Prospective non-controlled evaluation study on the quality of life and patient-relevant treatment benefit of hospitalized patients with treatment refractory scabies

Recruiting

• Conditions: B86; Scabies

• Registration Number: DRKS00032950
• Lead Sponsor: Fachklinik Bad Bentheim

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-02-22
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Patients aged 5 years and older, diagnosed with therapy-refractory scabies, defined as having had three or more unsuccessful treatment attempts in the last 12 months and/or experiencing recurrent scabies infestations in the past three months.

Exclusion Criteria

- Exclusion of individuals dependent on sponsor, study coordinator or attending physician
- Exclusion of patients incapable of accurately and truthfully completing the questionnaires
- Exclusion of patients lacking the capacity to provide informed consent

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
High and sustained patient-relevant therapeutic benefit of inpatient treatment of patients with refractory scabies, measured by the PBI-Scab or PBI-Scab-K (Patient Benefit Index questionnaire version specially developed for scabies) at the beginning (admission, V1, day 1) and at the end (discharge, V2, approx. day 7) of the inpatient stay and after approx. 6-8 weeks after the inpatient stay (follow-up, V3).

Secondary Outcome Measures

Name	Time	Method
Comparison of the (sustained) improvement in pruritus (using the Numerical Rating Scale (NRS) pruritus questionnaire and medical assessment of clinical findings) and quality of life (Dermatological Quality of Life Index (DLQI) questionnaire or CDLQI for children) following successful inpatient scabies eradication therapy, compared at the beginning (admission, V1, day 1) and end (discharge, V2, approx. day 7) of the inpatient stay and approx. 6-8 weeks afterwards in a follow-up visit (V3) in our dermatological outpatient clinic.