Health Condition 1: B850- Pediculosis due to Pediculus humanus capitis
Conditions
Interventions
None listed
Sponsors
Dabur India Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Provision of signed and dated informed consent prior to any study-specific procedures. 2. More than 3 years to 16 years of age; male/female) will be included after head lice infestation will be confirmed. Full scalp and hair diagnoses will be performed by experienced clinical staff using a plastic head lice comb. The severity of the head lice infestation will be classified as follows: none (0), mild (less than 3 lice or nymph) (1), moderate (between 3 and 6 lice or nymph) (2), or severe (more than 6 lice or nymph) (3). 3. Only subjects with a mild, moderate, or severe infestation, and a good general condition will be included in the study. 4. Informed consent and assent will be obtained as applicable.
Exclusion criteria
Exclusion criteria: 1. Participants who in Investigator’s opinion will not be able to follow study procedures. 2. Participants who have used any head lice treatment within 4 weeks of enrolment will be not included in the study. 3. Large injuries or disease, especially of the scalp, which would make another preferable medical care necessary (e.g. impetigo, eczema), chronic scalp disorders (e.g. psoriasis, chronic dermatosis of unknown origin) and secondary infections of the scalp. 4. Hypersensitivities or allergies to one or more ingredients of the test product or the reference products 5. Skin allergies, multiple drug allergies or multiple allergies to cosmetic products. 6. Treatments with antibiotics (e.g. co-trimoxazole, trimethoprim, tetracycline) or anti-helminthic (e.g. ivermectin, levamisole, albendazole) in the last 30 days or imminent and other topical or systemic drug treatments, which in the investigators’ view would bias the study results.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome measure will be the relieving rate, defined as the percentage of subjects relieved from pediculosis infestation after application of the treatment. Determination of the cure rate will be performed by the investigator on the basis of visual inspection for viable nits, nymphs, hatching nymphs, and adult lice (with a magnifying lens) and combing with a head louse catching comb. The lice will be counted, and the infestation will be scored as none (0), mild (less than 3 lice or nymph or ) (1), moderate (between 3 and 6) (2), or severe (more than 6 lice) (3) Timepoint: Pre and post treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Intensity of pruritus on a Visual Analogical Scale (VAS). 2. Clinical scoring of dryness, redness, irritation, and flakiness of scalp (0 absence, 1 light, 2 moderate, 3 severe). 3. Clinical scoring of irritation, discomfort, and itching in order to assess the side effects of the product (0 absence, 1 light, 2 moderate, 3 severe). 4. At each visit the parent’s opinion will be recorded regarding the workload required to perform the intervention. The subjects will be also questioned about any irritation, discomfort, embarrassment, or other symptoms associated with the use of this treatment. 5. Assessment of Quality of life improvement basis CDLQ Index. 6. Product Acceptability, & Tolerability Timepoint: 0, 7, 14, 21, 28 days | — |
Countries
India
Contacts
Public ContactDr Baidyanath Mishra
Dabur India Limited
Outcome results
None listed