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:
2025-12-24 @ 11:07 PM
Ignite Modification Date:
2025-12-24 @ 11:07 PM
NCT ID:
NCT01713569
Eligibility Criteria:
Inclusion Criteria:
* Male or female, age 30 to 65 years scheduled for rhytidectomy.
* Subject in good health.
* Understands and accepts the obligation not to undergo any other procedures in the areas to be treated.
* Willingness and ability to comply with protocol requirements, including returning for follow-up visits and abstaining from exclusionary procedures for the duration of the study.
* Subjects of childbearing potential must have a negative urine pregnancy test result and must not be lactating at Visit 1 and be willing and able to use an acceptable method of birth control (e.g., barrier methods used with a spermicidal agent, hormonal methods, IUD, surgical sterilization, abstinence) during the study. Women will not be considered of childbearing potential if one of the following conditions is documented on the medical history: a) Postmenopausal for at least 12 months prior to study; b) Without a uterus and/or both ovaries; or c) A bilateral tubal ligation at least six months prior to study enrollment.
Exclusion Criteria:
* Presence of an active systemic or local skin disease that may affect wound healing.
* Severe solar elastosis.
* Significant scarring in areas to be treated.
* Open wounds or lesions in the area to be treated.
* Severe or cystic acne on the area to be treated.
* Presence of a metal stent or implant in the facial area to be treated.
* Inability to understand the protocol or to give informed consent.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
30 Years
Maximum Age:
65 Years
Study:
NCT01713569
Study Brief:
Protocol Section:
NCT01713569