Laser-assisted Hyaluronic Acid Delivery by Fractional CO2 Laser in Facial Skin Remodeling

Not Applicable

Completed

• Conditions: Facial Skin Remodeling
• Interventions: Other: Laser-assisted hyaluronic acid delivery

• Registration Number: NCT03979586
• Lead Sponsor: Assistance Publique Hopitaux De Marseille

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 Timeline

• Study First Submitted: 2019-05-02
• Study First Submitted QC: 2019-06-06
• Study First Posted: 2019-06-07
• Study Start: 2019-09-17
• Primary Completion: 2019-09-25
• Study Completion: 2020-02-14
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-05
• Last Update Posted: 2020-11-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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%

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patient phototype I to IV	Laser-assisted hyaluronic acid delivery	The study will be conducted in the Laser Dermatological and Plastic Center of the Conception Hospital in Marseille. It will be a prospective, controlled, hemiface, single-blind, independent-evaluator pilot study of 20 patients, 30 to 70 years old, with phototype I to IV (Fitzpatrick scale). By this study in hemiface, each patient will be his own witness. Neither the patient nor the examining doctor will know the choice of the hemiface of application of hyaluronic acid. This will be a single-blind study with independent evaluator. Patients will be included for 3 months, and followed for a period of 3 months.

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Assistance Publique Hopitaux de Marseille; 🇫🇷 Marseille, France