PERMETHRIN (CIS:TRANS 25:75) for Scabies

Inclusion criteria

• {"criterion_text":"- Male and female aged >18 years and <80 years\n- 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\n- Immunocompetent\n- Giving informed written consent to participate to the trial"}

Exclusion criteria

• {"criterion_text":"- Subjects with crusted scabies\n- Subjects HIV positive\n- Antiscabietic treatments in the previous 4 weeks before entry into the study\n- Pregnancy or breastfeeding\n- Medical History with hepatic, cardiac or renal diseases\n- Participant must not be simultaneously enrolled in any interventional clinical trial\n- 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"}

Primary endpoints

• {"endpoint_text":"- Percentage of subjects (Score 0; see below) with Complete cure rate (CCR) at Visit 1 (week 1)","definition_or_measurement_approach":"Percentage of subjects achieving Score 0 (complete cure) measured at Visit 1 (week 1)."}

Secondary endpoints

• {"endpoint_text":"- Percentage of subjects (Score 0; see below) with Complete cure rate (CCR) at Visit 2 (week 2)","definition_or_measurement_approach":"Percentage of subjects achieving Score 0 (complete cure) measured at Visit 2 (week 2)."}
• {"endpoint_text":"- Percentage of Subjects with score 0 or 1 at week 1","definition_or_measurement_approach":"Percentage of subjects with score 0 or 1 measured at week 1."}
• {"endpoint_text":"- Percentage of subjects with CCR at week 2","definition_or_measurement_approach":"Percentage of subjects achieving Complete Cure Rate (CCR) at week 2."}
• {"endpoint_text":"- Percentage of subjects with score 0 or 1 at week 2","definition_or_measurement_approach":"Percentage of subjects with score 0 or 1 measured at week 2."}
• {"endpoint_text":"- Subjective evaluation of itching at week 1 and 2","definition_or_measurement_approach":"Participant-reported subjective evaluation of itching assessed at week 1 and week 2."}
• {"endpoint_text":"- 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)","definition_or_measurement_approach":"Percentage of subjects meeting the protocol definition of treatment failure (no improvement in itching intensity and skin lesion count and/or appearance of new lesions) assessed at week 1 and week 2."}
• {"endpoint_text":"- Safety and Tolerability endpoints: (at week 1, week 2) - Evaluation and recording of spontaneous reported adverse events - Blood pressure monitoring - Heart rate","definition_or_measurement_approach":"Safety and tolerability assessed by recording spontaneously reported adverse events and measuring blood pressure and heart rate at week 1 and week 2."}

Italy

Earliest CTIS Part Ii Submission Date

26-06-2025

Latest Decision Or Authorization Date

08-07-2025

Processing Time Days

12

Number Of Sites

3

Number Of Participants

156

Primary sponsor

Full Name

Giuliani S.p.A.

Organisation Type

Pharmaceutical company

Country Of Registered Address

Italy

Third parties

• {"country":"Italy","full_name":"Gb Pharma S.r.l.","duties_or_roles":"sponsorDuties codes: 1,11,12,2,5,6,7,8","organisation_type":"Pharmaceutical company"}