Laser-assisted Hyaluronic Acid Delivery by Fractional CO2 Laser in Facial Skin Remodeling
November 5, 2020 updated by: Assistance Publique Hopitaux De Marseille
Intradermal Delivery of Fractional CO2 Laser-assisted Hyaluronic Acid 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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
20
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Marseille, France, 13354
- Assistance Publique Hôpitaux de Marseille
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
30 years to 70 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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EXPERIMENTAL: 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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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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
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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.
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3 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
September 17, 2019
Primary Completion (ACTUAL)
September 25, 2019
Study Completion (ACTUAL)
February 14, 2020
Study Registration Dates
First Submitted
May 2, 2019
First Submitted That Met QC Criteria
June 6, 2019
First Posted (ACTUAL)
June 7, 2019
Study Record Updates
Last Update Posted (ACTUAL)
November 9, 2020
Last Update Submitted That Met QC Criteria
November 5, 2020
Last Verified
November 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2019-17
- RC12_0036 (REGISTRY: APHM)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.