Pigmented Skin LesionNCT02848742
Dermal Cryotherapy for Treatment of Pigmented Lesions
A study testing Dermal Cooling System in people with Pigmented Skin Lesion, run by R2 Dermatology at 2 sites in 2 countries.
Trial summary
Study to evaluate the ability of the Dermal Cooling System to reduce pigmentation in benign pigmented lesions. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pigmented 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
- 377 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Jun 2016to Mar 2020
- 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 one or more benign pigmented lesions (e.g., solar lentigines, melasma, freckles, café au lait, nevi, or hyperpigmentation), in an area suitable for treatment
- Subject is willing to have up to 40 treatment sites and/or an area up to 8 square inches treated depending on the size and nature of the lesions identified.
- 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 areas for the duration of the study, including the follow-up period, if requested.
- Subject has read and signed a written informed consent form.
Who cannot join
- Physician prescribed medical or surgical treatment, or use of over-the-counter products to alter skin color, in the area of intended treatment in the previous 6 months (e.g., hydroquinone, corticosteroids, laser surgery)
- 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
- Scars or tattoos in the location of the treatment sites
- History of vitiligo, eczema, or psoriasis in the area of treatment
- History of melanoma
- Known history of illness or adverse reaction to cold insult (e.g., cryoglobulinemia, cold urticaria, paroxysmal cold hemoglobinuria, Reynaud's disease.
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- 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
2 sites in 2 countries.
2 sites in 2 countries
United States1 site
Diablo Clinical Research
Walnut Creek, California, 94598
About this study
Official title: Evaluation of a New Dermal Cryotherapy System for the Treatment of Benign Pigmented Lesions
Study to evaluate the ability of the Dermal Cooling System to reduce pigmentation in benign pigmented lesions.
Read the detailed description
This study is a prospective, non-randomized, multi-center study of the Dermal Cooling System to verify that the device causes a reduction in pigmentation in benign pigmented lesions, and to determine at what parameters the device is most effective.
- Conditions
- Pigmented 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
Dermal cryotherapy
| Study group | Role | What they receive |
|---|---|---|
| Treatment with cryotherapy device | Experimental | To include subjects with one or more benign pigmented lesions who are willing to have the pigmented skin exposed to cooling with the 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.
Reduction of pigmentation in treated lesions
Changes in pigmentation graded using a 4-point standardized scale
Measured: 90 days
Secondary outcomes (1)
Evaluation of device- or procedure-related adverse events
Side effects, discomfort assessments both during treatment and follow-up
Measured: 0 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 posted28 Jul 2016 (estimated)
- Study startJun 2016
- Primary completionMar 2020
- Study completionMar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pigmented 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
- 377 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, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02848742
- Sponsor's protocol ID
- R2-16-001
- Status last verified
- Mar 2021
- First submitted
- 26 Jul 2016
- Last updated
- 29 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- 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
- Evaluation of a New Dermal Cryotherapy System for the Treatment of Benign Pigmented Lesions
- ClinicalTrials.gov ID
- NCT02848742
- Acronym / sponsor ID
- R2-16-001
- Conditions
- Pigmented Skin Lesion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 377 participants (actual)
- Lead sponsor
- R2 DermatologyIndustry (pharma, biotech, devices)
- Study start
- Jun 2016
- Primary completion
- Mar 2020 (actual)
- Study completion
- Mar 2020 (actual)
- First posted
- 28 Jul 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.
Study to evaluate the ability of the Dermal Cooling System to reduce pigmentation in benign pigmented lesions.
Detailed description
This study is a prospective, non-randomized, multi-center study of the Dermal Cooling System to verify that the device causes a reduction in pigmentation in benign pigmented lesions, and to determine at what parameters the device is most effective.
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 device | Experimental | Device: Dermal Cooling SystemTo include subjects with one or more benign pigmented lesions who are willing to have the pigmented skin exposed to cooling with the Dermal Cooling System. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female subjects > 18 years of age.
- Subject has one or more benign pigmented lesions (e.g., solar lentigines, melasma, freckles, café au lait, nevi, or hyperpigmentation), in an area suitable for treatment
- Subject is willing to have up to 40 treatment sites and/or an area up to 8 square inches treated depending on the size and nature of the lesions identified.
- 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 areas for the duration of the study, including the follow-up period, if requested.
Key exclusion criteria (10 listed)
- Physician prescribed medical or surgical treatment, or use of over-the-counter products to alter skin color, in the area of intended treatment in the previous 6 months (e.g., hydroquinone, corticosteroids, laser surgery)
- 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
- Scars or tattoos in the location of the treatment sites
- History of vitiligo, eczema, or psoriasis in the area of treatment
- History of melanoma
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 SystemDermal cryotherapy | Device | Treatment with cryotherapy device |
Primary outcome
Reduction of pigmentation in treated lesions
Time frame: 90 days
Changes in pigmentation graded using a 4-point standardized scale
1 secondary outcome
Evaluation of device- or procedure-related adverse events
Time frame: 0 to 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 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.
Kristine Tatsutani, PhD study director
R2 Dermatology, Inc.
2 sites in 2 countries: 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 Pigmented Skin Lesion, run by R2 Dermatology at 2 sites in 2 countries.
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 6 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 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, Canada. 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?
Reduction of pigmentation in treated lesions (time frame: 90 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.