An Interventional Study to Evaluate the Safety and Performance of Crosslinked Hyaluronic Acid Hyd… (NCT05853224) | Clinical Trial Compass
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An Interventional Study to Evaluate the Safety and Performance of Crosslinked Hyaluronic Acid Hydrogel
Italy72 participantsStarted 2022-04-02
Plain-language summary
The aim of this interventional, pre-market, double- blinded, controlled, two stages study is to evaluate the performance and safety of Crosslinked Hyaluronic Acid (CLHA) Hydrogel (with and without Lidocaine) for the Treatment of Soft Tissue Deficits.
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion Criteria:
* Patient Informed consent form (ICF) signed
* Female and male subjects aged 18-65 years and in good general health;
* Subjects with Soft Tissue Deficits of the face requiring midface volume restoration;
* Willingness to follow all study procedures, including attending all site visits, tests, and examinations;
* Agreeing to present at each study visit without makeup;
* Accepting to not change their habits regarding food, physical activity, make-up use, facial cosmetics, and cleansing products;
* Willingness to not undergo other procedures involving permanent and nonpermanent aesthetic correction (e.g. chemical peel, dermabrasion, ablative laser resurfacing), non-invasive skin-tightening, botulinum toxin injections, dermal filler injections, mesotherapy, or fat injections during the study period of 12 months;
* Willing to follow indications to not be exposed to make-up, excessive heat (sun, UV tanning sessions, or laser), and extreme temperatures (intense cold, sauna, hammam, etc.) after the treatment and until the complete absorption of swelling and reddening.
Exclusion Criteria:
* Presence of recurrent facial/labial herpes;
* Presence of tendon, bone, or muscular implants near the area of intervention;
* Subjects previously treated with fillers anywhere in the face or neck;
* Subjects who have undergone invasive face or neck surgery;
* Ongoing cutaneous allergies and history of hyper- or hypo-pigmentation in the mouth area, keloid formation, or hypertr…
What they're measuring
1
Evaluation of the CLHA performance in the nasolabial folds
Timeframe: 6 months
2
Evaluation of the CLHA performance in the perioral lines