LifeSprout Lumina™ Study in the Treatment of Nasolabial Folds

September 9, 2022 updated by: LifeSprout, Inc.

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
118

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brussel, Belgium
        • UZ Brussels - Brussels University Hosptal
  • Portugal
      • Lisboa, Portugal
        • FACCIA
  • United Kingdom
      • London, United Kingdom
        • British Aesthetics
      • London, United Kingdom
        • PHP Aesthetic-PHP Wellness

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Subject aged at least 22 years.
  2. Subject has bilateral moderate or severe (grade 3 or 4) NLFs on the WSRS as scored by a live, masked evaluator.
  3. 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.
  4. Subject understands and accepts the obligation to present for all scheduled follow-up visits and is logistically able to meet all study requirements.
  5. 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.
  6. Subject willing to provide written informed consent for their participation in the study.

Exclusion Criteria:

  1. 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.
  2. 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.
  3. Subject is an employee or direct relative of an employee of the investigational site or study sponsor.
  4. Subject who has received surgery in the NLFs.
  5. 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).
  6. 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.
  7. Subject has a disorder that may impact wound healing such as connective tissue or immunosuppressive disorder.
  8. Subject has a history of precancerous lesions/skin malignancies.
  9. Subject has had an active skin disease within the past 6 months.
  10. Subject has scars, infection, rosacea, herpes, acne, blotches or other pathology in the NLFs.
  11. Subject has facial hair covering the nasolabial folds that they are unwilling to remove for study assessments.
  12. Subject has a past history of streptococcal disease or an active streptococcus infection.
  13. Subject has a past history of allergy or hypersensitivity to gram positive bacterial proteins.
  14. Subject is predisposed to keloidosis or hypertrophic scarring.
  15. Subject has a known history of hyper- or hypo-pigmentation in the NLFs.
  16. Subject with known allergy to poly (ε-caprolactone) microfibers, phosphate buffered saline, polyethylene glycol dithiol (PEG-SH), sodium-hyaluronate of bacterial origin, hyaluronic acid or streptococcal protein.
  17. Subject has a known history of multiple allergies, allergic/anaphylactic reactions including hypersensitivity to lidocaine or anesthetics of the amide type.
  18. Subject has a known bleeding disorder.
  19. Subject has received within the past week or plans to receive up to 1 month after treatment high-dose Vitamin E, aspirin, anti-inflammatories, antiplatelets, thrombolytics or any other medication that could increase the risk of bleeding.
  20. Subject has received any medication which, in the judgement of the investigator, may interfere with the study objectives.
  21. Subject has received within the past 12 months or plans to receive during the study any injections outside of those in the study protocol including non-permanent fillers (e.g., hyaluronic acid, CaHA) or neurotoxin on the face below the orbital rim (forehead is acceptable).
  22. Subject has received at any time or plans to receive during the study a permanent filler (e.g., polylactic acid, PMMA, silicone) on the face.
  23. Subject has received within the past 2 weeks or plans to receive during the study dermal resurfacing procedures or non-invasive skin tightening on the face.
  24. Subject has received in the past 2 weeks or plans to receive during the study prescription facial wrinkle therapies (RENOVA), topical steroids, skin irritating topical preparations, or self-tanning agents on the face.
  25. Subject has a known history of rapid weight loss/gain or plans to begin a weight loss program during the study (5% of body weight).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Lumina
Lumina Dermal Filler injected into 1 nasolabial fold. Optional Touch-up at 3 week visit with same.
Device: Study Product
up to 2cc per injection of filler placed into nasolabial fold.
Other Names:
  • Lumina
Active Comparator: Restylane Defyne
Restylane Defyne Dermal Filler injected into 1 nasolabial fold. Optional Touch-up at 3 week visit with same.
Device: Active Control
up to 2cc per injection of filler placed into nasolabial fold.
Other Names:
  • Restylane Defyne

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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)
6 month

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
WSRS other timepoint
Time Frame: 6 weeks, 3, 9, and 12 months
Individual endpoints at each timepoint of other than 6 month for mean change from baseline on the WSRS scale, as determined by the live, masked evaluator
6 weeks, 3, 9, and 12 months
WSRS proportions
Time Frame: 6 weeks, 3, 6, 9, and 12 months
proportion of NLFs in the Lumina™ treatment arm compared to that of NLFs in the Restylane® Defyne control arm with ≥1 point improvement from baseline on the WSRS
6 weeks, 3, 6, 9, and 12 months
Global Aesthetics Improvement Scale (GAIS) - Masked Evaluator
Time Frame: 6 weeks, 3, 6, 9, and 12 months
Individual endpoints for each rater type, as rated by the live, masked evaluator (5 point scale with 1 being most improvement and 5 being worsened)
6 weeks, 3, 6, 9, and 12 months
GAIS Subject
Time Frame: 6 weeks, 3, 6, 9, and 12 months
Individual endpoints for each rater type, as rated by the study subject.
6 weeks, 3, 6, 9, and 12 months
GAIS Investigator
Time Frame: 6 weeks, 3, 6, 9, and 12 months
Individual endpoints for each rater type, as rated by treating investigator
6 weeks, 3, 6, 9, and 12 months
FACE-Q (standardized questionnaire developed by Memorial Sloan Kettering) Appraisal of Nasolabial Folds Questionnaire
Time Frame: 6 weeks, 3, 6, 9, and 12 months
change from baseline for Lumina™ and Restylane® Defyne on the Subject FACE-Q Appraisal of Nasolabial Folds Questionnaire
6 weeks, 3, 6, 9, and 12 months
Visual Analog Scale (VAS) Pain
Time Frame: injection
pain assessment in NLFs treated with Lumina™ compared to NLFs treated with Restylane® Defyne at initial injection
injection
WSRS Photographics
Time Frame: 6 weeks, 3, 6, 9, and 12 months
Individual endpoints at each timepoint of 6 weeks, 3, 6, 9, and 12 months for mean change from baseline on the WSRS scale for NLFs treated with Lumina™ compared to NLFs treated with Restylane® Defyne, as rated by a photographic reviewer.
6 weeks, 3, 6, 9, and 12 months
Proportion WSRS photographic
Time Frame: 6 weeks, 3, 6, 9, and 12 months
proportion of NLFs in the Lumina™ treatment arm compared to that of NLFs in the Restylane® Defyne control arm with ≥1 point improvement from baseline on the WSRS, as determined by a photographic reviewer
6 weeks, 3, 6, 9, and 12 months

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Safety Endpoint
Time Frame: 13 month
to assess the rate and severity of adverse events from initial treatment through last study visit.
13 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
LifeSprout, Inc.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Health Policy Associates

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Sashank Reddy, M.D., LifeSprout, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 2, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 4, 2022

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 31, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 7, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 9, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 10, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 9, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CT001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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