Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:45 AM
Ignite Modification Date:
2025-12-25 @ 1:45 AM
NCT ID:
NCT02744794
Eligibility Criteria:
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.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02744794
Study Brief:
Protocol Section:
NCT02744794