None listed
Conditions
Interventions
Intervention1: SR-10 anti-lice drops and SR-20 anti-lice shampoo: Product 1: Anti-lice Drops(Formula No. SR-10-Drops)
Product 1 will be applied in sufficient quantity and gently massaged to
cover enti
Sponsors
Dabur Research Foundation
Eligibility
Inclusion criteria
Inclusion criteria: 1 Healthy Indian male and female subjects 2 Age from 3 to15 years (both inclusive) 3 Subjects presenting with lice infestation of scalp and having at least five live lice and five eggs 4 Subjects with short , medium or long length hair 5 Subjects with straight or wavy or curly hair. 6 Subject willing and capable to follow the study rules and a fixed schedule 7 Subject/ Subjectâ??s LAR able to give written informed consent and to comply with the requirements of the study
Exclusion criteria
Exclusion criteria: 1 Subjects not matching one of the above mentioned inclusion criteria 2 Subject having any acute skin irritation or diseases on the application site 3 Known hypersensitivity to any of the study products or constituents (positive reaction in Epicutaneous sensitivity testing) 4 Any significant medical condition or drug history that would interfere with the study assessments 5 Subjects with dermatological disorders which could interfere with the evaluation of the product tested 6 Subjects with intellectual/ mental inability to follow study instructions (if suspected) or incapacitation 7 Participation in any other clinical trial up to 1 month prior to inclusion and during the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluation of anti-lice efficacy of investigational products in comparision to a already marketed product by count of lice and nymphs before and after product applicationTimepoint: T0 (before product application) & T30 (approximately 30 minutes after initiation of product application) at Day 0 and Day 10, and at a single time point on Day 5 and Day 14 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.The number of reported AE/ LI throughout the study will be used to assess the cutaneous safety and tolerance by the investigator 2. Perception of efficacy, tolerance and organoleptic characteristics of the product through responses to subjective evaluation questionnaire by subjects/subjectâ??s LAR 3. Count of eggs which hatch into nymphs after incubation of eggs collectedTimepoint: 1.Evaluation of number of AE/LI reported through out the study 2.Subjective evaluation questionnaire by subjects/subjectâ??s LAR at Day 0 (T0 & T30min), Day 5, Day 10 (T30min) and Day 14 3.Collection of eggs at Day0T0 ,Day0T30 min,Day10T0 and Day10T30min | — |
Countries
India
Contacts
Public ContactDeepika Arora
CIDP Biotech India Pvt. Ltd
Outcome results
None listed