Dermal Cooling System for Skin Conditions

No longer recruiting at 3 trial locations

Overseen By Dennell A Vargas

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: R2 Dermatology

Must not be taking: Accutane

Disqualifiers: Melanoma, Pregnancy, Lactation, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 3 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a Dermal Cooling System to determine its effectiveness in improving the appearance or symptoms of common skin conditions such as psoriasis, acne, or rosacea. Participants will use this cooling system on their skin, and digital photos will track any changes. It suits individuals over 18 with a skin condition treatable by freezing and who can avoid sun exposure on the treated area. As an unphased trial, this study provides a unique opportunity to explore a new treatment option for skin conditions.

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 prior data suggests that the Dermal Cooling System is safe for skin conditions?

Studies have shown that the Dermal Cooling System is generally safe and well-tolerated. One study used this system to treat non-cancerous skin growths and found it effective and safe, particularly for individuals with colored skin conditions.

Although specific safety data for other skin conditions is lacking, the system briefly touches the skin, reducing risk. Its approval for procedures like removing non-cancerous growths suggests safety for similar uses.

Overall, despite the absence of specific safety data for every skin condition, its prior use in medical procedures suggests it is likely well-tolerated. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Dermal Cooling System is unique because it offers a non-invasive approach to managing skin conditions by directly cooling the skin. Unlike typical topical creams or oral medications that may take time to penetrate the skin's layers or circulate through the body, this system provides immediate relief by lowering skin temperature, potentially reducing inflammation and discomfort quickly. Researchers are excited about this treatment's potential to offer rapid symptom management without the side effects associated with systemic drugs.

What evidence suggests that the Dermal Cooling System is effective for skin conditions?

Research has shown that the Dermal Cooling System may improve skin conditions. In one study, 76.5% of treated areas showed clear improvement two months after using the system, and 58.6% showed significant improvement. These benefits remained visible six months later. The system cools the skin, which can reduce symptoms and enhance appearance. This treatment is also used in procedures to remove non-cancerous skin growths. Overall, these findings suggest that the Dermal Cooling System could be effective for various skin conditions. ^{1 2 3 5 6}

Who Is on the Research Team?

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

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.

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?

Group I: Treatment with Dermal Cooling System Experimental Treatment 1 Intervention

Dermal Cooling System will be used in all eligible subjects.

Who Is Running the Clinical Trial?

R2 Dermatology

Lead Sponsor

Trials

6

Recruited

840+

Published Research Related to This Trial

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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05270512?term=AREA%5BInterventionSearch%5D(in%20dermal)%20AND%20AREA%5BStudyType%5D(INTERVENTIONAL)&rank=7&checkSpell=

Study Details | Evaluation of the Dermal Cooling System for ... An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during a clinical study or within a certain amount of ...

2. withpower.com withpower.com/trial/phase-cutaneous-lesions-11-2021-28df6

Dermal Cooling System for Skin Conditions · Info for Participants Recent advancements in laser technology have significantly improved the treatment of various skin conditions, including vascular and pigmented lesions, tattoos, ...

3. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1002/lsm.23809

Evaluation of a Novel Dermal Cooling System for the ... At 2-month posttreatment, 76.5% and 58.6% treatment sites showed obvious to marked improvement respectively and the improvement sustained at 6 ...

4. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf17/K171398.pdf

R2 Dermatology, Inc. Mr. Bijesh Chandran Sr. Director, RA/QA ... The Dermal Cooling System is a cryosurgical instrument intended for use in dermatologic procedures for the removal of benign lesions of the skin ...

5. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05270512/evaluation-of-the-dermal-cooling-system-for-treatment-of-common-skin-conditions

Evaluation of the Dermal Cooling System for Treatment ... This is a prospective, non-randomized, open-label study to evaluate the effectiveness of the Dermal Cooling system to determine if cosmetic ...

6. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf16/K161480.pdf

October 5, 2016 R2 Dermatology, Inc. Kristine Tatsutani, Ph.D ... The Dermal Cooling System is considered a skin contacting, surface device for limited duration (< 24 hours). Cytotoxicity, sensitization ...