PigmentationNCT04493021
Evaluation of the Dermal Cooling System for the Enhanced Treatment of Benign Pigmented Lesions and Common Skin Conditions
A study testing Dermal Cooling System in people with Pigmentation, run by R2 Dermatology at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the Dermal Cooling System for lightening of benign pigmented lesions and to assess additional cosmetic benefits. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pigmentation
- 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
- 137 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Jul 2020to 31 May 2022
- 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, freckles, seborrheic keratosis), in an area suitable for treatment.
- Subject is willing to have up to 40 treatment sites treated per treatment session 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 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. -
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)
- Use of products containing glycolic acids, retinol, salicylic acid within the previous 2 weeks
- Use of Accutane within the previous 6 months
- 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 melasma, vitiligo, eczema, or psoriasis in the area of treatment
Show all 15Show fewer
- 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.
- 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
1 site in 1 country.
About this study
The purpose of this study is to evaluate the Dermal Cooling System for lightening of benign pigmented lesions and to assess additional cosmetic benefits.
Read the detailed description
This is a prospective, non-randomized, open-label study to evaluate the effectiveness of the Dermal Cooling system to reduce pigmentation in benign pigmented lesions and to determine if additional cosmetic benefits are achieved.
- Conditions
- Pigmentation
- 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 will be applied to benign pigmented 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.
Improvement in the appearance of the treated areas as assessed by Investigator assessment.
Investigator assessment using Global Aesthetic Improvement Scale (GAIS); graded from "4" (very much improved") to "0" (worse).
Measured: 2-Month Follow-up visit
Safety of the treatment
Determined by incidence of device-or procedure-related 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 posted30 Jul 2020
- Study start7 Jul 2020
- Primary completion31 May 2022
- Study completion31 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PigmentationStudies 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
- 137 participants (actual)
Sponsor and investigators
- Lead sponsor
- R2 Dermatology
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Andre Bonnett, MD, Principal investigator, Sculptology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04493021
- Sponsor's protocol ID
- R2-20-001
- Status last verified
- Aug 2023
- First submitted
- 26 Jul 2020
- Last updated
- 30 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
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 the Enhanced Treatment of Benign Pigmented Lesions and Common Skin Conditions
- ClinicalTrials.gov ID
- NCT04493021
- Acronym / sponsor ID
- R2-20-001
- Conditions
- Pigmentation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 137 participants (actual)
- Lead sponsor
- R2 DermatologyIndustry (pharma, biotech, devices)
- Study start
- 7 Jul 2020 (actual)
- Primary completion
- 31 May 2022 (actual)
- Study completion
- 31 May 2022 (actual)
- First posted
- 30 Jul 2020 (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 the Dermal Cooling System for lightening of benign pigmented lesions and to assess additional cosmetic benefits.
Detailed description
This is a prospective, non-randomized, open-label study to evaluate the effectiveness of the Dermal Cooling system to reduce pigmentation in benign pigmented lesions and to determine if additional cosmetic benefits are achieved.
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 (7 listed)
- Male or female subjects > 18 years of age.
- Subject has one or more benign pigmented lesions (e.g., solar lentigines, freckles, seborrheic keratosis), in an area suitable for treatment.
- Subject is willing to have up to 40 treatment sites treated per treatment session 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 area for the duration of the study, including the follow-up period, if requested.
Key exclusion criteria (15 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)
- Use of products containing glycolic acids, retinol, salicylic acid within the previous 2 weeks
- Use of Accutane within the previous 6 months
- 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
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 will be applied to benign pigmented lesions using the Dermal Cooling System | Device | Treatment with Dermal Cooling System |
Primary outcome
Improvement in the appearance of the treated areas as assessed by Investigator assessment.
Time frame: 2-Month Follow-up visit
Investigator assessment using Global Aesthetic Improvement Scale (GAIS); graded from "4" (very much improved") to "0" (worse).
Safety of the treatment
Time frame: Up to 12 months
Determined by incidence of device-or procedure-related 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 30 Aug 2023.
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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.
Andre Bonnett, MD principal investigator
Sculptology
1 site 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 Pigmentation, run by R2 Dermatology at 1 site 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 7 inclusion and 15 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 1 site 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 the appearance of the treated areas as assessed by Investigator assessment. (time frame: 2-Month Follow-up visit). 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 30 Aug 2023.