Health Condition 1: L088- Other specified local infections of the skin and subcutaneous tissue
Conditions
Interventions
Intervention1: Ivermectin Lotion 0.5% w/w: One tube of lotion is to be applied for 10 minutes to coat the hair and scalp. Rinse off with water. Use sterile hand gloves during application of the lotion
Sponsors
Ajanta Pharma Ltd
Eligibility
Inclusion criteria
Inclusion criteria: Subjects meeting all of the following criteria will be recruited for the trial: 1. Healthy males, non-pregnant females and children of age >=6 months to 2. Subjects must have an active head lice infestation of atleast three live lice and/or viable nits. (Viability of nits to be determined by using magnifying lens at a distance of less than 0.6 cm/6 mm from the scalp). 3. Following application and rinsing of the test article, subject agrees not to shampoo, wash, or rinse their hair or scalp until the 24 hour post treatment evaluation has been completed. 4. Subject agrees not to cut or chemically treat their hair while participating in the study. 5. Subject and/or parent/guardian agree that the subject will not use any other form of lice treatment during the duration of the study. 6. Subjects who are willing to sign informed consent for participation in the study and willing to adhere to all protocol procedures. Caregivers who are willing to sign Informed Consent agreement for children of age =7 years who are willing to sign a childâ??s assent form.
Exclusion criteria
Exclusion criteria: Subjects will be excluded if ANY of the following conditions apply: 1. Female subjects who are pregnant or lactating or planning to become pregnant during the study period. Females who are not ready to use acceptable contraceptive methods during the course of study. 2. Scalp condition that could make it difficult to evaluate the extent and severity of an infestation or that would present a problem in the evaluation of response to therapy (e.g. psoriatic scalp lesions, extensive seborrheic dermatitis). 3. Treatment for head lice (OTC, home remedy and/or prescription drugs) in the last 7 days. 4. Subject who used any hair dye, bleaches, hair straightening or permanent wave solution on the hair within 14 days of randomization. 5. Known history of irritation or sensitivity to pediculicides or hair care products. 6. Subjects with known allergy or hypersensitivity to Ivermectin or any component of the test product. 7. Any condition or illness that may compromise the objective of the protocol. 8. Subject receiving any other treatment which may interfere with the study results. 9. Participation in a previous investigational drug study within the past 30 days. 10. Does not understand the requirements for study participation and/or may likely exhibit poor compliance.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the efficacy of Ivermectin Lotion 0.5% w/w Versus Vehicle Control in lice infested subjects.Timepoint: at the end of 2 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the safety of Ivermectin Lotion 0.5% w/w Versus Vehicle Control in lice infested subjectsTimepoint: at the end of 2 weeks | — |
Countries
India
Contacts
Public ContactDr Shailesh Singh
Ajanta Pharma Ltd
Outcome results
None listed