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 @ 1:02 PM
Ignite Modification Date:
2025-12-24 @ 1:02 PM
NCT ID:
NCT00653861
Eligibility Criteria:
Inclusion Criteria:
* Be male or female, 18 years of age or older
* Desire correction of moderate to severe nasolabial folds (NLFs)
* Have approximately symmetrical NLFs, i.e., both NLFs have the same pretreatment NLF severity score
Exclusion Criteria:
* Have undergone cosmetic facial procedures in the lower 2/3 of the face within 1 month prior to entry in the study or are planning to undergo these procedure during the study.
* Begin use of any new over-the-counter or prescription, oral or topical, anti-wrinkle products in the NLF area within 1 month prior to enrollment or are planning to begin use of such products during the study.
* Have undergone previous hyaluronic acid (HA)-based dermal filler treatments such that the total volume of HA injected within 12 months prior to study entry is within 5 mL of the recommended annual maximum volume for HA dermal fillers.
* Has ever received semi-permanent fillers or permanent facial implants anywhere in the face or neck, or is planning to be implanted with these products during the study.
* Have a history of anaphylaxis, multiple severe allergies, atopy, or allergy to lidocaine (or any amide-based anesthetic), hyaluronic acid products, or Streptococcal protein, or have plans to undergo desensitization therapy during the term of the study.
* Have an active inflammation, infection, cancerous or pre-cancerous lesion, or unhealed wound in the NLF area
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00653861
Study Brief:
Protocol Section:
NCT00653861