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

Facial Skin Remodeling Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03979586
• Other study ID #: 2019-17
• Secondary ID: RC12_0036
• Status: Completed
• Phase: N/A
• Start date: September 17, 2019
• Est. completion date: February 14, 2020

Study information

• Verified date: November 2020
• Source: Assistance Publique Hopitaux De Marseille
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: February 14, 2020
• Est. primary completion date: September 25, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 70 Years

Eligibility

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%

Related Conditions & MeSH terms

• Facial Skin Remodeling
• Facies

Intervention

Other:
• Laser-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.

Locations

Country	Name	City	State
France	Assistance Publique Hopitaux de Marseille	Marseille

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique Hopitaux De Marseille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measurement of the improvment of one of the skin remodeling parameters (cutaneous texture, firmness, fine lines, radiance) using a scale from 0 to 10	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.	3 months