Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:40 PM
Ignite Modification Date:
2025-12-24 @ 6:40 PM
NCT ID:
NCT01463657
Eligibility Criteria:
Inclusion Criteria:
* Aged 25 - 65 years
* Male or Female
* Moderate to severe NLFs scored equally as a 3 or 4 out of 5 on both sides of the face using the WAS scale
* Good general health status
* Able to give informed consent
Exclusion Criteria:
* Clinically significant abnormalities of haematology or biochemistry testing
* Bleeding diathesis, anticoagulant drugs, thrombocytopenia or clinically significant prolonged bleeding time
* Chronic use of aspirin, other non-steroidal anti-inflammatory drugs or other anti-platelet agents
* Allergy to local anaesthetics
* Active infection at the treatment site
* Treatment of either NLF other than with a hyaluronic acid (HA) dermal filler and treatment with a HA dermal filler within 18 months of enrolment
* Any serious medical condition which in the opinion of the investigator would have a strong possibility of requiring systemic corticosteroid medication
* Pregnancy/lactation
* History of keloid formation
* Systemic corticosteroids within last 12 weeks
* Diabetes or metabolic disorders
* A history of anaphylaxis or allergic reactions including any known hypersensitivity to Hyaluronic acid or lidocaine
* Sensitivity to Juvéderm® Ultra Plus or Juvéderm® products.
* Participation in any other clinical trial one month prior to treatment and for the duration of the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
25 Years
Maximum Age:
65 Years
Study:
NCT01463657
Study Brief:
Protocol Section:
NCT01463657