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A randomised, controlled, assessor-blind, clinical trial to demonstrate superiority of Hedrin 4% dimeticone lotion compared with Derbac-M 0.5% malathion aqueous liquid in the treatment of head lice

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN47755726
Enrollment
73
Registered
2006-12-27
Start date
2006-10-01
Completion date
Unknown
Last updated
2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Head louse infestation Infections and Infestations Head lice

Interventions

Dimeticone 4% lotion (Hedrin 4% lotion): The product will be applied directly to dry hair. Sufficient product will be applied to saturate the hair and scalp. The product will be left in place for e

Sponsors

Thornton & Ross Ltd (UK)
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Participants aged six months and over with no upper age limit 2. Participants who, upon examination, are confirmed to have live head lice 3. Participants who give written informed consent, or if the participant is under 16 years of age whose parent/guardian gives written informed consent to participate in the study 4. Participants who will be available for home visits by Medical Entomology Centre (MEC) study team members over the 14 days following first treatment

Exclusion criteria

Exclusion criteria: 1. Participants with a known sensitivity to any of the ingredients in Hedrin 4% lotion or Derbac-M liquid 2. Participants with a secondary bacterial infection of the scalp (e.g. impetigo) or who have a long-term scalp condition (e.g. psoriasis of the scalp) 3. Participants who have been treated with other head lice products within the previous two weeks 4. Participants who have bleached hair, or hair that has been colour treated or permanently waved within the previous four weeks (wash in/wash out colours are acceptable) 5. Participants who have been treated with the antibiotics Co-Trimoxazole, Septrin or Trimethoprim within the previous four weeks, or who are currently taking such a course 6. Pregnant or nursing mothers 7. Participants who have participated in another clinical study within one month before entry to this study 8. Participants who have already participated in this clinical study

Design outcomes

Primary

MeasureTime frame
To compare the efficacy of Hedrin 4% lotion against Derbac-M liquid in the eradication of head lice.

Secondary

MeasureTime frame
To compare Hedrin 4% lotion against Derbac-M liquid for safety, ease of use, and participant acceptability.

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Apr 6, 2026