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 @ 11:34 PM
Ignite Modification Date:
2025-12-24 @ 11:34 PM
NCT ID:
NCT02735356
Eligibility Criteria:
Inclusion Criteria:
* The subject must sign and date all informed consent statements; children will sign the assent form and their guardian will sign the consent form
* The subject must be willing to apply the medications twice daily for 1 month
* The subjects must have at least four BCCs in non-cosmetically sensitive sites
* For women of child-bearing potential, a negative urine pregnancy test
* Women of child-bearing potential are expected to use an effective method of birth control to prevent exposing a fetus to potentially dangerous agent with unknown risk
* For male patients with female partners of childbearing potential, agreement to use adequate contraception while you are participating in the study and 1 month after applying your last dose
Exclusion Criteria:
* Pregnancy or breast-feeding
* History of congestive heart failure or other findings of ventricular dysfunction
* History of current evidence of malabsorption or liver disease
* Current immunosuppression or taking immunosuppressive drugs
* Taking oral itraconazole
* Taking any medication known to affect hedgehog (HH) signaling pathway
* The subject has used topical or systemic therapies that might interfere with the evaluation of the study medication during the study; specifically these include the topical use to the study tumors of: glucocorticoids (ii) retinoids (e.g., etretinate, isotretinoin, tazarotene, tretinoin, adapalene) systemically or topically (iii) alpha-hydroxy acids (e.g., glycolic acid, lactic acid) to more than 5% of the skin during the six months prior to study entry (iv) 5-fluorouracil or imiquimod; also - treatment with systemic chemotherapy or agents known to be inhibitors of HH signaling within 60 days to starting study medication
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02735356
Study Brief:
Protocol Section:
NCT02735356