Dermal Cooling System for Skin Lesions

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Skin LesionsDermal Cooling System - Device
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

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

Eligible Conditions
  • Skin Lesions

Treatment Effectiveness

Effectiveness Progress

1 of 3

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Romidepsin
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SIM1811-03 Monotherapy
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UCT-03-008

Study Objectives

2 Primary · 0 Secondary · Reporting Duration: Up to 12 months

Up to 12 months
Incidence of treatment-emergent adverse events
up to 3 months
Change in appearance in the treated area as determined by the Physician Global Assessment (PGA).

Trial Safety

Safety Progress

1 of 3

Similar Trials

1
Romidepsin
1
SIM1811-03 Monotherapy
1
UCT-03-008

Trial Design

1 Treatment Group

Treatment with Dermal Cooling System
1 of 1

Experimental Treatment

200 Total Participants · 1 Treatment Group

Primary Treatment: Dermal Cooling System · No Placebo Group · N/A

Treatment with Dermal Cooling System
Device
Experimental Group · 1 Intervention: Dermal Cooling System · Intervention Types: Device
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dermal Cooling System
2015
N/A
~580

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 12 months

Who is running the clinical trial?

R2 DermatologyLead Sponsor
5 Previous Clinical Trials
890 Total Patients Enrolled
Kristine Tatsutani, PhDStudy DirectorR2 Technologies
3 Previous Clinical Trials
712 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 8 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are a male or female > 18 years of age.
You are willing to have skin exposed to cooling with the Dermal Cooling System.
You are willing to comply with adjuvant topical regimen, as applicable.
You have a skin condition amenable to cryosurgical treatment.
You are willing to cover treated area or have very limited sun exposure and use an approved sunscreen of SPF 50 or higher on the treated area for the duration of the study, including the follow-up period, if requested.
References

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