What side effects are associated with this type of intervention?

Common treatments for skin lesions that aim to reduce inflammation and redness include cryotherapy, laser therapy, and photodynamic therapy. Cryotherapy can cause side effects such as blistering, pigmentary changes, and, in some cases, infection. Laser therapy may lead to erythema, edema, pigmentary alterations, and blistering. Photodynamic therapy can result in pain, erythema, and edema, with some patients experiencing mild to moderate discomfort during and after treatment. These treatments are generally well-tolerated, but side effects can vary depending on the specific method and patient response.

What prior FDA approvals exist?

The FDA has approved several treatments for skin lesions that focus on reducing inflammation and redness. Notably, two automated scalp cooling devices, the DigniCap and Paxman scalp hypothermia systems, have been cleared by the FDA for preventing chemotherapy-induced alopecia, which involves cooling to reduce inflammation and protect hair follicles. Additionally, nonablative skin resurfacing technologies, such as the 1320 nm Nd:YAG laser and the 1450 nm diode laser, often incorporate cryogen spray cooling to prevent heat-related damage and reduce erythema and edema. These treatments highlight the FDA's recognition of cooling technologies in managing skin conditions.

What other types of research exist?

Promising alternatives to the Dermal Cooling System for reducing inflammation and redness in skin lesions include: 1) Photodynamic Therapy (PDT) with daylight activation, which has shown effectiveness and minimal pain in treating actinic keratosis. 2) Topical treatments with anti-inflammatory properties, such as corticosteroids or non-steroidal anti-inflammatory drugs (NSAIDs). 3) Laser therapies, including pulsed dye laser (PDL) and intense pulsed light (IPL), which target vascular components to reduce redness. 4) Cryotherapy, which uses liquid nitrogen to treat various skin lesions and reduce inflammation. These alternatives offer different mechanisms of action and can be tailored to individual patient needs.

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N/A

Dermal Cooling System for Skin Conditions

N/A

Waitlist Available

Research Sponsored by R2 Dermatology

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Subject has a skin condition amenable to cryosurgical treatment including, for example, psoriasis, atopic dermatitis, acne, rosacea, and melasma

Subject agrees not to undergo any other procedure(s) in the treatment area during the study

Must not have

History of melanoma

History of abnormal wound healing or abnormal scarring

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 12 months

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include discomfort from cooling, temporary redness or irritation at the treatment site. Individuals with certain conditions might experience more serious complications due to sensitivity to cold.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have a skin condition like psoriasis or acne that can be treated with freezing.

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I agree not to have any other treatments in the area being studied while in the trial.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had melanoma in the past.

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I have had issues with wound healing or scarring.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in appearance in the treated area as determined by the Physician Global Assessment (PGA).

Incidence of treatment-emergent adverse events

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment with Dermal Cooling SystemExperimental Treatment1 Intervention

Dermal Cooling System will be used in all eligible subjects.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Dermal Cooling System

2021

N/A

~840

0 / 4Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Cooling treatments, such as the Dermal Cooling System, work by reducing inflammation and redness in skin lesions through the application of cold temperatures. This method constricts blood vessels, decreases metabolic activity, and numbs nerve endings, which helps to alleviate pain and swelling. For patients with skin lesions, this is particularly important as it can provide immediate symptomatic relief and improve the cosmetic appearance of the affected area. Other common treatments for skin lesions include topical therapies like salicylic acid, which helps to exfoliate the skin and remove lesions, and cryotherapy, which uses extreme cold to destroy abnormal tissue. These treatments are essential for managing symptoms, preventing infection, and promoting healing.

Cryotherapy vs trichloroacetic acid 90% in treatment of common warts.Local treatments for cutaneous warts.