On the use of a pilot sample for sample size determination.
R H Browne
https://pubmed.ncbi.nlm.nih.gov/8532986Actively Recruiting
Phase 4
Age: 30Years +
All Genders
ID07376148
Fractional CO2 Laser-assisted Delivery of Hyaluronic Acid, Ascorbic Acid and Sodium DNA for Improving Facial Skin Quality in Adults Over 30
Led by Instituto de Oftalmología Fundación Conde de Valenciana · Updated on 2026-01-29
30
Participants Needed
1
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the use of topical hyaluronic acid, ascorbic acid, and sodium DNA applied after ablative fractional CO2 laser treatment to improve facial skin quality in people over 30 years old. The study aims to objectively measure how these treatments may reverse facial skin changes caused by photoaging, such as wrinkles, pigmentation, and loss of elasticity. This is a phase 4 interventional trial sponsored by Instituto de Oftalmología Fundación Conde de Valenciana. Participants will attend four sessions. The first session includes signing consent, baseline photos, and an initial skin assessment using the SASSQ scale. In the second session, the fractional CO2 laser treatment is applied followed immediately by the topical application of the study medications to the face. The third and fourth sessions happen one week and four weeks after treatment, respectively, where skin effects and any side effects are evaluated using SASSQ and documented with photographs. During the study, researchers will monitor changes in skin quality from enrollment through four weeks after treatment. Assessments include objective skin evaluations, photographs, and adverse event tracking. Statistical analysis will be performed using ANOVA tests for repeated measures to compare results over time. Participants will be closely observed throughout the study to measure the effects of the laser and topical treatments on photo-aged skin.
CONDITIONS
Brief Title
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
Who Can Participate
Age: 30Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Male and female subjects over 30 years old
- Moderate skin changes including elasticity loss, wrinkles, roughness, pigmentation, erythema, and pore size
- Score of at least 12 points on the SASSQ scale
- Fitzpatrick skin types I to III
- Agree to participate in the study protocol
You will not qualify if you...
- Fitzpatrick skin types IV to VI
- Local infections or inflammatory skin disorders
- Suspicion of malignant neoplasms
- Allergy to hyaluronic acid, ascorbic acid, or sodium DNA
- Hypersensitivity to fractional CO2 laser treatment
- Pregnancy or breastfeeding
- Local or systemic adverse reactions
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 4 weeks
Participants receive a fractional CO2 laser treatment followed by the application of topical hyaluronic acid, ascorbic acid, and sodium DNA. This stage includes the initial treatment session and follow-up assessments of facial skin quality and any adverse effects.
4 sessions: initial consent and assessment, treatment application, and follow-ups at 1 week and 4 weeks post-treatment
Trial Site Locations
Total: 1 location
1
Instituto de Oftalmología F.A.P. Conde de Valenciana, I.A.P.
Mexico City, Mexico City, Mexico, 06800
Actively Recruiting
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Research Team
D
Daniel B Mejia Llanes MD, Medical Doctor
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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