Skin LighteningNCT02744794
Evaluation of a New Dermal Cryotherapy System
A study testing Dermal Cooling System in people with Skin Lightening, run by R2 Dermatology at 3 sites in United States.
Trial summary
A pilot study to evaluate the feasibility of altering skin pigmentation using the Dermal Cooling System. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Skin Lightening
- 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
- 175 participants
- Where
- 3 sitesUnited States
- Study dates
- 27 Apr 2015to 12 Jun 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 is willing to have up to 40 test sites treated on aesthetically discreet skin.
- 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
- Fitzpatrick skin type VI.
- Physician prescribed, medical or surgical treatment 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
- Dermatological conditions or scars in the location of the treatment sites
- History of melanoma, personal or first degree relative
- 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 study requirments.
- 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
3 sites in 1 country.
United States3 sites
Bowes Dermatology
Miami, Florida, 33133
Center of Dermatology and Laser Surgery
Sacramento, California, 65819
Diablo Clinical Research
Walnut Creek, California, 94598
About this study
A pilot study to evaluate the feasibility of altering skin pigmentation using the Dermal Cooling System.
Read the detailed description
This non-significant risk study is being performed to test the hypothesis that a new treatment concept, controlled localized cooling of the epidermal layer, can be used to lighten areas of the skin.
- Conditions
- Skin Lightening
- 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
Treatment with cryotherapy.
| 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.
Skin pigmentation changes
Changes in pigmentation graded using a 7-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 posted20 Apr 2016 (estimated)
- Study start27 Apr 2015
- Primary completion20 Mar 2018
- Study completion12 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin LighteningStudies 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
- 175 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
- NCT02744794
- Sponsor's protocol ID
- R2-15-001
- Status last verified
- Sep 2018
- First submitted
- 18 Apr 2016
- Last updated
- 12 Sep 2018
- 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 12 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a New Dermal Cryotherapy System
- ClinicalTrials.gov ID
- NCT02744794
- Acronym / sponsor ID
- R2-15-001
- Conditions
- Skin Lightening
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 175 participants (actual)
- Lead sponsor
- R2 DermatologyIndustry (pharma, biotech, devices)
- Study start
- 27 Apr 2015 (actual)
- Primary completion
- 20 Mar 2018 (actual)
- Study completion
- 12 Jun 2018 (actual)
- First posted
- 20 Apr 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 pilot study to evaluate the feasibility of altering skin pigmentation using the Dermal Cooling System.
Detailed description
This non-significant risk study is being performed to test the hypothesis that a new treatment concept, controlled localized cooling of the epidermal layer, can be used to lighten areas of the skin.
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.
- Subject is willing to have up to 40 test sites treated on aesthetically discreet skin.
- 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 (10 listed)
- Fitzpatrick skin type VI.
- Physician prescribed, medical or surgical treatment 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
- Dermatological conditions or scars in the location of the treatment sites
- History of melanoma, personal or first degree relative
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 cryotherapy. | Device | Treatment with cryotherapy |
Primary outcome
Skin pigmentation changes
Time frame: 90 days
Changes in pigmentation graded using a 7-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 12 Sep 2018.
- Individual participant dataSharing planned: No
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.
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 Lightening, 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 12 Sep 2018. 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?
Skin pigmentation changes (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 12 Sep 2018.