Clinical Evaluation of a herbal formulation for head lice

Phase 2

• Conditions: Health Condition 1: B850- Pediculosis due to Pediculus humanus capitis

• Registration Number: CTRI/2024/05/067198
• Lead Sponsor: Dabur India Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 27 May 2024

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified