CTRI/2020/06/025826
Not yet recruiting
Phase 4
An observational study to evaluate the effectiveness and safety of Bilastine in patients with pruritus associated with skin disorders
SkinSpace Clinic0 sites0 target enrollmentTBD
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Health Condition 1: L299- Pruritus, unspecified
- Sponsor
- SkinSpace Clinic
- Status
- Not yet recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\.Both males and females patients aged \>\= 18 years and \<\= 60 years
- •2\.Patients with H/O pruritus associated with skin disorders
- •3\.Patients who are ready to give written informed consent, which includes a commitment to comply with all requirements, specified in the study protocol
- •4\.Patients who the study staff deems reliable and mentally competent to carry out the study
Exclusion Criteria
- •1\.Patients with physical urticaria (e.g. solar, heat, cold, aquagenic, cholinergic, contact, pressure, etc.), drug\-induced urticaria, urticarial vasculitis, senile pruritus or hereditary angioedema.
- •2\.Patients with pruritus due to metabolic diseases, neurologic disorders, endocrine diseases, psychiatric disorders, and cancer.
- •3\.Pregnant or nursing females.
- •4\.Patients with known hypersensitivity to the study drug.
- •5\.Patients with immunosuppressive disease or on immunosuppressive drugs.
- •6\.Evidence of clinically significant disease (e.g., cardiac, respiratory, gastrointestinal, renal disease) that in the opinion of the Investigator(s) could affect the subjectâ??s safety or interfere with the study assessments.
- •7\.Any history of or concomitant medical condition that in the opinion of the Investigator(s) would compromise the patientâ??s ability to safely complete the study.
- •8\.History of drug or alcohol dependency or abuse within approximately the last 2 years.
- •9\.Currently enrolled in another clinical study or used any investigational drug or device within 30 days preceding informed consent or were scheduled to participate in another clinical study that involved an investigational product or investigational drug during the course of this study.
Outcomes
Primary Outcomes
Not specified
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