Condition category
Infections and Infestations
Date applied
19/04/2011
Date assigned
24/05/2011
Last edited
27/08/2013
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mr Ian F Burgess

ORCID ID

Contact details

Medical Entomology Centre
Insect Research & Development Limited
6 Quy Court
Colliers Lane
Stow-cum-Quy
Cambridge
CB25 9AU
United Kingdom
+44 (0)122 381 0070
ian@insectresearch.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

CTMK13

Study information

Scientific title

A randomised, controlled, assessor-blind, clinical trial to demonstrate superiority of Hedrin® Once liquid gel compared with Lyclear®1% permethrin creme rinse in the treatment of head lice

Acronym

Study hypothesis

To confirm that Hedrin® Once is effective to kill head lice and their eggs with a single application, in comparison with two applications of Lyclear® and to identify any significant difference in performance (superiority) of one product over the other in the eradication of head lice.

Ethics approval

Central London Research Ethics Committee 2 to be reviewed on the 04/05/2011 (ref: 11/LO/0455) - Approval pending as of 19/04/2011

Study design

Single-centre randomised two-arm comparative study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Head louse infestation

Intervention

Group A: Hedrin® Once liquid gel , applied for 15 minutes before washing off using shampoo, applied one one occasion only.

Group B: Lyclear® 1% permethrin creme rinse, applied for 10 minutes to pre-washed and towel dried hair before rinsing off with water, with a repeat treatment one week later.

Intervention type

Drug

Phase

Not Applicable

Drug names

Hedrin® Once liquid gel, Lyclear® 1%

Primary outcome measures

1. To demonstrate cure of infestation, defined as no evidence of head lice.
1.1. For Hedrin® Once following a single 15 minute application up to day 14
1.2. For Lyclear® creme rinse using two applications assessed between completion of the second application of treatment on day 7 and day 14 (the first treatment for both products being applied on day 0).

Secondary outcome measures

1. To compare the efficacy of Hedrin® Once with Lyclear® creme rinse and to identify superiority of one product over the other if appropriate.
2. Safety of the products monitored by observation for adverse events on days 0, 1, 6, 7, 9, and 14 of the study

Overall trial start date

01/06/2011

Overall trial end date

31/10/2011

Reason abandoned

Eligibility

Participant inclusion criteria

1. Both males and females, aged 6 months and over with no upper age limit
2. People who upon examination, are confirmed to have live head lice
3. People 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. People who will be available for follow-up visits by study team members over the 14 days following first treatment

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

84 (randomised by household) from an estimated 44 households, divided into two groups of 42

Participant exclusion criteria

1. Participants with a known sensitivity to any of the ingredients in Hedrin® Once liquid gel or Lyclear® 1% permethrin creme rinse, pyrethroid insecticides, or plants related to dandelions or chrysanthemums.
2. People with a secondary bacterial infection of the scalp (e.g. impetigo) or who have an active long-term scalp condition (e.g. psoriasis of the scalp)
3. People who have been treated with other head lice products within the previous two weeks
4. People who have bleached hair, or hair that has been permanently waved within the previous four weeks
5. People who have been treated with the antibiotics co-trimoxazole or trimethoprim within the previous four weeks, or who are currently taking such a course
6. Pregnant or nursing mothers
7. People who have participated in another clinical study within one month before entry to this study
8. People who have already participated in this clinical study

Recruitment start date

01/06/2011

Recruitment end date

31/10/2011

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Medical Entomology Centre
Cambridge
CB25 9AU
United Kingdom

Sponsor information

Organisation

Thornton & Ross Ltd (UK)

Sponsor details

Linthwaite Laboratories
Linthwaite
Huddersfield
HD7 5QH
United Kingdom
+44 (0)148 484 2217
ashleybrierley@thorntonross.com

Sponsor type

Industry

Website

http://www.thorntonross.com

Funders

Funder type

Industry

Funder name

Thornton & Ross Ltd (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2013 results in http://www.ncbi.nlm.nih.gov/pubmed/23548062

Publication citations

  1. Results

    Burgess IF, Brunton ER, Burgess NA, Single application of 4% dimeticone liquid gel versus two applications of 1% permethrin creme rinse for treatment of head louse infestation: a randomised controlled trial., BMC Dermatol., 2013, 13, 5, doi: 10.1186/1471-5945-13-5.

Additional files

Editorial Notes