National Study on the Epidemiology and Effectiveness of Therapies in the Treatment of Scabies

NCT07305961 | Completed

• 2 other identifiers: SID06RSO ID - 477
• Study Type: observational
• Target: 1,332
• Locations: 1 country
• Sites: 23

Brief Summary

Multicentre retrospective, prospective, non-profit, national observational study

Conditions

Scabies

Outcome Measures

Primary Outcomes (1)

• Healing Rate

  The cure rate is represented by the number of patients who were cured after the first treatment.

  From the date of enrolment until the date of healing, assessed up to 52 weeks.

Secondary Outcomes (5)

• Frequency of scabies diagnosis

  From the date of enrolment to the previous three years

• Epidemiological analyses

  at the end of the study

• body distribution

  Baseline

• presence/absence of clinical parameters

  Baseline

• presence/absence of language barriers

  Baseline

Study Arms (2)

prospective cohort

Patients diagnosed with scabies who attend outpatient clinics and their close contacts (household members and partners) at the various participating centres from the date of study approval until 31/12/2025 will be included, along with additional parameters regarding treatment, failures and epidemiological and clinical assessments.

Other: data collection

retrospective cohort

Only the number of registered scabies cases and the presence or absence of treatment failures will be considered; no clinical patient data will be extrapolated.

Other: data collection

Interventions

data collection OTHER

Biographical data: age; immunodeficiency; bedridden condition. Household data: number of people in the household, original state of the household, presence of paediatric cases weighing more or less than 15 kg, presence of a language barrier. Diagnostic criteria: clinical, dermatoscopic and/or microscopic. Clinical data: affected areas, non-specific therapies previously carried out. Days of isolation of the index case (if applicable). Treatment data: the first specific anti-mite therapy carried out, including the mode of administration; the number of days since the onset of the illness; the number of people treated per index case; the drug with which recovery was achieved (if known); and the time taken for recovery. Data for investigating treatment failures: answers to questions concerning treatment carried out with close contacts and cohabitants, correct information about environmental remediation implementation, number of therapy cycles carried out and follow-up timeframe.

prospective cohort

Eligibility Criteria

• Age: 6 Months - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients with scabies and their close contacts (household/partners) afferent to the outpatient clinics of participating Italian centers during the duration of the study will be included in the study.

You may qualify if:

• Patients of any age with clinical and/or dermoscopic and/or microscopic diagnosis of scabies.
• Close contacts (household/relatives) of patients diagnosed with scabies.
• Obtaining informed consent.

Sponsors & Collaborators

• Societa Italiana di Dermatologia Medica, Chirurgica, Estetica e di Malattie Sessualmente Trasmesse: lead

Study Sites (23)

Ospedale Cardinal Massaia

Asti, AT, 14100, Italy

Location

ASST Papa Giovanni XXIII

Bergamo, BG, 24127, Italy

Location

IRCCS AOU di Bologna

Bologna, BO, 40138, Italy

Location

Ospedali Riuniti di Foggia

Foggia, FG, 71122, Italy

Location

USL Toscana Centro

Florence, FI, 50100, Italy

Location

Azienda Ospedaliera Universitaria Meyer IRCCS

Florence, FI, 50139, Italy

Location

Ospedale Policlinico San Martino

Genova, GE, 16132, Italy

Location

AOU San Giovanni di Dio

Cagliari, Italy, CA, 09123, Italy

Location

APSS - Ospedale Santa Chiara

Trento, Italy/Trento, 38123, Italy

Location

ASST LECCO Alessandro Manzoni

Lecco, LC, 23900, Italy

Location

Ospedale Versilia

Lido di Camaiore, LU, 55041, Italy

Location

ASL Toscana Nord Ovest

Lucca, LU, 55100, Italy

Location

AOU Policlinico Gaetano Martino

Messina, Maine, 98124, Italy

Location

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

Milan, Michigan, 20122, Italy

Location

Fondazione Policlinico San Matteo IRCCS

Pavia, PV, 27100, Italy

Location

AUSL Della Romagna

Ravenna, RA, 48121, Italy

Location

Fondazione Policlinico Tor Vergata

Roma, RM, 00133, Italy

Location

Istituto San Gallicano

Roma, RM, 00144, Italy

Location

Regina Margherita Children's Hospital, Città della Salute e della Scienza di Torino

Torino, TO, 10126, Italy

Location

AOU S.Maria della Misericordia

Udine, UD, 33100, Italy

Location

Ospedale Civico Maggiore Borgo Trento

Verona, VR, 37126, Italy

Location

Università VANVITELLI

Naples, 80138, Italy

Location

AOU Maggiore della Carità

Novara, 28100, Italy

Location

MeSH Terms

Conditions

Scabies

Interventions

Data Collection

Condition Hierarchy (Ancestors)

Mite Infestations; Ectoparasitic Infestations; Skin Diseases, Parasitic; Parasitic Diseases; Infections; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2025
• First Posted: December 26, 2025
• Study Start: January 7, 2025
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: March 27, 2026

Record last verified: 2026-03

Locations

IT (23)