Pediculosis capitis MedDRA version: 16.1 Level: LLT Classification code 10019199 Term: Head pediculosis System Organ Class: 100000004862
Conditions
Interventions
Trade Name: Hedrin 4% Lotion
Product Name: Hedrin 4% Lotion
Pharmaceutical Form: Cutaneous solution
INN or Proposed INN: Dimeticone
Concentration unit: % (V/V) percent volume/volume
Concentration type
Sponsors
G. Pohl-Boskamp GmbH & Co. KG
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Is the application of NEX with two applications non inferior to Hedrin® in controlling head lice infestations?;Secondary Objective: Secondary endpoints include: 1. Absence of viable head lice on Day 1 and Day 7. 2. Assessment of development stages of lice and gender in case of adult lice. 3. Subjective assessment on a Verbal Rating Scale (VRS) of global efficacy and tolerability by participants and investigator (blinded observer). 4. Clinical assessment of scalp pathology in regard to conditions related with head lice infestation (evaluation of the skin/scalp for erythema, papules, excoriations, eczema, pyoderma, superinfected excoriations and enlarged cervical or retro-auricular lymph nodes) 5. Clinical assessment of the local tolerability (evaluation of the skin/scalp for erythema and edema, evaluation for the presence / absence of ocular irritation) 6. Participant’s assessment of pruritus using a ordinal visual scale 7. Recording of the amount of IMD / IMP needed for treatment;Primary end point(s): The primary efficacy endpoint is the rate of treatment success, defined as absence of any viable head lice on Day 10: Evaluation for non-inferiority of NEX to the comparator, with a non-inferiority margin of 10% based on the Per Protocol (PP) Set.;Timepoint(s) of evaluation of this end point: Presence of head lice will be evaluated on Day 10 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Absence of viable head lice (category 1 and 2) on Day 1 and 7 2. Assessment of development stages of lice and gender in case of adult lice 3. Subjective assessment (VRS) of global efficacy and tolerability by subject and investigator / clinical research nurse (blinded observer) 4. Clinical assessment of scalp pathology in regard to conditions related with head lice infestation (evaluation of the skin/scalp for erythema, papules, excoriations, eczema, pyoderma, super -infected excoriations and enlarged cervical or retro-auricular lymph nodes) 5. Clinical assessment of the local tolerability (evaluation of the skin/scalp for erythema and oedema, evaluation for the presence/absence of ocular irritation) 6. Subject’s assessment of pruritus using a ordinal visual scale 7. Recording of the amount of IMD/IMP needed for treatment;Timepoint(s) of evaluation of this end point: Day 1: Absence of lice, developmental stage of lice found, clinical assessment of scalp pathology Day 7: Absence of lice, developmental stage of lice found, clinical assessment of scalp pathology, recording of IMP/IMD used. Day 10: Developmental stage of lice found, subjective and clinical assessment of tolerability, clinical assessment of scalp pathology. Recording of IMP/IMD used. | — |
Countries
United Kingdom
Outcome results
None listed