Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
For general information about clinical research, read Learn About Studies.
Eligibility Criteria
- 1. Healthy, female subjects 21-75 years of age who are seeking pre-treatment for the prevention of surgical scars.
- 2. Able to read, understand and voluntarily provide written Informed Consent.
- 3. Able and willing to comply with the treatment/follow-up schedule and requirements.
- 4. Willing to avoid direct sunlight to the treatment area for the duration of the study.
- 5. Women of child-bearing age are required to be using a reliable method of birth control at least 3 months prior to study enrollment and for the duration of the study, and have a negative Urine Pregnancy test at baseline.
- 1. Subjects with any implantable metal device in the treatment area
- 2. Pacemaker or internal defibrillator, or any other active electrical implant anywhere in the body (e.g. cochlear implant).
- 3. Permanent implant in the treated area, such as metal plates and screws, or an injected chemical substance.
- 4. Current or history of any kind of cancer, or dysplastic nevi.
- 5. Severe concurrent conditions, such as cardiac disorders.
- 6. Pregnancy or intending to become pregnant during the study and nursing.
- 7. Impaired immune system due to immunosuppressive diseases, such as AIDS and HIV, or use of immunosuppressive medications.
- 8. History of diseases stimulated by heat, such as recurrent herpes simplex in the treatment area; may be enrolled only following a prophylactic regime.
- 9. Poorly controlled endocrine disorders, such as diabetes.
- 10. Any active condition in the treatment area, such as sores, psoriasis, eczema, and rash.
- 11. History of skin disorders, such as keloids, abnormal wound healing, as well as very dry and fragile skin.
- 12. History of bleeding coagulopathies, or use of anticoagulants.
- 13. Use of isotretinoin (Accutane®) within six months prior to treatment or at physician discretion.
- 14. Treating over tattoo or permanent makeup.
- 15. Excessively tanned skin from sun, tanning beds or tanning creams within the last two weeks.
Ages Eligible for Study
21 Years to 75 Years
Sexes Eligible for Study
FEMALE
Accepts Healthy Volunteers
Yes