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

Prospective non-controlled evaluation study on the quality of life and patient-relevant treatment benefit of hospitalized patients with treatment refractory scabies - SCA813

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00032950

Enrollment

100

Registered

2024-02-22

Start date

2024-02-26

Completion date

Unknown

Last updated

2025-04-07

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

Conditions

B86

Interventions

Group 1: Patients admitted for acute inpatient treatment of therapy-resistant scabies (number of unsuccessful therapy attempts in the last 12 months = 3 and/or recurrent scabies infections in the last

patient-relevant therapy benefit, patient satisfaction)) and NRS Pruritus ((Numerical Rating Scale (NRS), pruritus assessment)) as well as at the follow-up visit (V3) using DLQI or CDLQI, PBI-Scab or

Eligibility

Sex/Gender

All

Age

5 Years to No maximum

Inclusion criteria

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 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

Design outcomes

Primary

Measure	Time frame
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).	—

Measure

Time frame

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

Measure	Time frame
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.	—

Measure

Time frame

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.

—

Countries

Germany

Contacts

Public ContactAthanasios Tsianakas

Fachklinik Bad Bentheim

a.tsianakas@fk-bentheim.de(05922) 74-52 10

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026