PHOTOTHERAPY VERSUS PREGABALIN IN TREATMENT OF REFRACTORY UREAMIC PRURITIS

Alexandria University

Status and phase: Unknown; Phase 2

Conditions: Refractory Uremic Pruritis

Treatments: Device: NB UVB phototherapy; Drug: Pregabalin

Study type: Interventional

Funder types: Other

Identifiers

NCT04660773

0106476

Details and patient eligibility

About

Patients will be randomly assigned into 2 groups:

1. Group A: (20 patients) will receive NB UVB phototherapy 3 sessions per week for 2 months.
2. Group B: (20 patients) will receive pregabalin oral therapy (50mg after each dialysis session) for 2 months.

Enrollment: 40 estimated patients

Sex: All

Ages: 20 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age: 20-60 years.
2. End stage renal disease (the last stage(stage 5) of chronic disease which means kidneys are only functioning at 10 to 15 percent of their normal capacity and dialysis or kidney transplant is necessary to stay alive).
3. Refractory uremic pruritis.

Exclusion criteria

1. Other causes of pruritis (Dermatological or systemic) e.g. atopic, cholestatic liver disease.
2. Photosensitivity.
3. Contraindication or allergy to pregabalin.
4. Patients on antipruritic drugs e.g. antihistamines, steroids, emollients, opioid agonists.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

40 participants in 2 patient groups

NB UVB phototherapy

Active Comparator group

Description:

(20 patients) will receive NB UVB phototherapy 3 sessions per week for 2 months.

Treatment:

Device: NB UVB phototherapy

pregabalin

Active Comparator group

Description:

20 patients) will receive pregabalin oral therapy (50mg after each dialysis session) for 2 months.

Treatment:

Drug: Pregabalin