Intradermal Delivery of Fractional CO2 Laser-assisted Hyaluronic Acid in Facial Skin Remodeling
Overview
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Measurement of the improvment of one of the skin remodeling parameters (cutaneous texture, firmness, fine lines, radiance) using a scale from 0 to 10
Overview
Brief Summary
The main endpoint will be to evaluate the efficacy of laser-assisted hyaluronic acid delivery by fractional CO2 laser in facial skin remodeling. The secondary endpoint will be to confirm the safety of this protocol compared to a standard treatment by fractional CO2 laser.
Detailed Description
Fractional CO2 lasers are already used in skin remodeling. They can also create vertical channels to enhance topical drug delivery deep into the dermis. Combining the efficacy of fractional CO2 laser to laser-assisted hyaluronic acid delivery has not yet being studied, the combination of these two techniques could improve facial skin remodeling.
The main endpoint will be to evaluate the efficacy of laser-assisted hyaluronic acid delivery by fractional CO2 laser in facial skin remodeling. The secondary endpoint will be to confirm the safety of this protocol compared to a standard treatment by fractional CO2 laser.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 30 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients admitted to the Laser Center for facial skin remodeling,
- •aged from 30 to 70 years old,
- •with phototype I to IV (Fitzpatrick scale),
- •agreeing to participate in this study, signing the informed consent form
- •not fitting in any non-inclusion criterion
Exclusion Criteria
- •Pregnancy or breastfeeding,
- •active infection, history of oral or genital herpes
- •suspected neoplasia,
- •active inflammatory or infectious facial dermatitis,
- •oral retinoid treatment in the last 6 months,
- •phototype V or VI (Fitzpatrick scale)
- •age \<30 years or\> 70 years,
- •patients under guardianship or curatorship,
- •hemostasis disorders, thrombolytic or anticoagulant therapy, c
- •ongenital methaemoglobinaemia,
Outcomes
Primary Outcomes
Measurement of the improvment of one of the skin remodeling parameters (cutaneous texture, firmness, fine lines, radiance) using a scale from 0 to 10
Time Frame: 3 months
The primary judgment criterion will be the improvement at 3 months of at least one of the skin remodeling parameters (cutaneous texture, firmness, fine lines, radiance) at least 2 points greater (on a scale of 0 to 10) on fractional laser and hyaluronic acid-treated hemiface compared to fractional laser and control saline-treated hemiface.
Secondary Outcomes
No secondary outcomes reported