The Evaluation of Efficacy and Safety of Stylage® XL Lidocaïne for the Restoration and/or Augment… (NCT04166292) | Clinical Trial Compass
CompletedNot Applicable
The Evaluation of Efficacy and Safety of Stylage® XL Lidocaïne for the Restoration and/or Augmentation of Facial Volume
France40 participantsStarted 2019-11-21
Plain-language summary
Stylage® XL Lidocaïne is a CE-marketed hyaluronic acid gel indicated for the restoration or augmentation of facial volume by injection into the deep dermis or subcutaneously. Lidocaine hydrochloride is intended to reduce the pain associated with the injection.
In this study 40 healthy subjects between the age of 30 and 65 years, presenting a volume deficit on the face as evaluated by the investigator at inclusion in the study, who have given his/her informed consent and met all the eligibility criteria, will be enrolled.
Subjects will come to a total of 6 visits over a period of 18 months and a screening visit prior to baseline injection. The facial volume variation after baseline injection will be assessed. Treatment responders rate, Global Aesthetic Improvement, volume on the cheekbones, volume on the chin and chin angle (for applicable subjects), subject's satisfaction and safety will be also assessed.
Who can participate
Age range30 Years – 65 Years
SexALL
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Inclusion Criteria:
* Healthy Subject;
* Sex: male or female;
* Age: between 30 and 65 years;
* Subject having given freely and expressly his informed consent;
* Subject requiring injection on the cheekbones (upper part of the cheek);
* Subject with grade from 3 to 5 on the Facial Volume Loss Scale (FVLS);
* Subject, psychologically able to understand the study related information and to give a written informed consent;
* Subject affiliated to a health social security system;
* Female of childbearing potential should use a medically accepted contraceptive regimen since at least 12 weeks before the beginning of the study and during all the study;
* Subject agreeing to keep their usual cleansing / care products during the whole study period;
* Subject agreeing to apply a Sun Protection Factor (SPF) 50 cream during non-intensive exposure to sunlight.
Exclusion Criteria:
In terms of population
* Pregnant or nursing woman or planning a pregnancy during the study;
* Subject with a scar, moles or anything on the face which might interfere with the evaluation;
* Subject who had been deprived of their freedom by administrative or legal decision or who is under guardianship;
* Subject in a social or sanitary establishment;
* Subject participating to another research on human beings or who is in an exclusion period of one;
* Subject having received 4500 euros indemnities for participation in researches involving human beings in the 12 previous months, including participation in the …