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

NCT ID: NCT03979586

Last Updated: 2020-11-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-17

Study Completion Date

2020-02-14

Brief Summary

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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

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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.

Conditions

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Facial Skin Remodeling

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Patient phototype I to IV

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.

Group Type EXPERIMENTAL

Laser-assisted hyaluronic acid delivery

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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%
Minimum Eligible Age

30 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assistance Publique Hopitaux De Marseille

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Assistance Publique Hopitaux de Marseille

Marseille, , France

Site Status

Countries

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France

Other Identifiers

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RC12_0036

Identifier Type: REGISTRY

Identifier Source: secondary_id

2019-17

Identifier Type: -

Identifier Source: org_study_id