Efficacy of a new head lice treatment based on silicon oil

Completed

Conditions: Active head lice infestation
Infections and Infestations
Pediculosis and phthiriasis

Registration Number: ISRCTN15117709

Lead Sponsor: Mandacaru Foundation (Brazil)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 146

Inclusion Criteria

1. Children aged 5 - 15 years, either sex
2. An active head lice infestation (one or more active head lice found after three minutes of visual inspection)
3. Written consent obtained from study participants and carers

Exclusion Criteria

1. Use of head lice products, anthelminthics, or antibiotics within the previous four weeks
2. Severe skin disorders of the scalp (such as generalised impetigo, eczema, psoriasis or chronic dermatitis of unknown origin)
3. Bleached or colour treated hair within the previous four weeks
4. Known sensitivity to any ingredients in the products
5. Mental disease
6. Drug abuse
7. Pregnant or lactating girls
8. Unwillingness to stay for nine days in a holiday resort outside the endemic area where the clinical trial would be carried out
9. Participation in another clinical study in the previous month

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary outcome measure was defined as the proportion of participants cured of head lice infestation one, six and eight days after the first treatment (i.e. days 2, 7 and 9, respectively). Cure was defined as the complete absence of viable lice on the scalp, as determined by wet combing with a high quality plastic head louse comb.

Secondary Outcome Measures

Name	Time	Method
1. Reduction of clinical pathology: days 1 (before intervention), 2, 4, 7 and 9<br>2. Reduction of the degree of itching (assessed based on a pre-tested ordinal Visual Analogue Scale [VAS] ranging from 0 to 4): days 1 (before intervention), 2, 3, 4, 5, 6, 7, 8 and 9<br>3. Cosmetic acceptability of the products, assessed using a summary score ranging from -4 (extremely negative) to +4 (extremely positive), with a standardised questionnaire including subjective assessment of smelling, irritation of scalp, cosmetic changes of hair, and changes in the easiness to comb the hair: days 2, 4, 7 and 9<br>4. Safety (number and type of adverse events). Clinical pathology included the presence of erythema, papules, excoriations, eczema, secondary infection and enlarged cervical or retro-auricular lymph nodes: days 2, 4, 7 and 9 (and continuous documentation when any adverse event [AE] occurred, indendent from timepoints).