Dermal Cooling System for Skin Conditions
Recruiting at 3 trial locations
DA
Overseen ByDennell A Vargas
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: R2 Dermatology
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial is testing a device called the Dermal Cooling System, which cools the skin. It aims to see if this can improve how the skin looks and feels for people with common skin conditions. Cooling the skin may help by reducing inflammation and redness.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot have used Accutane in the past 6 months.
Is the Dermal Cooling System generally safe for use in humans?
How does the Dermal Cooling System treatment differ from other treatments for skin conditions?
What data supports the effectiveness of the Dermal Cooling System treatment for skin conditions?
Who Is on the Research Team?
KT
Kristine Tatsutani, PhD
Principal Investigator
R2 Technologies
Are You a Good Fit for This Trial?
Adults over 18 with common skin conditions like psoriasis, dermatitis, acne, rosacea, and melasma can join this trial. They must be willing to avoid sun exposure on the treated area or use SPF 50 sunscreen if needed and not participate in other skin treatments during the study. Pregnant women, recent mothers, those with a history of melanoma or adverse reactions to cold are excluded.Inclusion Criteria
Subject has read and signed a written informed consent form
I have a skin condition like psoriasis or acne that can be treated with freezing.
Subject is willing to have digital photographs taken of the treatment area and agrees to use of photographs for presentation, educational, or marketing purposes
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Exclusion Criteria
Current enrollment in a clinical study of any other unapproved investigational drug or device
Inability or unwillingness to comply with the study requirements
I have had melanoma in the past.
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Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive treatment with the Dermal Cooling System to evaluate cosmetic and physical symptom improvements
3 months
Follow-up
Participants are monitored for safety and effectiveness after treatment
9 months
What Are the Treatments Tested in This Trial?
Interventions
- Dermal Cooling System
Trial Overview The Dermal Cooling System is being tested for its effectiveness in improving the appearance and symptoms of various skin conditions. Participants will have their affected skin cooled by this system to see if there's an improvement.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Treatment with Dermal Cooling SystemExperimental Treatment1 Intervention
Dermal Cooling System will be used in all eligible subjects.
Find a Clinic Near You
Who Is Running the Clinical Trial?
R2 Dermatology
Lead Sponsor
Trials
6
Recruited
840+
Published Research Related to This Trial
Recent advancements in laser technology have significantly improved the treatment of various skin conditions, including vascular and pigmented lesions, tattoos, scars, and unwanted hair, leading to better clinical outcomes.
The increased demand for laser surgery is attributed to its effectiveness and low risk of adverse effects, providing both patients and dermatologists with more treatment options and enhanced safety.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Lasers in dermatology: four decades of progress.Tanzi, EL., Lupton, JR., Alster, TS.[2007]
Current strategies for monitoring adverse events (AEs) in dermatologic surgery are inconsistent, with morbidity and mortality conferences being the most common reporting method, but more sensitive approaches like retrospective medical record reviews and anonymous electronic systems exist.
There is no standard for AE reporting in dermatologic surgery, highlighting the need for pilot studies to establish effective measures that can enhance AE detection and improve patient safety outcomes.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Detecting adverse events in dermatologic surgery.Pinney, D., Pearce, DJ., Feldman, SR.[2019]
Citations
Office practices that may improve the experience of the cosmetic dermatology patient. [2022]
Lasers in dermatology: four decades of progress. [2007]
Clinical uses of lasers in dermatology. [2019]
Patient-Reported Outcome Measurement in Clinical Dermatological Practice: Relevance and Feasibility of a Web-Based Portal. [2016]
A review of non-pharmacologic approaches to enhance the patient experience in dermatologic surgery. [2020]
Detecting adverse events in dermatologic surgery. [2019]
Quantifying and characterizing adverse events in dermatologic surgery. [2013]
Grading dermatologic adverse events of cancer treatments: the Common Terminology Criteria for Adverse Events Version 4.0. [2022]
[Laser therapy in dermatology and esthetic medicine. Side effects, complications and treatment errors]. [2019]
Multicenter prospective cohort study of the incidence of adverse events associated with cosmetic dermatologic procedures: lasers, energy devices, and injectable neurotoxins and fillers. [2016]
Treatment of benign pigmented lesions using a novel Dermal Cooling System. [2020]
Active skin cooling in conjunction with laser dermatologic surgery. [2014]
Evaluation of cooling methods for laser dermatology. [2019]
Cold air in laser therapy: first experiences with a new cooling system. [2008]
[Cooling action of topicals--present results and testing methods in vivo and in vitro]. [2013]
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