Hedrin® Once vs Lyclear® against head lice

ISRCTN	ISRCTN88144046
DOI	https://doi.org/10.1186/ISRCTN88144046
Protocol serial number	CTMK13
Sponsor	Thornton & Ross Ltd (UK)
Funder	Thornton & Ross Ltd (UK)

Submission date: 19/04/2011
Registration date: 24/05/2011
Last edited: 27/08/2013

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Infections and Infestations

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Mr Ian F Burgess
Scientific

Medical Entomology Centre
Insect Research & Development Limited
6 Quy Court
Colliers Lane
Stow-cum-Quy
Cambridge
CB25 9AU
United Kingdom

Phone	+44 (0)122 381 0070
Email	ian@insectresearch.com

Study information

Primary study design	Interventional
Study design	Single-centre randomised two-arm comparative study
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
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
Study objectives	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(s)	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
Health condition(s) or problem(s) studied	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 / device / biological / vaccine name(s)	Hedrin® Once liquid gel, Lyclear® 1%
Primary outcome measure(s)	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).
Key secondary outcome measure(s)	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
Completion date	31/10/2011

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	84
Key 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
Key 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
Date of first enrolment	01/06/2011
Date of final enrolment	31/10/2011

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Medical Entomology Centre

Cambridge
CB25 9AU
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/04/2013		Yes	No
HRA research summary			28/06/2023	No	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes