RejuvenationNCT02910492

Study of a Novel Laser for Skin Rejuvenation

A study testing enLighten Laser in people with Rejuvenation, run by Cutera Inc. at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

Single-center study to evaluate the safety and efficacy of an investigational version of the enlighten™ 670nm laser for photo-rejuvenation. Read more about this study

Who is it for?: Ages 18 to 75 yearsHealthy volunteers can take part
Conditions the study is for: Rejuvenation
What is being tested?: enLighten Laser
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 10 participants
Where: 2 sitesUnited States
Study dates: Sep 2016to Mar 2017
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 18 to 75 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Female or Male, 18 to 75 years of age (inclusive).
Fitzpatrick Skin Type I - VI.
Desires photo-rejuvenation of the skin or improvement in the appearance of acne scarring.
Subject has visible signs of acne scarring or moderate sun-damaged and/or aging skin in the treatment area with visible areas acne lesions and scars, fine rhytides, lentigines or pigmentation, diffused redness erythema and skin texture
Subject must be able to read, understand and sign the Informed Consent Form.
Must be willing and able to adhere to the treatment and follow-up schedule and post-treatment care instructions.

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Willing to have very limited sun exposure and use an approved sunscreen of SPF 50 or higher on the treatment area every day for the duration of the study, including the follow-up period.
Willing to have digital photographs taken of the treatment area and agree to use of photographs for presentation, educational or marketing purposes.
Agree to not undergo any other procedure(s), including injectable agents, for skin rejuvenation during the study and has no intention of having such procedures performed during the course of the study.
Post-menopausal or surgically sterilized, or using a medically acceptable form of birth control at least 3 months prior to enrollment and during the entire course of the study, and no plans to become pregnant.

Who cannot join

Participation in a clinical trial of another drug, or device administered to the target area, during the study.
Any type of prior cosmetic treatment to the target area within 6 months of study participation, such as laser or light-based procedures or surgery.
Prior injection of botulinum toxin, collagen, hyaluronic acid filler or other dermal filler within 6 months of study participation.
History of malignant tumors in the target area.
Skin abnormalities in the target area, e.g., cuts, scrapes, wounds, large moles.
Pregnant and/or breastfeeding.

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Having an infection, dermatitis or a rash in the treatment area.
Significant concurrent illness, such as diabetes mellitus or cardiovascular disease, e.g., uncontrolled hypertension.
History of keloid scarring, hypertrophic scarring or of abnormal wound healing.
History of immunosuppression/immune deficiency disorders or currently using immunosuppressive medications per investigator's discretion.
History of vitiligo, eczema, or psoriasis.
History of connective tissue disease, such as systemic lupus erythematosus or scleroderma.
History of seizure disorders due to light.
Any use of medication that is known to increase sensitivity to light according to Investigator's discretion.
History of disease stimulated by heat, such as recurrent herpes simplex and/or herpes zoster (shingles) in the treatment area, unless treatment is conducted following a prophylactic regimen
History of pigmentary disorders, particularly tendency for hyper- or hypo-pigmentation.
Systemic use of retinoid, such as isotretinoin, as applicable, within 6 months of study participation.
Topical use of retinoid, such as isotretinoin, as applicable, on the treatment area within 1 month of participation.
Anytime in life, having have used gold therapy (gold salts) for disorders such as rheumatologic disease or lupus.
Excessively tanned in areas to be treated or unable/unlikely to refrain from tanning during the study.
Current smoker or history of smoking within 6 months of study participation.
As per the Investigator's discretion, any physical or mental condition which might make it unsafe for the subject to participate in this study.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Cutera Research Clinic
Brisbane, California, 94005
Connecticut Skin Institute
Stamford, Connecticut, 06905

Other trials in United States

About this study

Official title: A Single-Center, Open-Label Exploratory Study of a Novel Laser for Skin Rejuvenation

Single-center study to evaluate the safety and efficacy of an investigational version of the enlighten™ 670nm laser for photo-rejuvenation.

Read the detailed description

A single-center prospective, open-label uncontrolled exploratory study to evaluate the safety and efficacy of an investigational version of the enlighten™ 670nm laser for photo-rejuvenation.

Subjects will receive laser treatments, and will be followed at 12 weeks post-final treatment. In addition, after each treatment, subjects will complete a 3 day post treatment phone follow-up.

Conditions: Rejuvenation
Being tested: enLighten Laser

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

enLighten LaserDevice
Dual-pulse duration laser for the treatment of skin rejuvenation

Study groups in NCT02910492
Study group	Role	What they receive
Investigational Enlighten Device	Experimental	Laser treatment for facial skin rejuvenation with the experimental enLighten Laser Receives: Device: enLighten Laser

What is being measured

The primary outcome is the main question the study is designed to answer.

