A Prospective, Randomized, Controlled, Multi-center Study of the Safety and Effectiveness of Lumina™ in the Treatment of Nasolabial Folds

LifeSprout, Inc.4 sites in 3 countries118 target enrollmentMarch 2, 2021

ConditionsNasolabial Fold

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Nasolabial Fold
Sponsor: LifeSprout, Inc.
Enrollment: 118
Locations: 4
Primary Endpoint: primary effectiveness Wrinkle Severity Rating Scale (WSRS)
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The study will be a prospective, randomized, split-face, double blind, controlled, clinical trial to evaluate the safety and effectiveness of Lumina™ for the treatment of Nasolabial Folds (NLFs). Subjects will be randomized to receive treatment (Lumina™) in one NLF and control (Restylane® Defyne) in the contra-lateral NLF. 118 subjects will be treated.

Registry

clinicaltrials.gov

Start Date

March 2, 2021

End Date

March 2023

Last Updated

3 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

LifeSprout, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Subject aged at least 22 years.
•Subject has bilateral moderate or severe (grade 3 or 4) NLFs on the WSRS as scored by a live, masked evaluator.
•Subject willing to abstain from other facial aesthetic procedures in the NLFs through the 12 month (13 month if retreatment at 12 months) follow-up visit which could interfere with treatment outcomes (e.g. facial fillers, skin laser and radiofrequency therapy such as Thermage, chemical re-surfacing, dermabrasion, Botox injections, aesthetic facial surgery, other facial treatments in the NLFs.
•Subject understands and accepts the obligation to present for all scheduled follow-up visits and is logistically able to meet all study requirements.
•Subject with facial hair which may obstruct the assessment of the treatment area, must be agreeable with non-laser removal of facial hair prior to assessment visits.
•Subject willing to provide written informed consent for their participation in the study.

Exclusion Criteria

•Subject is a female of childbearing potential (e.g., not postmenopausal for at least one year or has not had a hysterectomy or tubal ligation) not using medically effective birth control (e.g., hormonal methods in use at least 30 days prior to injection or barrier methods such as condom and spermicide in use at least 14 days prior to injection) or is pregnant, lactating, or plans to become pregnant during the study.
•Subject has participated in a clinical study in which an investigational device or drug was received in the 30 days prior to screening or plans to enroll in such a study during the course of the current study.
•Subject is an employee or direct relative of an employee of the investigational site or study sponsor.
•Subject who has received surgery in the NLFs.
•Subject has a serious or progressive disease, which, in the investigator's judgment, puts the subject at undue risk (e.g. uncontrolled diabetes, autoimmune disease, cardiac pathologies).
•Subject has an acute inflammatory process or infection, or history of chronic or recurrent infection or inflammation with the potential to interfere with the study results or increase the risk of adverse events.
•Subject has a disorder that may impact wound healing such as connective tissue or immunosuppressive disorder.
•Subject has a history of precancerous lesions/skin malignancies.
•Subject has had an active skin disease within the past 6 months.
•Subject has scars, infection, rosacea, herpes, acne, blotches or other pathology in the NLFs.

Outcomes

Primary Outcomes

primary effectiveness Wrinkle Severity Rating Scale (WSRS)

Time Frame: 6 month

The mean change from baseline of NLFs in the Lumina™ treatment arm will be compared to that of NLFs in the Restylane® Defyne control arm. (5 point scale with 1 being no visible NLF and 5 being extreme, deep and long NLFs)

Secondary Outcomes

WSRS other timepoint(6 weeks, 3, 9, and 12 months)
WSRS proportions(6 weeks, 3, 6, 9, and 12 months)
GAIS Subject(6 weeks, 3, 6, 9, and 12 months)
Proportion WSRS photographic(6 weeks, 3, 6, 9, and 12 months)
Global Aesthetics Improvement Scale (GAIS) - Masked Evaluator(6 weeks, 3, 6, 9, and 12 months)
GAIS Investigator(6 weeks, 3, 6, 9, and 12 months)
FACE-Q (standardized questionnaire developed by Memorial Sloan Kettering) Appraisal of Nasolabial Folds Questionnaire(6 weeks, 3, 6, 9, and 12 months)
Visual Analog Scale (VAS) Pain(injection)
WSRS Photographics(6 weeks, 3, 6, 9, and 12 months)