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Clinical Trials/2024-520348-40-00
2024-520348-40-00
Not yet recruiting
Phase 4

A Comparative Trial on Scabies Treatments: Topical Permethrin, Oral Ivermectin and Combination of Topical Permethrin and Oral Ivermectin

Giuliani S.p.A.3 sites in 1 country156 target enrollmentStarted: July 8, 2025Last updated:
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Overview

Phase
Phase 4
Status
Not yet recruiting
Sponsor
Giuliani S.p.A.
Enrollment
156
Locations
3
Primary Endpoint
Percentage of subjects (Score 0; see below) with Complete cure rate (CCR) at Visit 1 (week 1)
OverviewEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Overview

Brief Summary

To compare the clinical cure rate (CCR) of standard treatments of scabies (topical permethrin 5% vs. oral ivermectin or their combination) in the short-term clinical cure rate. A superiority trial.

Eligibility Criteria

Ages
18 years to 65+ years (65+ Years, 18-64 Years)
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •Male and female aged >18 years and <80 years
  • •Presence of uncomplicated scabies confirmed by dermatological evaluation and a positive scraping test demonstrating the presence of Sarcoptes Scabiei mites, their eggs or faecal pellets (scybala). If the patient has positive result it is recommended to also visit the cohabitants to whom to propose the study in case they are positive
  • •Immunocompetent
  • •Giving informed written consent to participate to the trial

Exclusion Criteria

  • •Subjects with crusted scabies
  • •Subjects HIV positive
  • •Antiscabietic treatments in the previous 4 weeks before entry into the study
  • •Pregnancy or breastfeeding
  • •Medical History with hepatic, cardiac or renal diseases
  • •Participant must not be simultaneously enrolled in any interventional clinical trial
  • •Women with childbearing potential if they do not agree with the use of highly effective contraceptive methods with low user dependency, or to be abstinent from heterosexual intercourse

Outcomes

Primary Outcomes

Percentage of subjects (Score 0; see below) with Complete cure rate (CCR) at Visit 1 (week 1)

Percentage of subjects (Score 0; see below) with Complete cure rate (CCR) at Visit 1 (week 1)

Secondary Outcomes

  • Percentage of subjects (Score 0; see below) with Complete cure rate (CCR) at Visit 2 (week 2)
  • Percentage of Subjects with score 0 or 1 at week 1
  • Percentage of subjects with CCR at week 2
  • Percentage of subjects with score 0 or 1 at week 2
  • Subjective evaluation of itching at week 1 and 2
  • Percentage of treatment failure at week 1 and week 2 (treatment failure is defined as: no improvement at all of itching intensity and skin lesions count and/or appearance of new lesions)
  • Safety and Tolerability endpoints: (at week 1, week 2) - Evaluation and recording of spontaneous reported adverse events - Blood pressure monitoring - Heart rate

Investigators

Sponsor
Giuliani S.p.A.
Sponsor Class
Pharmaceutical company
Responsible Party
Principal Investigator
Principal Investigator

Daniela Pinto

Scientific

Giuliani S.p.A.

Study Sites (3)

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