88 Participants Needed

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)

Trial Summary

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.

What data supports the effectiveness of the Dermal Cooling System treatment for skin conditions?

The review of non-pharmacologic approaches in dermatologic surgery suggests that cold therapy, similar to the Dermal Cooling System, can improve patient comfort by reducing pain and anxiety, which may enhance clinical outcomes and patient satisfaction.12345

Is the Dermal Cooling System generally safe for use in humans?

There is no specific safety data available for the Dermal Cooling System, but dermatologic procedures are generally considered safe with a low incidence of adverse events, although detailed prospective data is lacking.678910

How does the Dermal Cooling System treatment differ from other treatments for skin conditions?

The Dermal Cooling System is unique because it provides localized and controlled freezing to treat benign pigmented lesions, offering little-to-no downtime compared to other methods like cryotherapy or laser treatments, which can cause more significant side effects and recovery time.1112131415

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.

Research Team

KT

Kristine Tatsutani, PhD

Principal Investigator

R2 Technologies

Eligibility Criteria

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
See 5 more

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.
See 7 more

Timeline

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

Treatment Details

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.
Participant Groups
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+

Findings from Research

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.
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.
Detecting adverse events in dermatologic surgery.Pinney, D., Pearce, DJ., Feldman, SR.[2019]

References

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]
10.United Statespubmed.ncbi.nlm.nih.gov
Multicenter prospective cohort study of the incidence of adverse events associated with cosmetic dermatologic procedures: lasers, energy devices, and injectable neurotoxins and fillers. [2016]
11.United Statespubmed.ncbi.nlm.nih.gov
Treatment of benign pigmented lesions using a novel Dermal Cooling System. [2020]
12.United Statespubmed.ncbi.nlm.nih.gov
Active skin cooling in conjunction with laser dermatologic surgery. [2014]
13.United Statespubmed.ncbi.nlm.nih.gov
Evaluation of cooling methods for laser dermatology. [2019]
14.United Statespubmed.ncbi.nlm.nih.gov
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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