WrinkleNCT03793348
Study to Evaluate the Safety and Efficacy of the Cytrellis Micro-Coring Device for the Treatment of Moderate to Severe Facial Wrinkles
A study testing MCD in people with Wrinkle, run by Cytrellis Biosystems, Inc. at 6 sites in United States.
Trial summary
Study evaluating the efficacy of a micro coring device for the treatment of moderate to severe check wrinkles Read more about this study
- Who is it for?
- Ages 40 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Wrinkle
- What is being tested?
- MCD
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 6 sitesUnited States
- Study dates
- 12 Nov 2018to 21 Aug 2019
- 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 40 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Males and females 40-70 years of age
- Fitzpatrick Skin Type I to IV as judged by the Investigator
- Cheek areas are at least a score of 3 using the Lemperle Wrinkle Assessment Scale as judged by the Investigator
- Able to provide written informed consent, understand and willing to comply with all study related procedures and follow-up visits.
Who cannot join
- Lesions suspicious for any malignancy or the presence of actinic keratosis, melasma, vitiligo, cutaneous papules/nodules or active inflammatory lesions in the areas to be treated
- History of keloid formation or hypertrophic scarring
- History of trauma or surgery to the treatment areas in the past 6 months
- Scar present in the areas to be treated
- Silicone injections in the areas to be treated
- Injection of dermal fillers, fat or botulinum toxin, as well as any minimally invasive/invasive medical device for skin treatment, in the study treatment areas, within the past 6 months (i.e., dermabrasion, laser, RF devices)
Show all 15Show fewer
- Active smokers (0.5 pack/day) or having quit within 3 months prior to treatment
- Active, chronic, or recurrent infection
- History of compromised immune system or currently being treated with immunosuppressive agents
- History of sensitivity to analgesic agents, Aquaphor®, topical or local anesthetics (e.g., lidocaine, benzocaine, procaine) or chlorhexidine, povidone-iodine or epinephrine
- Excessive sun exposure and use of tanning beds or tanning creams within 30 days prior to treatment
- Treatment with aspirin or other blood thinning agents within 14 days prior to treatment
- History or presence of any clinically significant bleeding disorder
- Any issue that, at the discretion of the Investigator, would interfere with assessment of safety or efficacy or compromise the subject's ability to participate in the study
- Treatment with an investigational device or agent within 30 days before treatment or during the study period
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
United States6 sites, 3 recruiting
- Not yet recruiting
Dallas Plastic Surgery Institute
Dallas, Texas, 75231
Casey Martin, 214-823-1978, Casey.Martin@dpsi.org
Jay Burns
- Not yet recruiting
AboutSkin Research, LLC
Greenwood Village, Colorado, 80111
Audrey Langhorst, 303-756-7546, research@aboutskinderm.com
- Active, not recruiting
Miami Dermatology & Laser Institute
Miami, Florida, 33173
- Active, not recruiting
The Office of Brian Biesman, M.D.
Nashville, Tennessee, 37203
- Recruiting
Laser and Skin Surgery of New York
New York, New York, 10016
Jennifer Moreno, 212-686-7306, research@laserskinsurgery.com
Roy Geronemus
- Active, not recruiting
Laser and Skin Surgery Center of Northern California
Sacramento, California, 95816
About this study
Official title: A Prospective, Multi-center, Pivotal Study to Evaluate the Safety and Efficacy of the Cytrellis Micro-Coring Device for the Treatment of Moderate to Severe Facial Wrinkles
Study evaluating the efficacy of a micro coring device for the treatment of moderate to severe check wrinkles
Read the detailed description
Up to 35 subjects who meet the inclusion/exclusion criteria will be treated. All subjects will be monitored for a period of 90 days post treatment.
