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N/A

Dermal Cooling System for Skin Conditions

N/A

Recruiting

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 12 months

Awards & highlights

Study Summary

This trial will test whether a cooling system can improve the appearance or symptoms of common skin conditions.

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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Incidence of treatment-emergent adverse events

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

2015

N/A

~760

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

R2 DermatologyLead Sponsor

5 Previous Clinical Trials

751 Total Patients Enrolled

Kristine Tatsutani, PhDStudy DirectorR2 Technologies

3 Previous Clinical Trials

586 Total Patients Enrolled

Media Library

Dermal Cooling System (N/A) Clinical Trial Eligibility Overview. Trial Name: NCT05270512 — N/A

Skin Lesions Research Study Groups: Treatment with Dermal Cooling System

Skin Lesions Clinical Trial 2023: Dermal Cooling System Highlights & Side Effects. Trial Name: NCT05270512 — N/A

Dermal Cooling System (N/A) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05270512 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the enrollment process for this research project still open?

"Affirmative. Clinicaltrials.gov indicates that this research project, initially publicised on December 10th 2021, is currently enrolling individuals into the study. 200 people are required to be recruited between 4 separate sites."

Answered by AI

What is the participant enrollment count for this experiment?

"Affirmative. Clinicaltrials.gov data demonstrates that this clinical research is presently searching for participants, which were initially posted online on 10th December 2021 and last updated on March 10th 2022. 200 patients are needed from 4 separate test sites."

Answered by AI

What is the geographical extent of this trial's implementation?

"This medical investigation is hosted at four centres, such as Dermatology, Laser and Vein Specialists of the Carolinas in Charlotte; West Coast Research in Dublin; Oak Dermatology in Naperville. Additionally, it is available elsewhere."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Evaluation of the Dermal Cooling System for Treatment of Common Skin Conditions

2021. "Evaluation of the Dermal Cooling System for Treatment of Common Skin Conditions". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05270512.