CelluJuve® for the Treatment of Moderate to Severe NLFs
ConditionNasolabial Fold Wrinkles
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age22+
SponsorSpiderwort Biotechnologies Inc.
About this trial
Single-center, open-label proof of concept study assessing the safety and effectiveness of CelluJuve® for the treatment of moderate to severe NLFs
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
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.
Healthy skin in the study treatment area and free of conditions or diseases that could interfere with study evaluations.
Able to follow study instructions and complete all required visits.
Disqualifiers
Female subjects that are pregnant, breast-feeding, or of childbearing potential and not practicing reliable contraception.
A condition or situation that puts the subject at significant risk, may confound the study results, or may significantly interfere with subjects' study participation.
Study staff or close relative to study staff (e.g., parents, children, siblings, or spouse).
Abnormal visual tests (i.e., Snellen acuity test worse than 20/40 with corrections, if applicable), abnormal confrontational visual field test, and/or abnormal ocular motility test.
Trial design
Design model
Single group
Treatments tested in this trial
CelluJuve®
DeviceCelluJuve®
Treatment groups
12 Participants
are divided into 1 treatment groupGroup A: CelluJuve®Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Wrinkle Severity Rating Scale
5-point static scale ranging from 1-Absent to 5-Extreme
Time frame
2 months, 3 months, 6 months, 9 months, 12 months, 15 months, 18 months, 21 months, 24 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov