Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 6:40 PM
Ignite Modification Date:
2025-12-24 @ 6:40 PM
NCT ID:
NCT01463657
Brief Summary:
Patients presenting to the clinic for treatment of moderate to severe Nasolabial folds will be recruited to receive either ELAPR002b or ELAPR002d for the treatment of one Nasolabial fold and Juvéderm® Ultra Plus for the treatment of the second, opposite Nasolabial fold.
Detailed Description:
The treatment will be repeated on Day 29 (if required) and Day 57 (if required) to achieve optimum cosmetic results (OCR).
Each treatment will consist of up to 15 injections in total, each consisting of up to 0.1 ml of product, delivered to the mid to deep dermis of the skin of each Nasolabial fold using a 27G needle.
Each patient will receive the same preparation implanted as a bolus of 0.1mL at Day 1 into the mid-deep dermis of the skin of the medial aspect of the upper arm using a 27G needle, and two 2mm biopsies will be taken at the same visit on Day 57, Day 85 or Day 169 depending on randomisation for histopathology assessment.
Study:
NCT01463657
Study Brief:
Protocol Section:
NCT01463657