analysis and comparison of variables, an analysis of variance will be conducted utilizing the ANOVA test for repeated measures. The IBM SPSS Statistics software, version 29.0, will be employed for this purpose. A p-value of less than 0.05 will be regarded as statistically significant.

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Daniel B Mejia Llanes MD, Medical Doctor
  • Phone Number: +503 6420 5801
  • Email: db.mejia@outlook.com

Study Locations

    • Mexico City
      • Mexico City, Mexico City, Mexico, 06800
        • Recruiting
        • Instituto de Oftalmologia F.A.P. Conde de Valenciana, I.A.P.
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Male and female subjects, over 30 years of age, with moderate skin changes associated with elasticity, wrinkles, roughness, pigmentation, erythema, and pore size; with at least 12 points on the SASSQ scale. Fitzpatrick skin type I-III. Participants who agree to take part in the protocol

Exclusion Criteria:

  • Fitzpatrick skin type IV-VI. Local infections or inflammatory disorders.. Neoplasms suspected of being malignant. Allergy to hyaluronic acid, ascorbic acid, and sodium DNA. Hypersensitivity to fractional CO2 laser. Pregnancy or breastfeeding. Local or systemic adverse reaction

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Application of ascorbic acid, hyaluronic acid, and sodium DNA in preparation for their use following
Participants will attend a total of four sessions. During the initial session, participants will complete and sign a consent form, baseline photographs will be captured for documentation purposes, and an initial assessment will be conducted using the SASSQ. At the second session, the fractional CO2 laser will be applied, followed by the application of the topical medication to the facial area. During the third and fourth sessions, scheduled one week and four weeks post-treatment, respectively, the facial dermal effects will be objectively evaluated using the SASSQ scale, and any adverse effects will be assessed and documented through photographs.
The study involves the application of ascorbic acid, hyaluronic acid, and sodium DNA in preparation for their use following the administration of a fractional CO2 laser treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Skin quality
Time Frame: From enrollment to the end of treatment at 4 weeks
Quantitative enhancement that can be assessed using a validated scale (SASSQ)
From enrollment to the end of treatment at 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 7, 2025

Primary Completion (Estimated)

February 28, 2026

Study Completion (Estimated)

April 30, 2026

Study Registration Dates

First Submitted

January 21, 2026

First Submitted That Met QC Criteria

January 21, 2026

First Posted (Actual)

January 29, 2026

Study Record Updates

Last Update Posted (Actual)

January 29, 2026

Last Update Submitted That Met QC Criteria

January 21, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Time Frame

Abril 2026 - December 2026

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Photo-aged Skin

Clinical Trials on topical hyaluronic acid, ascorbic acid, and sodium DNA following ablative fractional laser treatment

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