Dermal Cooling System for Cryotherapy of Common Skin Conditions

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-19

Study Completion Date

2018-11-17

Brief Summary

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

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Detailed Description

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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.

Conditions

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Skin Lesion

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment with cryotherapy

Dermal Cooling System

Group Type EXPERIMENTAL

Dermal Cooling System

Intervention Type DEVICE

Cryotherapy

Interventions

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Dermal Cooling System

Cryotherapy

Intervention Type DEVICE

Eligibility Criteria

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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

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes