Facial Skin Remodeling
Conditions
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.
Interventions
OTHERLaser-assisted hyaluronic acid delivery
The facial skin remodeling corresponds to a request for repair treatment on the stigmas of heliodermia, irregularity of cutaneous texture, dyschromias, loss of radiance of the complexion, fine lines, as well as on the fine scars of the face for example, the finely depressed cicatrices sequellaires acne.
Sponsors
Assistance Publique Hopitaux De Marseille
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
30 Years to 70 Years
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, * porphyria, * known hypersensitivity to hyaluronic acid, local anesthetics of the amide group or to any other component of Anesderm cream Ge 5%
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Measurement of the improvment of one of the skin remodeling parameters (cutaneous texture, firmness, fine lines, radiance) using a scale from 0 to 10 | 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. |
Countries
France
Outcome results
None listed