LifeSprout Lumina™ Study in the Treatment of Nasolabial Folds

NCT04839484 | Active Not Recruiting FDA Device

• 1 other identifier: CT001
• Study Type: interventional
• Target: 118
• Locations: 3 countries
• Sites: 4

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.

Conditions

Nasolabial Fold

Outcome Measures

Primary Outcomes (1)

• primary effectiveness Wrinkle Severity Rating Scale (WSRS)

  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)

  6 month

Secondary Outcomes (9)

• WSRS other timepoint

  6 weeks, 3, 9, and 12 months

• WSRS proportions

  6 weeks, 3, 6, 9, and 12 months

• Global Aesthetics Improvement Scale (GAIS) - Masked Evaluator

  6 weeks, 3, 6, 9, and 12 months

• GAIS Subject

  6 weeks, 3, 6, 9, and 12 months

• GAIS Investigator

  6 weeks, 3, 6, 9, and 12 months

Other Outcomes (1)

• Safety Endpoint

  13 month

Study Arms (2)

Lumina

EXPERIMENTAL

Lumina Dermal Filler injected into 1 nasolabial fold. Optional Touch-up at 3 week visit with same.

Device: Study Product

Restylane Defyne

ACTIVE COMPARATOR

Restylane Defyne Dermal Filler injected into 1 nasolabial fold. Optional Touch-up at 3 week visit with same.

Device: Active Control

Interventions

Study Product DEVICE

up to 2cc per injection of filler placed into nasolabial fold.

Also known as: Lumina

Lumina

Active Control DEVICE

up to 2cc per injection of filler placed into nasolabial fold.

Also known as: Restylane Defyne

Restylane Defyne

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Subject has facial hair covering the nasolabial folds that they are unwilling to remove for study assessments.
• Subject has a past history of streptococcal disease or an active streptococcus infection.
• Subject has a past history of allergy or hypersensitivity to gram positive bacterial proteins.
• Subject is predisposed to keloidosis or hypertrophic scarring.
• Subject has a known history of hyper- or hypo-pigmentation in the NLFs.

Sponsors & Collaborators

• LifeSprout, Inc.: lead
• Health Policy Associates: collaborator

Study Sites (4)

UZ Brussels - Brussels University Hosptal

Brussels, Belgium

Location

FACCIA

Lisbon, Portugal

Location

British Aesthetics

London, United Kingdom

Location

PHP Aesthetic-PHP Wellness

London, United Kingdom

Location

Study Officials

• Sashank Reddy, M.D.

  LifeSprout, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: A blinded evaluator at each site who does not know what patient was treated with what product (per side) scores the patient. Photographic reviewers are also blinded to treatment.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Parallel assignment to product to different sides of face, per randomization code. At 12 months subjects may be retreated only with study product (partial cross over potential)

Study Record Dates

• First Submitted: March 31, 2021
• First Posted: April 9, 2021
• Study Start: March 2, 2021
• Primary Completion: September 4, 2022
• Study Completion: March 1, 2023
• Last Updated: September 10, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1); PT (1); GB (2)