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 @ 4:09 AM
Ignite Modification Date:
2025-12-25 @ 4:09 AM
NCT ID:
NCT01084720
Eligibility Criteria:
Inclusion Criteria:
* Patients of both sexes, of at least 10 years of age
* Patients undergoing either hemodialysis or peritoneal dialysis due to chronic renal failure
* Patients whose xerosis is related to their renal insufficiency status
* Patients suffering from moderate to severe xerosis, i.e. with a severity score of at least 2, on two symmetric areas of the lower legs (Phase I test areas)
* Patients who have not experienced phototherapy within 8 weeks prior to study entry
* Patients with no antipruritic treatment, or with stable antipruritic treatments (e.g. antihistamines, cholestyramine, opioid inhibitors, charcoal) at least 4 weeks before study entry
* Written informed consent (Appendix II) from the patients or parents
Exclusion Criteria:
* Patients under 10 years of age
* Patients undergoing renal dialysis for another reason than MRD
* Patients whose xerosis or pruritus is due to another reason than their MRD status
* Patients suffering from mild xerosis (score £ 1) on the lower legs
* Patients with xerosis of non comparable severity between the lower legs
* Patients with a known history of allergy to one of the ingredients contained in the test product
* Patient with an intercurrent condition which may interfere with a good conduct or the study parameters of the study
* Patients treated with any other emollient/moisturizing topical preparation within the 7 days prior to study entry
* Patients with phototherapy within 8 weeks prior to study entry
* Patients who started an antipruritic treatment other than phototherapy, or who experienced unstable dosage schedule of antipruritic treatments (e.g. antihistamines, cholestyramin, opiod inhibitors, charcoal) within 4 weeks prior to study entry
* Patients who participated in a study within the 3 months prior to study entry
* Patients who are not able or willing to follow the study instructions
* Patients or parents who refuse to give written informed consent
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
10 Years
Study:
NCT01084720
Study Brief:
Protocol Section:
NCT01084720