Degree of Improvement as Assessed by the Investigator (Physician's Global Assessment of Improvement).
Degree of improvement in the treated area at 12 weeks post-final treatment as assessed by the Investigator (Physician's Global Assessment of Improvement).
Higher scores indicate better outcomes 4= Very Significant Clearing 3=Significant Clearing 2= Moderate Clearing
1= Mild Clearing 0= No Clearing
Measured: 12 weeks post-final treatment, an average of 4 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2016Mar 2017

First posted22 Sep 2016 (estimated)
Study startSep 2016
Primary completionMar 2017
Study completionMar 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for RejuvenationStudies 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: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 10 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02910492
Sponsor's protocol ID: C-16-EN12
Status last verified: Sep 2023
First submitted: 16 Sep 2016
Last updated: 15 Sep 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
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Autologous Hair Follicle-Derived Secretome and Platelet-Rich Plasma for Premature Ovarian Insufficiency
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Recruiting
Ultraformer MPT Combined With Fractional CO2 Versus Fractional CO2 Alone for Facial Rejuvenation
Skin Aging
RecruitingPhase 4
PLLA and CaHA-R for Aesthetic Rejuvenation
Aesthetic
Enrolling by invitationEarly Phase 1
Systemic and Topical Geroprotective Rejuvenation Assessed by START/REST Aging Clocks
Aging

All Rejuvenation trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Single-Center, Open-Label Exploratory Study of a Novel Laser for Skin Rejuvenation
ClinicalTrials.gov ID: NCT02910492
Acronym / sponsor ID: C-16-EN12
Conditions: Rejuvenation
Study type: Interventional
Recruitment status: Completed
Enrolment: 10 participants (actual)
Lead sponsor: Cutera Inc.Industry (pharma, biotech, devices)
Study start: Sep 2016
Primary completion: Mar 2017 (actual)
Study completion: Mar 2017 (actual)
First posted: 22 Sep 2016 (estimated)
Results: Posted 15 Sep 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Single-center study to evaluate the safety and efficacy of an investigational version of the enlighten™ 670nm laser for photo-rejuvenation.

Detailed description

A single-center prospective, open-label uncontrolled exploratory study to evaluate the safety and efficacy of an investigational version of the enlighten™ 670nm laser for photo-rejuvenation.

Subjects will receive laser treatments, and will be followed at 12 weeks post-final treatment. In addition, after each treatment, subjects will complete a 3 day post treatment phone follow-up.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Investigational Enlighten Device	Experimental	Device: enLighten LaserLaser treatment for facial skin rejuvenation with the experimental enLighten Laser

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

Female or Male, 18 to 75 years of age (inclusive).
Fitzpatrick Skin Type I - VI.
Desires photo-rejuvenation of the skin or improvement in the appearance of acne scarring.
Subject has visible signs of acne scarring or moderate sun-damaged and/or aging skin in the treatment area with visible areas acne lesions and scars, fine rhytides, lentigines or pigmentation, diffused redness erythema and skin texture
Subject must be able to read, understand and sign the Informed Consent Form.

Key exclusion criteria (22 listed)

Participation in a clinical trial of another drug, or device administered to the target area, during the study.
Any type of prior cosmetic treatment to the target area within 6 months of study participation, such as laser or light-based procedures or surgery.
Prior injection of botulinum toxin, collagen, hyaluronic acid filler or other dermal filler within 6 months of study participation.
History of malignant tumors in the target area.
Skin abnormalities in the target area, e.g., cuts, scrapes, wounds, large moles.

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
enLighten LaserDual-pulse duration laser for the treatment of skin rejuvenation	Device	Investigational Enlighten Device

Primary outcome

Degree of Improvement as Assessed by the Investigator (Physician's Global Assessment of Improvement).
Time frame: 12 weeks post-final treatment, an average of 4 months
Degree of improvement in the treated area at 12 weeks post-final treatment as assessed by the Investigator (Physician's Global Assessment of Improvement). Higher scores indicate better outcomes 4= Very Significant Clearing 3=Significant Clearing 2= Moderate Clearing 1= Mild Clearing 0= No Clearing

Results and safety

Results posted to the registry on 15 Sep 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Investigational Enlighten Device	10	4

Primary outcome: Degree of Improvement as Assessed by the Investigator (Physician's Global Assessment of Improvement).

Time frame: 12 weeks post-final treatment, an average of 4 months. Mean (Standard Deviation). Unit: score on a scale

Measure	Investigational Enlighten Device n = 4
Value	1.7 (1.5)

Adverse events

Time frame: 12 weeks post final treatment, up to 6 months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Investigational Enlighten Device	0 of 10 (0%)	10 of 10 (100%)	0 of 10

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Rejuvenation

RecruitingObservational study
Proteomic and Biological Characterisation of Plasma for the Study of Changes Following Ovarian Reactivation Treatment
Poor Ovarian Response, Ovarian Reactivation
RecruitingPhase 2
Autologous Hair Follicle-Derived Secretome and Platelet-Rich Plasma for Premature Ovarian Insufficiency
Premature Ovarian Insufficiency, POI
Recruiting
Ultraformer MPT Combined With Fractional CO2 Versus Fractional CO2 Alone for Facial Rejuvenation
Skin Aging
RecruitingPhase 4
PLLA and CaHA-R for Aesthetic Rejuvenation
Aesthetic
Enrolling by invitationEarly Phase 1
Systemic and Topical Geroprotective Rejuvenation Assessed by START/REST Aging Clocks
Aging

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.

Stephen Ronan, MD principal investigator

Cutera Research Center

Omar Ibrahimi, MD principal investigator

Connecticut Skin Institute

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing enLighten Laser in people with Rejuvenation, run by Cutera Inc. at 2 sites in United States.

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 10 inclusion and 22 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: finished, as of the sponsor's last update on 15 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. 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?

Yes. Results are posted in the registry (first posted 15 Sep 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Degree of Improvement as Assessed by the Investigator (Physician's Global Assessment of Improvement). (time frame: 12 weeks post-final treatment, an average of 4 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02910492.

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 15 Sep 2023.