WrinklesNCT02888626
Study of a Novel Microlens Array Device for Skin Rejuvenation
A study testing Microlens Array in people with Wrinkles and Scars, run by Cutera Inc. at 1 site in United States.
Trial summary
A single-center prospective, open-label uncontrolled pilot study. Subjects will receive laser treatments and will be followed at 12 weeks post-final treatment. Read more about this study
- Who is it for?
- Ages 20 to 75 yearsHealthy volunteers can take part
- What is being tested?
- Microlens Array
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2016to 6 Feb 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 20 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Female or Male, 20 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 of fine rhytides, pigmentation, erythema or telangiectasia.
- 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.
- 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.
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- 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, within 6 months prior to enrollment or 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, scars, 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.
- Suffering from coagulation disorders or taking prescription anticoagulation medications.
- History of keloid scarring, hypertrophic scarring or of abnormal wound healing.
- History of immunosuppression/immune deficiency disorders or currently using immunosuppressive medications.
- 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 radiation to the treatment area or undergoing systemic chemotherapy for the treatment of cancer.
- History of pigmentary disorders, particularly tendency for hyper- or hypo-pigmentation.
- Systemic use of retinoid, such as isotretinoin, or corticosteroid, as applicable, within 6 months of study participation.
- Topical use of retinoid, such as isotretinoin, corticosteroid or hydroquinone, 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
1 site in 1 country.
About this study
Official title: A Single-Center, Open-Label Pilot Study of a Novel Microlens Array Device for Skin Rejuvenation
A single-center prospective, open-label uncontrolled pilot study. Subjects will receive laser treatments and will be followed at 12 weeks post-final treatment.
- Being tested
- Microlens Array
- Medical subject headings
- Cicatrix
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Microlens ArrayDevice
Treatment with Cutera Microlens Array Device used with the enlighten™ 532nm /1064nm/670nm laser
| Study group | Role | What they receive |
|---|---|---|
| Treatment with Microlens Array | Experimental | Treatment with Cutera Microlens Array Device used with the enlighten™ 532nm /1064nm/670nm laser Receives: Device: Microlens Array |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physician's Global Assessment of Improvement
Degree of improvement at 12 weeks post-final treatment as assessed by the Investigator.
Higher scores indicate better outcomes 3= Very significant Improvement 2= Significant Improvement
1= Moderate Improvement 0= Mild or No Improvement
Measured: 12 weeks post final treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2016 (estimated)
- Study startAug 2016
- Primary completion6 Feb 2017
- Study completion6 Feb 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 WrinklesStudies 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
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cutera Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Stephen Ronan, MD, Principal investigator, P.I.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02888626
- Sponsor's protocol ID
- C-16-ML01
- Status last verified
- Jul 2023
- First submitted
- 23 Aug 2016
- Last updated
- 15 Aug 2023
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Center, Open-Label Pilot Study of a Novel Microlens Array Device for Skin Rejuvenation
- ClinicalTrials.gov ID
- NCT02888626
- Acronym / sponsor ID
- C-16-ML01
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Cutera Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2016 (actual)
- Primary completion
- 6 Feb 2017 (actual)
- Study completion
- 6 Feb 2017 (actual)
- First posted
- 5 Sep 2016 (estimated)
- Results
- Posted 15 Aug 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A single-center prospective, open-label uncontrolled pilot study. Subjects will receive laser treatments and will be followed at 12 weeks post-final treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment with Microlens Array | Experimental | Device: Microlens ArrayTreatment with Cutera Microlens Array Device used with the enlighten™ 532nm /1064nm/670nm laser |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Female or Male, 20 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 of fine rhytides, pigmentation, erythema or telangiectasia.
- 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.
Key exclusion criteria (22 listed)
- Participation in a clinical trial of another drug, or device administered to the target area, within 6 months prior to enrollment or 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, scars, 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 |
|---|---|---|
| Microlens ArrayTreatment with Cutera Microlens Array Device used with the enlighten™ 532nm /1064nm/670nm laser | Device | Treatment with Microlens Array |
Primary outcome
Physician's Global Assessment of Improvement
Time frame: 12 weeks post final treatment
Degree of improvement at 12 weeks post-final treatment as assessed by the Investigator. Higher scores indicate better outcomes 3= Very significant Improvement 2= Significant Improvement 1= Moderate Improvement 0= Mild or No Improvement
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Stephen Ronan, MD principal investigator
P.I.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Microlens Array in people with Wrinkles and Scars, run by Cutera Inc. at 1 site 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 9 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 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Aug 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?
Physician's Global Assessment of Improvement (time frame: 12 weeks post final treatment). 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 15 Aug 2023.