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CompletedNCT03282994Updated Aug 30, 2023

Dermal Cooling System for Cryotherapy of Common Skin Conditions

An interventional study of Dermal Cooling System in Skin Lesion, sponsored by R2 Dermatology. Completed at 3 sites in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-08-30.

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

Phase
Not applicable
Study type
Interventional
Enrollment
34
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

Prospective, non-randomized, open-label study to evaluate the dermal cooling system for cryotherapy of common skin conditions.

Read the detailed description

The purpose of this study is to establish that controlled localized cooling with the Dermal Cooling System will elicit an improvement in the cosmetic appearance of benign superficial lesions associated with common skin conditions that are currently being treated with cryosurgical methods.

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 benign superficial lesion(s) associated with common skin conditions amenable to cryosurgical treatment including, for example, psoriasis, acne, rosacea, and sebaceous hyperplasia.
  3. Subject is willing to have up to 40 test sites treated.
  4. Subject has read and signed a written informed consent form.

Exclusion criteria

Exclusion Criteria:

  1. Physician prescribed procedures in the area of intended treatment in the previous 6 months (e.g., photodynamic therapy, intense pulsed light therapy, laser surgery).
  2. 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.
  3. History of melanoma.
  4. Known history of illness or adverse reaction to cold insult (e.g., cryoglobulinemia, cold urticaria, paroxysmal cold hemoglobinuria, Reynaud's disease).
  5. History of abnormal wound healing or abnormal scarring
  6. Inability or unwillingness to comply with the study requirements.
  7. Subject is pregnant or planning to become pregnant while enrolled in the study.
  8. Subject is lactating.
  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 increased or 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
34 participants (actual)

Study arms

  • Experimental
    Treatment with cryotherapy

    Dermal Cooling System

    Device: Dermal Cooling System

Interventions

  • DeviceDermal Cooling System

    Cryotherapy

05

What researchers measure

Primary outcomes

  1. Improvement in appearance in the treatment area

    Improvement in appearance in the treated area at the 3-month follow-up visit, as determined by the Physician Global Assessment (PGA).

    Time frame: 3-months

Secondary outcomes

  1. Incidence of procedure related adverse events

    • Safety of the treatment as determined by the incidence of device- or procedure-related serious adverse events

    Time frame: less than 12 months

06

Study locations

3 sites
  • Clear Dermatology & Aesthetics Center
    Scottsdale, Arizona 85255, United States
  • Zel Skin and Laser Specialists
    Edina, Minnesota 55424, 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
NCT03282994
Lead sponsor
R2 Dermatology
Responsible party
Sponsor
First posted
Sep 14, 2017
Start date
Jul 19, 2017
Primary completion
Nov 17, 2018
Completion
Nov 17, 2018
Last update
Aug 30, 2023

Study contacts

Kristine Tatsutani, PhD
study director · R2 Dermatology

Oversight

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

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This study is completed, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.

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