Skin LesionNCT03282994
Dermal Cooling System for Cryotherapy of Common Skin Conditions
A study testing Dermal Cooling System in people with Skin Lesion, run by R2 Dermatology at 3 sites in United States.
Trial summary
Prospective, non-randomized, open-label study to evaluate the dermal cooling system for cryotherapy of common skin conditions. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Skin Lesion
- 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
- 34 participants
- Where
- 3 sitesUnited States
- Study dates
- 19 Jul 2017to 17 Nov 2018
- 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.
- Subject has benign superficial lesion(s) associated with common skin conditions amenable to cryosurgical treatment including, for example, psoriasis, acne, rosacea, and sebaceous hyperplasia.
- Subject is willing to have up to 40 test sites treated.
- Subject has read and signed a written informed consent form.
Who cannot join
- Physician prescribed procedures in the area of intended treatment in the previous 6 months (e.g., photodynamic therapy, intense pulsed light therapy, laser surgery).
- Dermatological conditions (e.g. vitiligo, open wounds, infection, pre-cancerous or malignant lesions) in the location of the treatment sites that would, in the professional opinion of the investigator, potentially pose an increased risk to the subject.
- History of melanoma.
- Known history of illness or adverse reaction to cold insult (e.g., cryoglobulinemia, cold urticaria, paroxysmal cold hemoglobinuria, Reynaud's disease).
- History of abnormal wound healing or abnormal scarring
- Inability or unwillingness to comply with the study requirements.
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- Subject is pregnant or planning to become pregnant while enrolled in the study.
- Subject is lactating.
- Current enrollment in a clinical study of any other unapproved investigational drug or device.
- 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 increased or unacceptable risk to the subject.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Dermatology, Laser and Vein Specialists of the Carolinas
Charlotte, North Carolina, 28207
Zel Skin and Laser Specialists
Edina, Minnesota, 55424
Clear Dermatology & Aesthetics Center
Scottsdale, Arizona, 85255
About this study
Official title: Evaluation of the Dermal Cooling System for Cryotherapy of Common Skin Conditions
Prospective, non-randomized, open-label study to evaluate the dermal cooling system for cryotherapy of common skin conditions.
Read the detailed description
The purpose of this study is to establish that controlled localized cooling with the Dermal Cooling System will elicit an improvement in the cosmetic appearance of benign superficial lesions associated with common skin conditions that are currently being treated with cryosurgical methods.
- Conditions
- Skin Lesion
- Being tested
- Dermal Cooling System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dermal Cooling SystemDevice
Cryotherapy
| Study group | Role | What they receive |
|---|---|---|
| Treatment with cryotherapy | Experimental | 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.
Improvement in appearance in the treatment area
Improvement in appearance in the treated area at the 3-month follow-up visit, as determined by the Physician Global Assessment (PGA).
Measured: 3-months
Secondary outcomes (1)
Incidence of procedure related adverse events
- Safety of the treatment as determined by the incidence of device- or procedure-related serious adverse events
Measured: less than 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2017
- Study start19 Jul 2017
- Primary completion17 Nov 2018
- Study completion17 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin LesionStudies 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
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- R2 Dermatology
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kristine Tatsutani, PhD, Study director, R2 Dermatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03282994
- Sponsor's protocol ID
- R2-17-003
- Status last verified
- Aug 2023
- First submitted
- 12 Sep 2017
- Last updated
- 30 Aug 2023
- 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 30 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Dermal Cooling System for Cryotherapy of Common Skin Conditions
- ClinicalTrials.gov ID
- NCT03282994
- Acronym / sponsor ID
- R2-17-003
- Conditions
- Skin Lesion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- R2 DermatologyIndustry (pharma, biotech, devices)
- Study start
- 19 Jul 2017 (actual)
- Primary completion
- 17 Nov 2018 (actual)
- Study completion
- 17 Nov 2018 (actual)
- First posted
- 14 Sep 2017 (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.
Prospective, non-randomized, open-label study to evaluate the dermal cooling system for cryotherapy of common skin conditions.
Detailed description
The purpose of this study is to establish that controlled localized cooling with the Dermal Cooling System will elicit an improvement in the cosmetic appearance of benign superficial lesions associated with common skin conditions that are currently being treated with cryosurgical methods.
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 SystemDermal 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.
- Subject has benign superficial lesion(s) associated with common skin conditions amenable to cryosurgical treatment including, for example, psoriasis, acne, rosacea, and sebaceous hyperplasia.
- Subject is willing to have up to 40 test sites treated.
- Subject has read and signed a written informed consent form.
Key exclusion criteria (10 listed)
- Physician prescribed procedures in the area of intended treatment in the previous 6 months (e.g., photodynamic therapy, intense pulsed light therapy, laser surgery).
- Dermatological conditions (e.g. vitiligo, open wounds, infection, pre-cancerous or malignant lesions) in the location of the treatment sites that would, in the professional opinion of the investigator, potentially pose an increased risk to the subject.
- History of melanoma.
- Known history of illness or adverse reaction to cold insult (e.g., cryoglobulinemia, cold urticaria, paroxysmal cold hemoglobinuria, Reynaud's disease).
- History of abnormal wound healing or abnormal scarring
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 SystemCryotherapy | Device | Treatment with cryotherapy |
Primary outcome
Improvement in appearance in the treatment area
Time frame: 3-months
Improvement in appearance in the treated area at the 3-month follow-up visit, as determined by the Physician Global Assessment (PGA).
1 secondary outcome
Incidence of procedure related adverse events
Time frame: less than 12 months
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 30 Aug 2023.
- 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.
Kristine Tatsutani, PhD study director
R2 Dermatology
3 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 Lesion, run by R2 Dermatology at 3 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 10 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 30 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 3 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?
Improvement in appearance in the treatment area (time frame: 3-months). 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 30 Aug 2023.