Skin LesionNCT05270512
Evaluation of the Dermal Cooling System for Treatment of Common Skin Conditions
A study testing Dermal Cooling System in people with Skin Lesion, run by R2 Dermatology at 4 sites in United States.
Trial summary
The purpose of this study is to evaluate whether the Dermal Cooling System can be used to elicit an improvement in the cosmetic appearance or physical symptoms 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
- 88 participants
- Where
- 4 sitesUnited States
- Study dates
- 10 Dec 2021to 1 Nov 2023
- 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 a skin condition amenable to cryosurgical treatment including, for example, psoriasis, atopic dermatitis, acne, rosacea, and melasma.
- Subject is willing to have skin exposed to cooling with the Dermal Cooling System.
- Subject is willing to have digital photographs taken of the treatment area and agrees to use of photographs for presentation, educational, or marketing purposes.
- Subject is willing to cover treated area or have very limited sun exposure and use an approved sunscreen of SPF 50 or higher on the treated area for the duration of the study, including the follow-up period, if requested.
- Subject has read and signed a written informed consent form.
- Subject is willing to comply with adjuvant topical regimen, as applicable.
- Subject agrees not to undergo any other procedure(s) in the treatment area during the study.
Who cannot join
- 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
- Use of Accutane within the previous 6 months
- History of melanoma
- Subject is pregnant or intending to become pregnant during the study period
- Subject is lactating or has been lactating in the past 6 months
- Known history of illness or adverse reaction to cold insult (e.g., cryoglobulinemia, cold urticaria, paroxysmal cold hemoglobinuria, Reynaud's disease.
Show all 10Show fewer
- History of abnormal wound healing or abnormal scarring
- Inability or unwillingness to comply with the study requirements.
- 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 unacceptable risk to the subject.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Dermatology, Laser and Vein Specialists of the Carolinas
Charlotte, North Carolina, 28207
West Coast Research
Dublin, California, 94568
Oak Dermatology
Naperville, Illinois, 60563
Skin Search of Rochester, Inc.
Rochester, New York, 14623
About this study
The purpose of this study is to evaluate whether the Dermal Cooling System can be used to elicit an improvement in the cosmetic appearance or physical symptoms of common skin conditions.
Read the detailed description
This is a prospective, non-randomized, open-label study to evaluate the effectiveness of the Dermal Cooling system to determine if cosmetic benefits or physical symptoms are achieved in common skin conditions.
- 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
Controlled localized cooling may be applied to lesions using the Dermal Cooling System.
| Study group | Role | What they receive |
|---|---|---|
| Treatment with Dermal Cooling System | Experimental | Dermal Cooling System will be used in all eligible subjects. Receives: Device: Dermal Cooling System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in appearance in the treated area as determined by the Physician Global Assessment (PGA).
Investigator assessment using Physician Global Assessment (PGA); graded from "4" (very much improved") to "0" (worse).
Measured: up to 3 months
Incidence of treatment-emergent adverse events
The safety of the treatment is determined by the incidence of device- or procedure-related serious adverse events.
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2022
- Study start10 Dec 2021
- Primary completion1 Nov 2023
- Study completion1 Nov 2023
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
- 88 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 Technologies
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05270512
- Sponsor's protocol ID
- R2-21-001
- Status last verified
- Nov 2024
- First submitted
- 25 Feb 2022
- Last updated
- 22 Nov 2024
- 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 22 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Dermal Cooling System for Treatment of Common Skin Conditions
- ClinicalTrials.gov ID
- NCT05270512
- Acronym / sponsor ID
- R2-21-001
- Conditions
- Skin Lesion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- R2 DermatologyIndustry (pharma, biotech, devices)
- Study start
- 10 Dec 2021 (actual)
- Primary completion
- 1 Nov 2023 (actual)
- Study completion
- 1 Nov 2023 (actual)
- First posted
- 8 Mar 2022 (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.
The purpose of this study is to evaluate whether the Dermal Cooling System can be used to elicit an improvement in the cosmetic appearance or physical symptoms of common skin conditions.
Detailed description
This is a prospective, non-randomized, open-label study to evaluate the effectiveness of the Dermal Cooling system to determine if cosmetic benefits or physical symptoms are achieved in common skin conditions.
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 Dermal Cooling System | Experimental | Device: Dermal Cooling SystemDermal Cooling System will be used in all eligible subjects. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male or female subjects > 18 years of age.
- Subject has a skin condition amenable to cryosurgical treatment including, for example, psoriasis, atopic dermatitis, acne, rosacea, and melasma.
- Subject is willing to have skin exposed to cooling with the Dermal Cooling System.
- Subject is willing to have digital photographs taken of the treatment area and agrees to use of photographs for presentation, educational, or marketing purposes.
- Subject is willing to cover treated area or have very limited sun exposure and use an approved sunscreen of SPF 50 or higher on the treated area for the duration of the study, including the follow-up period, if requested.
Key exclusion criteria (10 listed)
- 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
- Use of Accutane within the previous 6 months
- History of melanoma
- Subject is pregnant or intending to become pregnant during the study period
- Subject is lactating or has been lactating in the past 6 months
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 SystemControlled localized cooling may be applied to lesions using the Dermal Cooling System. | Device | Treatment with Dermal Cooling System |
Primary outcome
Change in appearance in the treated area as determined by the Physician Global Assessment (PGA).
Time frame: up to 3 months
Investigator assessment using Physician Global Assessment (PGA); graded from "4" (very much improved") to "0" (worse).
Incidence of treatment-emergent adverse events
Time frame: Up to 12 months
The safety of the treatment is determined by the incidence of device- or procedure-related serious adverse events.
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 22 Nov 2024.
- 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 Technologies
4 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 4 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 8 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 22 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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?
Change in appearance in the treated area as determined by the Physician Global Assessment (PGA). (time frame: up to 3 months). The study lists 2 primary outcomes in all. 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 22 Nov 2024.