Nasolabial FoldNCT04839484
LifeSprout Lumina™ Study in the Treatment of Nasolabial Folds
A study testing Study Product in people with Nasolabial Fold, run by LifeSprout, Inc. at 4 sites in 3 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 22 years and olderHealthy volunteers can take part
- Conditions the study is for
- Nasolabial Fold
- What is being tested?
- Study Product
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 118 participants
- Where
- 4 sitesin 3 countries
- Study dates
- 2 Mar 2021to Mar 2023
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 25Show fewer
- 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.
- 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.
- Subject has a known history of multiple allergies, allergic/anaphylactic reactions including hypersensitivity to lidocaine or anesthetics of the amide type.
- Subject has a known bleeding disorder.
- 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.
- Subject has received any medication which, in the judgement of the investigator, may interfere with the study objectives.
- 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).
- 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.
- 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.
- 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.
- 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).
Trial locations and contacts
4 sites in 3 countries.
4 sites in 3 countries
United Kingdom2 sites
British Aesthetics
London
PHP Aesthetic-PHP Wellness
London
About this study
Official title: 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.
- Conditions
- Nasolabial Fold
- Being tested
- Study Product, Active Control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Study ProductDevice
Also called Lumina
up to 2cc per injection of filler placed into nasolabial fold.
Active ControlDevice
Also called Restylane Defyne
up to 2cc per injection of filler placed into nasolabial fold.
| Study group | Role | What they receive |
|---|---|---|
| Lumina | Experimental | Lumina Dermal Filler injected into 1 nasolabial fold. Optional Touch-up at 3 week visit with same. Receives: 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. Receives: Device: Active Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 6 month
Secondary outcomes (9)
WSRS other timepoint
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
Measured: 6 weeks, 3, 9, and 12 months
WSRS proportions
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
Measured: 6 weeks, 3, 6, 9, and 12 months
Global Aesthetics Improvement Scale (GAIS) - Masked Evaluator
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)
Measured: 6 weeks, 3, 6, 9, and 12 months
GAIS Subject
Individual endpoints for each rater type, as rated by the study subject.
Measured: 6 weeks, 3, 6, 9, and 12 months
GAIS Investigator
Individual endpoints for each rater type, as rated by treating investigator
Measured: 6 weeks, 3, 6, 9, and 12 months
FACE-Q (standardized questionnaire developed by Memorial Sloan Kettering) Appraisal of Nasolabial Folds Questionnaire
change from baseline for Lumina™ and Restylane® Defyne on the Subject FACE-Q Appraisal of Nasolabial Folds Questionnaire
Measured: 6 weeks, 3, 6, 9, and 12 months
Visual Analog Scale (VAS) Pain
pain assessment in NLFs treated with Lumina™ compared to NLFs treated with Restylane® Defyne at initial injection
Measured: injection
WSRS Photographics
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.
Measured: 6 weeks, 3, 6, 9, and 12 months
Proportion WSRS photographic
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
Measured: 6 weeks, 3, 6, 9, and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2021
- Study start2 Mar 2021
- Primary completion4 Sep 2022
- Study completionMar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasolabial FoldStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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)
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 118 participants (estimated)
Sponsor and investigators
- Lead sponsor
- LifeSprout, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Health Policy Associates
- Responsible party
- Sponsor
- Investigators
- Sashank Reddy, M.D., Study director, LifeSprout, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04839484
- Sponsor's protocol ID
- CT001
- Status last verified
- Aug 2022
- First submitted
- 31 Mar 2021
- Last updated
- 10 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Controlled, Multi-center Study of the Safety and Effectiveness of Lumina™ in the Treatment of Nasolabial Folds
- ClinicalTrials.gov ID
- NCT04839484
- Acronym / sponsor ID
- CT001
- Conditions
- Nasolabial Fold
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 118 participants (estimated)
- Lead sponsor
- LifeSprout, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Health Policy Associates
- Study start
- 2 Mar 2021 (actual)
- Primary completion
- 4 Sep 2022 (actual)
- Study completion
- Mar 2023 (estimated)
- First posted
- 9 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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)
| Arm | Type | Receives |
|---|---|---|
| Lumina | Experimental | Device: Study ProductLumina Dermal Filler injected into 1 nasolabial fold. Optional Touch-up at 3 week visit with same. |
| Restylane Defyne | Active comparator | Device: Active ControlRestylane Defyne Dermal Filler injected into 1 nasolabial fold. Optional Touch-up at 3 week visit with same. |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (25 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Study ProductAlso: Luminaup to 2cc per injection of filler placed into nasolabial fold. | Device | Lumina |
| Active ControlAlso: Restylane Defyneup to 2cc per injection of filler placed into nasolabial fold. | Device | Restylane Defyne |
Primary outcome
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)
9 secondary outcomes
WSRS other timepoint
Time frame: 6 weeks, 3, 9, and 12 months
WSRS proportions
Time frame: 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
GAIS Subject
Time frame: 6 weeks, 3, 6, 9, and 12 months
GAIS Investigator
Time frame: 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
Visual Analog Scale (VAS) Pain
Time frame: injection
WSRS Photographics
Time frame: 6 weeks, 3, 6, 9, and 12 months
Proportion WSRS photographic
Time frame: 6 weeks, 3, 6, 9, and 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sashank Reddy, M.D. study director
LifeSprout, Inc.
4 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Study Product in people with Nasolabial Fold, run by LifeSprout, Inc. at 4 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 10 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United Kingdom, Belgium, Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
primary effectiveness Wrinkle Severity Rating Scale (WSRS) (time frame: 6 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2022.