NCT05270512

Brief Summary

The purpose of this study is to evaluate whether the Dermal Cooling System can be used to elicit an improvement in the cosmetic appearance or physical symptoms of common skin conditions.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
88

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2021

Typical duration for not_applicable

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 10, 2021

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 25, 2022

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 8, 2022

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2023

Completed
Last Updated

November 22, 2024

Status Verified

November 1, 2024

Enrollment Period

1.9 years

First QC Date

February 25, 2022

Last Update Submit

November 19, 2024

Conditions

Skin Lesion

Outcome Measures

Primary Outcomes (2)

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

    Investigator assessment using Physician Global Assessment (PGA); graded from "4" (very much improved") to "0" (worse).

    up to 3 months

  • Incidence of treatment-emergent adverse events

    The safety of the treatment is determined by the incidence of device- or procedure-related serious adverse events.

    Up to 12 months

Study Arms (1)

Treatment with Dermal Cooling System

EXPERIMENTAL

Dermal Cooling System will be used in all eligible subjects.

Device: Dermal Cooling System

Interventions

Dermal Cooling SystemDEVICE

Controlled localized cooling may be applied to lesions using the Dermal Cooling System.

Treatment with Dermal Cooling System

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female subjects \> 18 years of age.
  • Subject has a skin condition amenable to cryosurgical treatment including, for example, psoriasis, atopic dermatitis, acne, rosacea, and melasma.
  • Subject is willing to have skin exposed to cooling with the Dermal Cooling System.
  • Subject is willing to have digital photographs taken of the treatment area and agrees to use of photographs for presentation, educational, or marketing purposes.
  • Subject is 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.
  • Subject has read and signed a written informed consent form.
  • Subject is willing to comply with adjuvant topical regimen, as applicable.
  • Subject agrees not to undergo any other procedure(s) in the treatment area during the study.

You may not qualify if:

  • Dermatological conditions (e.g. vitiligo, open wounds, infection, pre-cancerous or malignant lesions) in the location of the treatment sites that would, in the professional opinion of the investigator, potentially pose an increased risk to the subject
  • Use of Accutane within the previous 6 months
  • History of melanoma
  • Subject is pregnant or intending to become pregnant during the study period
  • Subject is lactating or has been lactating in the past 6 months
  • Known history of illness or adverse reaction to cold insult (e.g., cryoglobulinemia, cold urticaria, paroxysmal cold hemoglobinuria, Reynaud's disease.
  • History of abnormal wound healing or abnormal scarring
  • Inability or unwillingness to comply with the study requirements.
  • Current enrollment in a clinical study of any other unapproved investigational drug or device.
  • Any other condition or laboratory value that would, in the professional opinion of the investigator, potentially affect response or participation in this clinical study, or would pose an unacceptable risk to the subject.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

West Coast Research

Dublin, California, 94568, United States

Location

Oak Dermatology

Naperville, Illinois, 60563, United States

Location

Skin Search of Rochester, Inc.

Rochester, New York, 14623, United States

Location

Dermatology, Laser and Vein Specialists of the Carolinas

Charlotte, North Carolina, 28207, United States

Location

Study Officials

  • Kristine Tatsutani, PhD

    R2 Technologies

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 25, 2022

First Posted

March 8, 2022

Study Start

December 10, 2021

Primary Completion

November 1, 2023

Study Completion

November 1, 2023

Last Updated

November 22, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations

US(4)