PHOTOTHERAPY VERSUS PREGABALIN IN TREATMENT OF REFRACTORY UREAMIC PRURITIS

Sponsor

Alexandria University (Other)

Overall Status

Recruiting

CT.gov ID

NCT04660773

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

5.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Patients will be randomly assigned into 2 groups:

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

Condition or Disease	Intervention/Treatment	Phase
Refractory Uremic Pruritis	Device: NB UVB phototherapy Drug: Pregabalin	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

NARROW BAND UVB PHOTOTHERAPY VERSUS PREGABALIN IN TREATMENT OF REFRACTORY PRURITIS IN END STAGE RENAL DISEASE PATIENTS

Anticipated Study Start Date :

Aug 1, 2021

Anticipated Primary Completion Date :

Mar 1, 2022

Anticipated Study Completion Date :

Mar 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: NB UVB phototherapy (20 patients) will receive NB UVB phototherapy 3 sessions per week for 2 months.	Device: NB UVB phototherapy ultraviolet phototherapy sessions
Active Comparator: pregabalin 20 patients) will receive pregabalin oral therapy (50mg after each dialysis session) for 2 months.	Drug: Pregabalin oral medication

Arm

Intervention/Treatment

Active Comparator: NB UVB phototherapy

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

Device: NB UVB phototherapy

ultraviolet phototherapy sessions

Active Comparator: pregabalin

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

Drug: Pregabalin

oral medication

Outcome Measures

Primary Outcome Measures

5 D-itching scale [two month]
assessment of degree, duration, direction, disability and distribution of itching

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Age: 20-60 years.
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).
Refractory uremic pruritis.

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Faculty of Medicine	Alexandria		Egypt	21521

Sponsors and Collaborators

Alexandria University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

marwa eldeeb, lecturer of dermatology, Alexandria University

ClinicalTrials.gov Identifier:

NCT04660773

Other Study ID Numbers:

0106476

First Posted:

Dec 9, 2020

Last Update Posted:

Jul 26, 2021

Last Verified:

Jul 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Yes

Product Manufactured in and Exported from the U.S.:

Yes

Additional relevant MeSH terms:

Pruritus

Pregabalin

Study Results

No Results Posted as of Jul 26, 2021