An interventional study of Laser-assisted hyaluronic acid delivery in Facial Skin Remodeling, sponsored by Assistance Publique Hopitaux De Marseille. Completed at 1 site in France. Open to participants aged 30 Years to 70 Years. Per ClinicalTrials.gov, last updated 2020-11-09.
Sponsored by Assistance Publique Hopitaux De Marseille · Not applicable, Interventional, and Treatment
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.
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.
218 studies on the registry are indexed under Facies; 35 are open to participants now.
This study's enrollment of 20 is below the median of 40 across 162 interventional studies indexed under Facies.
Browse Facies studies →Assistance Publique Hopitaux De Marseille is the lead sponsor of 686 studies on the registry; 148 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
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.
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.
Time frame: 3 months
This study is completed, as verified in Nov 2020. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Assistance Publique Hopitaux De Marseille