A observational study to see whether the medicine Bilastine is safe and effective when used in patients having skin infection that causes scratch or itch.

An observational study to evaluate the effectiveness and safety of Bilastine in patients with pruritus associated with skin disorders

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2020/06/025826

Enrollment

120

Registered

2020-06-11

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: L299- Pruritus, unspecified

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: 1. Both males and females patients aged >= 18 years and 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

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.

Design outcomes

Primary

Measure	Time frame
To assess the effectiveness of Bilastine in the management of pruritus associated with skin disorders.Timepoint: 4 weeks	—

Secondary

Measure	Time frame
Safety endpoint The incidences of treatment emergent adverse events (TEAEs), treatment related AEs and AEs/SAEs leading to study withdrawalTimepoint: 4 weeks;To assess the effectiveness of Bilastine in the improvement of quality of life of patients with h/o pruritus associated with skin disorders.Timepoint: 4 weeks	—

Countries

India

Contacts

Public ContactDr Abhay Talathi

SkinSpace Clinic

drabhaytalathi100@gmail.com8879428284

Outcome results