EX in head lice infestatio

• Conditions: Pediculosis capitis; MedDRA version: 16.1Level: LLTClassification code 10019199Term: Head pediculosisSystem Organ Class: 100000004862; Therapeutic area: Diseases [C] - Parasitic Diseases [C03]

• Registration Number: EUCTR2013-004860-78-GB
• Lead Sponsor: G. Pohl-Boskamp GmbH & Co. KG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01-13
• Last Update Posted: 4 August 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 194

Inclusion Criteria

1. Healthy subjects without confounding disease and/or medication with head lice;
2. Male and female subject ages 2 to 11 years (inclusive);
3. Outpatients;
4. Presence of at least 3 viable head lice after visual inspection of the scalp;
5. The physical examination of the scalp must be without abnormal findings (except the symptoms due to head lice infestation) unless the investigator considers an abnormality to be irrelevant to the outcome of the clinical investigation;
6. For subjects aged 8-11 years: subjects willing and able to sign written informed assent and written informed consent obtained from their parent(s)/legal guardian(s). For subjects under 8 years: written informed consent obtained from their parent(s)/legal guardians.
Are the trial subjects under 18? yes
Number of subjects for this age range: 194
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range 0
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

1. Treatment with other head lice products within two weeks before and during the clinical investigation;
2. Treatment with antibiotics (e.g. cotrimoxazole, trimethoprim or tetracycline) within four weeks before and during the clinical investigation;
3. Treatment with anthelminthic drugs (e.g. ivermectin, levamisole or albendazole) within four weeks before and during the clinical investigation;
4. Severe skin disorder of the scalp (e.g. generalized impetigo, eczema, psoriasis or chronic dermatitis of unknown origin);
5. Usage of lice combs during the clinical investigation by the participants themselves or by the parent(s)/legal guardian(s);
6. Use of shampoos containing dimeticone during the investigation;(a dimeticone -free shampoo such as Johnson’s Baby Shampoo will be provided for all participants by the sponsor);
7. Use of hair bleaches, dyes, or permanent wave products during the investigation;
8. Symptoms of a clinically significant illness that may influence the outcome of the investigation in the four weeks before and during the clinical investigation;
9. Participation in the treatment phase of another clinical investigation or trial within the last four weeks prior to the first administration of IMD / IMP in this clinical investigation and during the clinical investigation;
10. Enrolment of a family member in the clinical investigation;
11. Known hypersensitivity or allergic reactions to components of the IMD / IMP;
12. Hair condition/texture prevents 100 ml IMD/IMP to be sufficient for one application in the opinion of the study nurse. Special attention should be paid to subjects whose hair length falls below mid-back
13. Contraindications according to the instructions for use and information given in the IB;
14. If in the opinion of the investigator or the clinical research nurse performing the initial examination the subject should not participate in the clinical investigation, e.g. due to probable noncompliance or inability of the subject or parent(s)/legal guardian(s) to understand the investigation and give adequately informed consent/assent;
15. Close affiliation with the investigator (e.g. a close relative) or persons working at LSHTM or the subject or subject’s parent(s)/legal guardian(s) is an employee of the sponsor;
16. Subject is institutionalized because of legal or regulatory order.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified