Overview
Sponsor-declared trial summary
Phase
Therapeutic use (Phase IV)
Status
Ongoing, recruiting
Participants planned
156
Countries
1
Sites
3
Clinical and light microscopy confirmed scabies
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.
Key facts
- Sponsor
- Giuliani S.p.A.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Skin and Connective Tissue Diseases [C17]
- Trial duration
- 2 Oct 2025 → ongoing
- Decision date (initial)
- 2025-07-08
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy
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.
Secondary objectives 1
- To compare the clinical cure rate (CCR) of standard treatments of scabies (topical permethrin 5% vs. oral ivermectin or their combination) in the long term clinical cure rate. To evaluate safety and tolerability.
Conditions and MedDRA coding
Clinical and light microscopy confirmed scabies
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 4
- 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 7
- 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
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Percentage of subjects (Score 0; see below) with Complete cure rate (CCR) at Visit 1 (week 1)
Secondary endpoints 7
- 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
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 2
PRD11200174 · Product
- Active substance
- Permethrin (Cis:trans 25:75)
- Pharmaceutical form
- CREAM
- Route of administration
- CUTANEOUS USE
- Max daily dose
- 30 g gram(s)
- Max total dose
- 210 g gram(s)
- Max treatment duration
- 7 Day(s)
- Authorisation status
- Authorised
- ATC code
- P03AC04 — PERMETHRIN
- Marketing authorisation
- 036290017
- MA holder
- GIULIANI SPA
- MA country
- Italy
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
IVERMECTINA GIULIANI 3 mg compresse
PRD11410214 · Product
- Active substance
- Ivermectin
- Substance synonyms
- L-640471, EQU-001, CD5024, MK-933
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 200 µg/Kg microgram(s)/kilogram
- Max total dose
- 400 µg/Kg microgram(s)/kilogram
- Max treatment duration
- 2 Day(s)
- Authorisation status
- Authorised
- ATC code
- P02CF01 — IVERMECTIN
- Marketing authorisation
- 049873033
- MA holder
- GIULIANI SPA
- MA country
- Italy
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Giuliani S.p.A.
- Sponsor organisation
- Giuliani S.p.A.
- Address
- Via Pelagio Palagi 2
- City
- Milan
- Postcode
- 20129
- Country
- Italy
Scientific contact point
- Organisation
- Giuliani S.p.A.
- Contact name
- Daniela Pinto
Public contact point
- Organisation
- Giuliani S.p.A.
- Contact name
- Roberto Novellini
Third parties 1
| Organisation | City, country | Duties |
|---|---|---|
| Gb Pharma S.r.l. ORG-100001300
|
Milan, Italy | On site monitoring, Code 11, Code 12, Code 2, Code 5, Data management, E-data capture, Code 8 |
Locations
1 EU/EEA country · 3 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Italy | Ongoing, recruiting | 156 | 3 |
| Rest of world | — | 0 | — |
Investigational sites
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Dermatologia, Via Pace 9, 20122, Milan
Hospital Santa Maria Della Misericordia
Dermatologia, Piazzale Giorgio Menghini 1, 06129, Perugia
Fondazione Policlinico Universitario Campus Bio-medico In Forma A Bbreviata Fon
Dermatologia, Via Alvaro Del Portillo N 200, 00128, Rome
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Italy | 2025-10-02 | 2025-10-23 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 9 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol_2024-520348-40-00_for publication | 5 |
| Protocol (for publication) | D4_Patient facing document_diary | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_IT for publication | 2 |
| Subject information and informed consent form (for publication) | L2_Privacy ICF_IT | 1 |
| Subject information and informed consent form (for publication) | L3_GP Letter_IT | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Ivermectina Giuliani | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Scabiacid | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_2024-520348-40-00 IT_for publication | 5 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-04-04 | Italy | Acceptable 2025-07-07
|
2025-07-08 |