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 @ 12:44 PM
Ignite Modification Date:
2025-12-24 @ 12:44 PM
NCT ID:
NCT01012661
Eligibility Criteria:
Inclusion Criteria:
* Is at least 18 years of age.
* Is a candidate for nasolabial fold treatment using Radiesse.
* Understands and accepts the obligation not to receive any other facial procedures in the lower half of the face for 1 month.
* Understands and accepts the obligation to present for all scheduled follow-up visits and is logistically able to meet all study requirements.
* Has approximately symmetrical nasolabial folds.
Exclusion Criteria:
* Has received any type of treatment or procedures including surgery in the nasolabial folds.
* Has received neurotoxins in the lower half of the face in the past 6 months.
* Has received hyaluronic acid, calcium hydroxylapatite (CaHA) or collagen injections in the lower half of the face within past 1 ½ years.
* Has received polylactic acid, polymethyl methacrylate (PMMA), silicone or any other permanent filler in the lower half of the face.
* Has nasolabial folds that are too severe to be corrected in one treatment session.
* Has a history of chronic or recurrent infection or inflammation that would preclude participation in the study.
* Has a known bleeding disorder or is receiving medication that will likely increase the risk of bleeding.
* Is female and of child bearing potential and is pregnant or not using acceptable method of birth control.
* Has had any history of hypersensitivity to Lidocaine or anesthetics of the amide type.
* Has a history of anaphylaxis or multiple severe allergies.
* Has received any investigational product within 30 days prior to study enrollment or is planning to participate in another investigation during the course of this study.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01012661
Study Brief:
Protocol Section:
NCT01012661