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)

Instituto de Oftalmología Fundación Conde de Valenciana

Status and phase: Enrolling; Phase 4

Conditions: Photo-aged Skin; Drug Delivery Systems; Skin Quality Improvement

Treatments: Drug: topical hyaluronic acid, ascorbic acid, and sodium DNA following ablative fractional laser treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT07376148

CEI-2025/05/04

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 30+ years old

Volunteers: No Healthy Volunteers

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

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

Application of ascorbic acid, hyaluronic acid, and sodium DNA in preparation for their use following

Experimental group

Description:

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.

Treatment:

Drug: topical hyaluronic acid, ascorbic acid, and sodium DNA following ablative fractional laser treatment