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 @ 1:25 AM
Ignite Modification Date:
2025-12-25 @ 1:25 AM
NCT ID:
NCT00847093
Eligibility Criteria:
Inclusion Criteria:
* Subject is 3 months to less than 3 years of age (at least 3 months old but not yet reached his 3rd birthday at the time of enrollment).
* Subject has presented with a clinical diagnosis of buried penis
* With the exception of the disease being studied, subject is in good health in the opinion of the investigator.
* Subject and parent(s) or legal guardian(s) must agree to the requirements and restrictions of the study and will appear for all required examinations.
* Subject's parent or legal guardian must sign a written, IRB-approved informed consent prior to admission into the study, and must be able to understand that consent form.
Exclusion Criteria:
* Subject has a known hypersensitivity to any component of the study medication.
* Subject has history or evidence of other conditions that would interfere with evaluation of the study medication.
* Subject has been treated with another investigational device or drug within 30 days prior to study enrollment, or is participating in a clinical trial at the time of enrollment or intends to participate in a clinical trial concurrent with this study.
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
3 Months
Maximum Age:
3 Years
Study:
NCT00847093
Study Brief:
Protocol Section:
NCT00847093