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OpenTrials
Completed

NCT Number: NCT03979586

Laser-assisted Hyaluronic Acid Delivery by Fractional CO2 Laser in 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.

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Key information

Age range

30 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Assistance Publique Hopitaux de Marseille

Marseille, 13354, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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%

Treatment and study plan

Laser-assisted hyaluronic acid delivery

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.

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Assistance Publique Hopitaux De Marseille

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2020
First posted
Jun 7, 2019
Registry last updated
Nov 9, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.