Study results will be assessed with the following:
- Lemperle Scale
- Investigator GAIS Scale
- Subject Satisfaction Scale
- Conditions
- Wrinkle
- Being tested
- MCD
- Keywords
- facial wrinkles, skin laxity, sagging skin
- Medical subject headings
- Cutis Laxa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MCDDevice
Micro coring skin removal with automated coring device
| Study group | Role | What they receive |
|---|---|---|
| Micro-exisional skin removal | Experimental | Micro-coring of skin on the facial and neck areas will be conducted in one treatment and followed for 90 days post treatment. Receives: Device: MCD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess level of wrinkle improvement using the Lemperle Wrinkle Severity Scale
A mean change of 1 point or greater reduction in cheek wrinkle severity at 90 days post treatment using the Lemperle Wrinkle Severity Scale, as assessed by (3) blinded Independent Reviewers Lemperle Scale:
No wrinkles =0 Just perceptible wrinkles =1 Shallow wrinkles=2 Moderately deep wrinkles=3 Deep wrinkles, well-defined edges =4 Very deep wrinkles, redundant fold=5
Measured: 90 day post treatment
Secondary outcomes (6)
Assess aesthetic improvement using Global Aesthetic Improvement Scale
Overall aesthetic improvement level per Principal Investigator at 90 days compared to baseline on the Global Aesthetic Improvement Scale.
Very Much Improved (Optimal cosmetic result)=3 Much Improved (Marked improvement from the initial condition, but not completely optimal)=2 No Change (The appearance is essentially the same as baseline)=0 Worse (The appearance is worse than the original condition)= -1 Much Worse (Marked worsening in appearance from the initial condition)= - 2 Very Much Worse (Obvious worsening in appearance from the initial condition)=- 3
Measured: 90 day post treatment
Assess aesthetic improvement using Subject Satisfaction Scale
Satisfaction with the aesthetic appearance of the treatment area per Subject Satisfaction Scale compared to baseline.
Extremely dissatisfied=0 Somewhat dissatisfied=1 Slightly dissatisfied=2 Neither satisfied or dissatisfied=3 Slightly satisfied=4 Somewhat satisfied=5 Extremely satisfied=6
Measured: 90 day post treatment
Assess aesthetic improvement in wrinkles using OCT images (optional)
Assessment of improvement using OCT images with Vista software to determine wrinkle depth reduction, comparing pre-treatment depth to post treatment depth.
Measured: Baseline to Day 90 post treatment
Assess efficacy results using Canfield Software,, by comparing the changes in wrinkles at baseline and 90 days post treatment.
Validated Canfield software comparing baseline wrinkles to day 90 follow up wrinkles via automated photo analysis.
Measured: Baseline to Day 90 post treatment
Assess safety profile by recording of adverse events
The incidence and severity of systemic and local adverse events will be recorded by the PI at all visits and a 14 day diary completed by each subject will also be collected.
Measured: Adverse events will be recorded immediately treatment, Day 1, Day 7, Day 30, Day 60 and Day 90 post treatment. Ad hoc assessment can occur upon subject report of AE.
Assess safety profile by reviewing completed 14 day subject diary for potential side effects.
14 day diary completed by each subject will record potential side effects, level of severity (mild = 1; moderate = 2; severe = 3), and end date of the potential side effects.
Measured: For 14 days post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2019
- Study start12 Nov 2018
- Primary completion15 Jun 2019 (estimated)
- Study completion21 Aug 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for WrinkleStudies 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
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cytrellis Biosystems, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03793348
- Sponsor's protocol ID
- AIS 700-00052
- Status last verified
- Jan 2019
- First submitted
- 18 Dec 2018
- Last updated
- 4 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multi-center, Pivotal Study to Evaluate the Safety and Efficacy of the Cytrellis Micro-Coring Device for the Treatment of Moderate to Severe Facial Wrinkles
- ClinicalTrials.gov ID
- NCT03793348
- Acronym / sponsor ID
- AIS 700-00052
- Conditions
- Wrinkle
- Keywords
- facial wrinkles, skin laxity, sagging skin
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Cytrellis Biosystems, Inc.Industry (pharma, biotech, devices)
- Study start
- 12 Nov 2018 (actual)
- Primary completion
- 15 Jun 2019 (estimated)
- Study completion
- 21 Aug 2019 (estimated)
- First posted
- 4 Jan 2019 (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.
