Evaluation of a New Dermal Cryotherapy System

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

175 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-04-27

Study Completion Date

2018-06-12

Brief Summary

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A pilot study to evaluate the feasibility of altering skin pigmentation using the Dermal Cooling System.

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Detailed Description

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This non-significant risk study is being performed to test the hypothesis that a new treatment concept, controlled localized cooling of the epidermal layer, can be used to lighten areas of the skin.

Conditions

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Skin Lightening

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

Treatment with dermal cooling system.

Group Type EXPERIMENTAL

Dermal Cooling System

Intervention Type DEVICE

Treatment with cryotherapy.

Interventions

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Dermal Cooling System

Treatment with cryotherapy.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Male or female subjects \> 18 years of age.
2. Subject is willing to have up to 40 test sites treated on aesthetically discreet skin.
3. Subject is willing to use photoprotection (e.g., sun avoidance) of the treated areas during the duration of the follow-up period.
4. Subject has read and signed a written informed consent form.

Exclusion Criteria

1. Fitzpatrick skin type VI.
2. Physician prescribed, medical or surgical treatment in the area of intended treatment in the previous 6 months (e.g., hydroquinone, corticosteroids, laser surgery)
3. Artificial tanning in the area of intended treatment within 1 month (e.g., spray, lotion, tanning bed) or intention to use artificial tanning within the follow-up period
4. Dermatological conditions or scars in the location of the treatment sites
5. History of melanoma, personal or first degree relative
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 study requirments.
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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes