HEALTHY SUBJECTS
Conditions
Interventions
Group 1: Deep dermal and subdermal injection of ELLANSE S in the Nasolabial Folds area
Sponsors
Sinclair Pharmaceuticals Ltd
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Healthy subject. 2.Sex: male and female. 3.Age: 18 years or older. 4.Subject seeking an aesthetic procedure. 5.Subject with moderate to severe nasolabial folds as determined by a WSRS score of 3 to 4 in both folds. 6.Subject willing to agree to have their photographs used for illustration purpose (the subjects can choose to have their photos anonymized). 7.Subject, psychologically able to understand the study related information and to give a written informed consent. 8.Subject having given freely and expressly his/her informed consent. 9.Subject able to comply with protocol requirements, as defined in the protocol. 10.Female subjects of childbearing potential should use a medically accepted contraceptive regimen since at least 12 weeks before the beginning of the study, during all the study and at least 1 month after the study end.
Exclusion criteria
Exclusion criteria: 1.Pregnant or nursing woman or planning a pregnancy during the study. 2.Subject who had been deprived of their freedom by administrative or legal decision or who is under guardianship. 3.Subject in a social or sanitary establishment. 4.Subject suspected to be non-compliant according to the investigator’s judgment. 5.Subject enrolled in another clinical trial on the same test zone within the four previous weeks and during the study period or being in an exclusion period for a previous study. 6.Subject is an employee or direct relative of an employee of the investigational site or study sponsor. 7.Subject suffering from a serious or progressive diseases, which, in the investigator’s judgment, put the subject at undue risk (whose diabetes, autoimmune pathology, cardiac pathologies, hepatic deficiency, epilepsy, porphyria, or other serious or progressive diseases at the Investigator’s discretion) 8.Subject having a previous history of cutaneous cancer or other cancer. 9.Subject with scars, infection, or other pathology on the injection sites. 10.Subject suffering from rosacea, herpes, acne, blotches on the injection sites (at the investigator appreciation). 11.Subject with a past history of streptococcal disease or with an active infection to streptococcus. 12.Subject predisposed to keloidosis or hypertrophic scarring. 13.Subject with known history of hyper- or hypo-pigmentation in the nasolabial folds 14.Subject with a known allergy to one of the ingredients of the tested products: polycaprolactone, carboxymethylcellulose or glycerol (as local anesthetic allergy). 15.Subject with coagulation troubles, abnormal bleeding, or other serious or progressive diseases at the Investigator’s discretion . 16.Subject with multiple allergies or anaphylactic shock history. 17.Subject with active skin disease within 6 months prior to study entry. 18.Subject with history of herpetic eruptions as this may be associated with reactivation of herpes. 19.Any medication which may interfere, at the interpretation of the investigator, with the study objectives in term of efficacy and safety tolerance. 20.Subject under an anti-coagulant treatment or beta-blockers in the weeks preceding the study and during the study. 21.Subject having taken high-dose Vitamin E, aspirin, anti-inflammatories, antiplatelet, thrombolytic during the week before the injection session and 1 month after treatment. 22.Subject having received chemotherapy agents or systemic corticosteroids 3 months before enrollment. 23.Subject having received permanent implants in the area. 24.Subject having done injections of semi-permanent filling products (Radiesse or ellansé) within 12 months before enrollment. 25.Subject having done Hyaluronic Acid injections or Botulinum toxin injections on the face or had any aesthetic procedure within 6 months before enrollment. 26.Subject with subcutaneous retaining structure on the face (meshing, gold strands,…). 27.Subject having done a peeling, a laser treatment or ultrasound treatment in the face in the 6 previous months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluation of the clinical safety of the product ELLANSE®-S with a reporting of the immediate and delayed adverse events until 18 months after treatment and clinical evaluation of the percentage of subjects with an improvement in nasolabial folds severity using the Wrinkle Severity Rating Scale (WSRS) superior to 1 at M12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluation of the clinical safety of the product ELLANSE®-S with the Injection Site Reactions Scale (ISR) completed by the Investigator at each visit and by the patient from D1 to D7 at home. Clinical evaluation of the nasolabial folds severity using the Wrinkle Severity Rating Scale (WSRS), rated by the Investigator, of aesthetic improvement by the evaluator and the subject using the Global Aesthetic Improvement Scale (GAIS) at each timepoint. Analysis of the Investigator’s answers to a subjective evaluation questionnaire on their appreciation of the injection quality (D0) and of the subject’s answers to a subjective evaluation questionnaire concerning their satisfaction after treatment with the tested product (D7, M1, M3, M6 and M12). Illustration of the product’s visual effect by realisation of macrophotographs at each visit. Blinded evaluation of the pictures on the WSRS score by an independent assessor or panel | — |
Countries
France, Germany
Contacts
Public ContactMarie-Odile CHRISTEN
Sinclair Pharmaceuticals Ltd
Outcome results
None listed