Open-Label Proof-of-Concept Study of CelluJuve® for the Treatment of Moderate to Severe Nasolabial Folds
Spiderwort Biotechnologies Inc.
Summary
Single-center, open-label proof of concept study assessing the safety and effectiveness of CelluJuve® for the treatment of moderate to severe NLFs
Description
All subjects will receive injections of CelluJuve® into both NLFs at Visit 1 (Baseline) and will receive touch-up treatments (if necessary) at Week 4 (Visit 2). Subjects will then be followed for 24 months after their last treatment (Visit 1 or Visit 2). Follow-up visits will occur every 3 months to collect safety and effectiveness data continuing through Month 24. The study will terminate after completion of the Month 24 visit. At each study visit, safety will be assessed through adverse event reporting and injection sites will be assessed for the common treatment responses (CTRs) that typi…
Eligibility
- Age range
- 22+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria 1. Male or female of any race, 22 years of age or older, who are seeking therapy for correction of moderate to severe NLFs. Female subjects of childbearing potential must have a negative UPT at Visit 1 and practice a reliable method of contraception throughout the study. 2. Moderate to severe bilateral NLFs with a severity grading of 3 or 4 as per the Wrinkle Severity Rating Scale (WSRS). Each NLF must have the same WSRS grade. 3. Healthy skin in the study treatment area and free of conditions or diseases that could interfere with study evaluations. 4. Able to follow study…
Interventions
- DeviceCelluJuve®
CelluJuve®
Location
- Skin Research Institute LLCCoral Gables, Florida