Skin LaxityNCT02763306
Dermal Cryotherapy in Patients Undergoing Abdominoplasty
A study testing Dermal Cooling System in people with Skin Laxity, run by R2 Dermatology at 2 sites in United States.
Trial summary
A prospective, interventional, single-arm study to evaluate histologic changes in skin following cryotherapy with the study device. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Skin Laxity
- What is being tested?
- Dermal Cooling System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 2 sitesUnited States
- Study dates
- Jun 2015to Apr 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female subjects > 18 years of age.
- Subjects eligible, consented, and scheduled for abdominoplasty.
- Subject is willing to use photoprotection (e.g., sun avoidance) of the treated areas during the duration of the follow-up period.
- Subject has read and signed a written informed consent form. -
Who cannot join
- Subject has medical or surgical treatment in the area of intended treatment in the previous 6 months (e.g., liposuction, mesotherapy, hydroquinone, corticosteroids, laser surgery).
- Subject has a known history of subcutaneous injections into the abdomen within the past six months (e.g., insulin, Enbrel).
- Subject has a known history of illness or adverse reaction to cold insult (e.g., cryoglobulinemia, cold urticaria, paroxysmal cold hemoglobinuria, Reynaud's disease).
- Subject is taking methylxanthines (phosphodiesterase-inhibitors like amino- or theophylline)
- Artificial tanning in the area of intended treatment within 1 month (e.g., spray, lotion, tanning bed) or intention to use artificial tanning within the follow-up period.
- Subject is unable or unwilling to comply with the study requirements.
Show all 12Show fewer
- Subject has any dermatological conditions or scars (other than stretch marks) within the area of planned abdominoplasty excision that may interfere with the ability to obtain test sites for treatment or evaluation.
- Subject has a history of abnormal wound healing or abnormal scarring.
- Subject is currently enrolled in a clinical study of any other unapproved investigational drug or device.
- Patient is pregnant or intending to become pregnant within the next 6 months.
- Patient is lactating or has been lactating in the past 9 months.
- Any other condition or laboratory value that would, in the professional opinion of the investigator, potentially affect response or participation in this clinical study, or would pose an unacceptable risk to the patient.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Kaufman Plastic Surgery
Folsom, California, 95638
Fremont Plastic Surgery
Fremont, California, 94538
About this study
A prospective, interventional, single-arm study to evaluate histologic changes in skin following cryotherapy with the study device.
Read the detailed description
This study is to include healthy adults who intend to undergo an abdominoplasty surgery, and agree to have small areas of their middle and lower abdomen exposed to cooling with the Dermal Cooling System within 180 days before the planned surgery. Exposure of multiple test sites will be completed in areas of skin that will be excised as part of the abdominoplasty procedure. Clinical assessments of the treatment sites at 1-week post-treatment and at 1-month post-treatment intervals throughout the time period prior to surgical excision, and histologic evaluation of the treated skin will be conducted to assess skin changes.
- Conditions
- Skin Laxity
- Being tested
- Dermal Cooling System
- Medical subject headings
- Cutis Laxa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dermal Cooling SystemDevice
Treatment with dermal cooling system.
| Study group | Role | What they receive |
|---|---|---|
| Treatment with cryotherapy | Experimental | Treatment with dermal cooling system. Receives: Device: Dermal Cooling System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Histologic evaluation of treated skin
Identify a range of treatment parameters which elicits a response in melanocytes based upon histologic assessments.
Measured: 1-180 days
Secondary outcomes (1)
Access device or procedure-related adverse events
Assess adverse events and side effects.
Measured: 1 - 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2016 (estimated)
- Study startJun 2015
- Primary completionApr 2017
- Study completionApr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin LaxityStudies 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
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- R2 Dermatology
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David Kaufman, MD, Principal investigator, Kaufman Plastic Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02763306
- Sponsor's protocol ID
- R2-15-002
- Status last verified
- Mar 2021
- First submitted
- 15 Apr 2016
- Last updated
- 29 Mar 2021
- 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 29 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dermal Cryotherapy in Patients Undergoing Abdominoplasty
- ClinicalTrials.gov ID
- NCT02763306
- Acronym / sponsor ID
- R2-15-002
- Conditions
- Skin Laxity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- R2 DermatologyIndustry (pharma, biotech, devices)
- Study start
- Jun 2015 (actual)
- Primary completion
- Apr 2017 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 5 May 2016 (estimated)
- 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.
A prospective, interventional, single-arm study to evaluate histologic changes in skin following cryotherapy with the study device.
Detailed description
This study is to include healthy adults who intend to undergo an abdominoplasty surgery, and agree to have small areas of their middle and lower abdomen exposed to cooling with the Dermal Cooling System within 180 days before the planned surgery. Exposure of multiple test sites will be completed in areas of skin that will be excised as part of the abdominoplasty procedure. Clinical assessments of the treatment sites at 1-week post-treatment and at 1-month post-treatment intervals throughout the time period prior to surgical excision, and histologic evaluation of the treated skin will be conducted to assess skin changes.
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 cryotherapy | Experimental | Device: Dermal Cooling SystemTreatment with dermal cooling system. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female subjects > 18 years of age.
- Subjects eligible, consented, and scheduled for abdominoplasty.
- Subject is willing to use photoprotection (e.g., sun avoidance) of the treated areas during the duration of the follow-up period.
- Subject has read and signed a written informed consent form. -
Key exclusion criteria (12 listed)
- Subject has medical or surgical treatment in the area of intended treatment in the previous 6 months (e.g., liposuction, mesotherapy, hydroquinone, corticosteroids, laser surgery).
- Subject has a known history of subcutaneous injections into the abdomen within the past six months (e.g., insulin, Enbrel).
- Subject has a known history of illness or adverse reaction to cold insult (e.g., cryoglobulinemia, cold urticaria, paroxysmal cold hemoglobinuria, Reynaud's disease).
- Subject is taking methylxanthines (phosphodiesterase-inhibitors like amino- or theophylline)
- Artificial tanning in the area of intended treatment within 1 month (e.g., spray, lotion, tanning bed) or intention to use artificial tanning within the follow-up period.
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 |
|---|---|---|
| Dermal Cooling SystemTreatment with dermal cooling system. | Device | Treatment with cryotherapy |
Primary outcome
Histologic evaluation of treated skin
Time frame: 1-180 days
Identify a range of treatment parameters which elicits a response in melanocytes based upon histologic assessments.
1 secondary outcome
Access device or procedure-related adverse events
Time frame: 1 - 180 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2021.
- 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.
David Kaufman, MD principal investigator
Kaufman Plastic Surgery
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dermal Cooling System in people with Skin Laxity, run by R2 Dermatology 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 4 inclusion and 12 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 29 Mar 2021. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Histologic evaluation of treated skin (time frame: 1-180 days). 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 29 Mar 2021.