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 infestation

A Phase IIa Study to Determine the Safety, Tolerability and Absorption of Ha44 Gel Administered Topically to the Hair and Scalp of Subjects with Head Lice

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2009/091/000540

Enrollment

Registered

2009-07-23

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Ha44: Ha44 20 mM strength for 10 minutes exposure 2) Ha44 40 mM streength for 20 minutes exposure Control Intervention1: Placebo: 1) 10 minutes exposure 2) 20 minutes exposure

Eligibility

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

Measure	Time frame
safety and tolerability of Ha44 Gel after a single topical applicationTimepoint: Safety assessment - 28 days	—

Secondary

Measure	Time frame
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	—

Countries

India

Contacts

Public ContactDr. Nilesh Patel

Head of Clinical Operations (full time employee)

nileshp@dmricro.com02227642747

Outcome results