Study evaluating the efficacy of a micro coring device for the treatment of moderate to severe check wrinkles
Detailed description
Up to 35 subjects who meet the inclusion/exclusion criteria will be treated. All subjects will be monitored for a period of 90 days post treatment.
Study results will be assessed with the following:
- Lemperle Scale
- Investigator GAIS Scale
- Subject Satisfaction Scale
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Micro-exisional skin removal | Experimental | Device: MCDMicro-coring of skin on the facial and neck areas will be conducted in one treatment and followed for 90 days post treatment. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Males and females 40-70 years of age
- Fitzpatrick Skin Type I to IV as judged by the Investigator
- Cheek areas are at least a score of 3 using the Lemperle Wrinkle Assessment Scale as judged by the Investigator
- Able to provide written informed consent, understand and willing to comply with all study related procedures and follow-up visits.
Key exclusion criteria (15 listed)
- Lesions suspicious for any malignancy or the presence of actinic keratosis, melasma, vitiligo, cutaneous papules/nodules or active inflammatory lesions in the areas to be treated
- History of keloid formation or hypertrophic scarring
- History of trauma or surgery to the treatment areas in the past 6 months
- Scar present in the areas to be treated
- Silicone injections in the areas to be treated
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 |
|---|---|---|
| MCDMicro coring skin removal with automated coring device | Device | Micro-exisional skin removal |
Primary outcome
Assess level of wrinkle improvement using the Lemperle Wrinkle Severity Scale
Time frame: 90 day post treatment
A mean change of 1 point or greater reduction in cheek wrinkle severity at 90 days post treatment using the Lemperle Wrinkle Severity Scale, as assessed by (3) blinded Independent Reviewers Lemperle Scale: No wrinkles =0 Just perceptible wrinkles =1 Shallow wrinkles=2 Moderately deep wrinkles=3 Deep wrinkles, well-defined edges =4 Very deep wrinkles, redundant fold=5
6 secondary outcomes
Assess aesthetic improvement using Global Aesthetic Improvement Scale
Time frame: 90 day post treatment
Assess aesthetic improvement using Subject Satisfaction Scale
Time frame: 90 day post treatment
Assess aesthetic improvement in wrinkles using OCT images (optional)
Time frame: Baseline to Day 90 post treatment
Assess efficacy results using Canfield Software,, by comparing the changes in wrinkles at baseline and 90 days post treatment.
Time frame: Baseline to Day 90 post treatment
Assess safety profile by recording of adverse events
Time frame: Adverse events will be recorded immediately treatment, Day 1, Day 7, Day 30, Day 60 and Day 90 post treatment. Ad hoc assessment can occur upon subject report of AE.
Assess safety profile by reviewing completed 14 day subject diary for potential side effects.
Time frame: For 14 days post treatment
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 4 Jan 2019.
Related trials for Wrinkle
Active, not recruiting
A Prospective Controlled Study to Evaluate the Safety and Effectiveness of Thermage® FLX Radiofrequency Treatment
Wrinkle, Lax Skin
Not yet recruitingPhase 2
Can TrenibotulinumtoxinE Reverse OnabotulinumtoxinA Effect in Treating Lateral Canthal Lines?
Wrinkles and Rhytides
Active, not recruiting
Clinical Study to Evaluate the Safety and Efficacy of Candela Technology
Hair Reduction, Tattoo Removal
Active, not recruiting
Clinical Feasibility Study to Evaluate the Safety and Performance of the Profound Matrix System
Skin Laxity, Wrinkle
Not yet recruiting
A Study to Evaluate the Safety and Effectiveness of GP0112 for Cheek Augmentation and Correction of Midface Contour Deficiencies
Cheek Wrinkles, Midface Contour Deficiencies
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.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MCD in people with Wrinkle, run by Cytrellis Biosystems, Inc. at 6 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 4 inclusion and 15 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: looking for participants now, as of the sponsor's last update on 4 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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?
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assess level of wrinkle improvement using the Lemperle Wrinkle Severity Scale (time frame: 90 day post 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 4 Jan 2019.