A clinical trial to check the efficacy, tolerability and systemic absorption of Ha44 following single dose topical application Ha44 formulation on hair and scalp of patients having head lice infestatio
- Registration Number
- CTRI/2009/091/000540
- Lead Sponsor
- Hatchtech Pty Ltd, 205-211 Grattan Street, Parkville VIC, 3052AUSTRALIATel: +6138344 3190, Fax: +6139347 5888
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 60
Male and female subjects who meet all of the following criteria can be entered into the study:
1. Diagnosis of head lice infestation
2. Age 18 to 50 years inclusive.
3. Body weight at least 45 kg for male subjects and 40 kg for female subjects.
4. Female subjects must use two forms of contraception (e.g. a hormonal contraception and barrier method contraception or two barrier methods [for females not on a hormonal contraceptive]) or vasectomy (> 6 months) or post-menopausal (no menses for > 2 years) documented for either the subject or their partner, from screening until study completion.
5. At least five live lice observed.
6. At least 5 louse eggs that appear viable, no more than 1 cm from the scalp.
7. In good health, with no major chronic diseases.
8. Informed consent obtained from subject.
Subjects who meet any of the following criteria will not be eligible for participation in this study:
1. Pregnant or breast-feeding females.
2. A history of scalp eczema.
3. Any current dermatological disease, including eczema, dermatitis, alopecia.
4. Current eye disease including allergic or infectious conjunctivitis.
5. 12-lead ECG demonstrating QTc > 450 msec for women or > 430 msec for men at screening, history or evidence of long QT syndrome or any other clinically significant ECG abnormality.
6. Treatment with a pediculicide or over-the-counter medicated shampoo within the last 2 weeks.
7. A known history of allergy or sensitivity to shampoo, hair conditioner or permethrin.
8. Treatment with medication in the last 7 days. This does not include acetaminophen (paracetamol), ibuprofen and over the counter non-steroidal anti-inflammatory drugs which are permitted up to 2 days before treatment when used as per labeled recommendations. Oral contraceptives are also permitted.
9. Previous treatment with an investigational agent within the last 30 days, and/or current participation in another clinical study.
10. Any condition which, in the opinion of the Investigator, would prevent satisfactory participation in the study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method safety and tolerability of Ha44 Gel after a single topical applicationTimepoint: Safety assessment - 28 days
- Secondary Outcome Measures
Name Time Method systemic exposure of Ha44 following single dose topical application of 20mM and 4mMTimepoint: 1) Systemic absorption - 24 hours 2) ovicidal activity - 45 minutes 3) lousicidal activity - 28 days