None listed
Conditions
Brief summary
To study the safety of Ha44 after topical administration. Safety will be assessed by physical examination, including detailed assessment of scalp, face, eyes and ears, vital signs, 12-lead electrocardiogram, laboratory tests including haematology, clinical chemistry and urinalysis and adverse events. Ha44 is a novel insect ovicide.
Interventions
Ha44 is a novel insect ovicide. It is a lotion (0.37% or 0.74%) which is applied topically to the hair and scalp as a single dose at the start of the study. The lotion is washed off after 10 or 20 minutes.
Four groups will be studied, each group consisting of 8 subjects, 6 of whom will be treated with Ha44 and 2 with vehicle only. The vehicle onsists of a number of excipients, all of which are listed on the FDA database of inactive ingredients and within the allowed concentrations.
The first g
Ha44 is a novel insect ovicide. It is a lotion (0.37% or 0.74%) which is applied topically to the hair and scalp as a single dose at the start of the study. The lotion is washed off after 10 or 20 minutes. Four groups will be studied, each group consisting of 8 subjects, 6 of whom will be treated with Ha44 and 2 with vehicle only. The vehicle onsists of a number of excipients, all of which are listed on the FDA database of inactive ingredients and within the allowed concentrations. The first group will be treated with 0.37% Ha44 or vehicle for 10 minutes. After review of 7 day safety data, a second group will be treated with 0.37% Ha44 or vehicle for 20 minutes. After review of their 7 day safety data, a third group will be treated with 0.74% Ha44 or vehicle for 10 minutes. After review of 7 day safety data, a fourth group will be treated with 0.74% Ha44 or vehicle for 20 minutes.
Sponsors
Hatchtech Pty Ltd
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
Female subjects must be of non-childbearing potential and/or have a negative pregnancy test prior to study start and be deemed not at risk of becoming pregnant. Females of child bearing age who are sexually active must use two forms of contraception from screening until study completion Non smoker. Full head of hairMaximum hair length no more than 6 cmBody mass index between 18 and 28 kg/m2 inclusive, with body weight between 60-100 kgIn good health, as determined by screening assessmentsAble to provide written informed consent.
Exclusion criteria
Pregnant or breast-feeding femalesSubjects with a history of skin sensitisation or skin allergiesSubjects with abraded or abnormal skin on the area to be tested Subjects with any dermatological disease, including eczema, dermatitis, alopeciaSubjects who have taken any prescribed systemic or topical medication within two weeks prior to dosing, except for females on the contraceptive pill. Subjects who have taken any non-prescribed systemic or topical medication, except vitamins, within two weeks prior to dosing. Evidence of illicit drug use, as determined by a urine drug screenHistory of alcohol abuse Subjects with a known allergy to any of the components of the formulationPrevious treatment with an investigational agent within the last 30 daysAny condition which, in the opinion of the investigator, would prevent satisfactory participation in the study.
Outcome results
None listed