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CompletedNCT05270512Updated Nov 22, 2024

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

An interventional study of Dermal Cooling System in Skin Lesion, sponsored by R2 Dermatology. Completed at 4 sites in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-11-22.

Sponsored by R2 Dermatology · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
88
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed description

This is a prospective, non-randomized, open-label study to evaluate the effectiveness of the Dermal Cooling system to determine if cosmetic benefits or physical symptoms are achieved in common skin conditions.

02

Conditions studied

  • Skin Lesion

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03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  1. Male or female subjects > 18 years of age.
  2. Subject has a skin condition amenable to cryosurgical treatment including, for example, psoriasis, atopic dermatitis, acne, rosacea, and melasma.
  3. Subject is willing to have skin exposed to cooling with the Dermal Cooling System.
  4. Subject is willing to have digital photographs taken of the treatment area and agrees to use of photographs for presentation, educational, or marketing purposes.
  5. 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.
  6. Subject has read and signed a written informed consent form.
  7. Subject is willing to comply with adjuvant topical regimen, as applicable.
  8. Subject agrees not to undergo any other procedure(s) in the treatment area during the study.

Exclusion criteria

Exclusion Criteria:

  1. 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
  2. Use of Accutane within the previous 6 months
  3. History of melanoma
  4. Subject is pregnant or intending to become pregnant during the study period
  5. Subject is lactating or has been lactating in the past 6 months
  6. Known history of illness or adverse reaction to cold insult (e.g., cryoglobulinemia, cold urticaria, paroxysmal cold hemoglobinuria, Reynaud's disease.
  7. History of abnormal wound healing or abnormal scarring
  8. Inability or unwillingness to comply with the study requirements.
  9. Current enrollment in a clinical study of any other unapproved investigational drug or device.
  10. 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.
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
88 participants (actual)

Study arms

  • Experimental
    Treatment with Dermal Cooling System

    Dermal Cooling System will be used in all eligible subjects.

    Device: Dermal Cooling System

Interventions

  • DeviceDermal Cooling System

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

05

What researchers measure

Primary outcomes

  1. 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).

    Time frame: up to 3 months

  2. Incidence of treatment-emergent adverse events

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

    Time frame: Up to 12 months

06

Study locations

4 sites
  • West Coast Research
    Dublin, California 94568, United States
  • Oak Dermatology
    Naperville, Illinois 60563, United States
  • Skin Search of Rochester, Inc.
    Rochester, New York 14623, United States
  • Dermatology, Laser and Vein Specialists of the Carolinas
    Charlotte, North Carolina 28207, United States
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT05270512
Lead sponsor
R2 Dermatology
Responsible party
Sponsor
First posted
Mar 8, 2022
Start date
Dec 10, 2021
Primary completion
Nov 1, 2023
Completion
Nov 1, 2023
Last update
Nov 22, 2024

Study contacts

Kristine Tatsutani, PhD
study director · R2 Technologies

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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