Does Lyclear® spray away work better than permethrin to cure head lice?

ISRCTN ISRCTN96469780
DOI https://doi.org/10.1186/ISRCTN96469780
Secondary identifying numbers CTOM01, version 1.3 (18/02/2008)
Submission date
07/04/2008
Registration date
29/05/2008
Last edited
13/09/2017
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

Not provided at time of registration

Contact information

Mr Ian Burgess
Scientific

Medical Entomology Centre
Insect Research & Development Limited
Cambridge House
Barrington Road
Shepreth
Royston
SG8 6QZ
United Kingdom

+44 1763 263011
ian@insectresearch.com

Study information

Study designRandomised, controlled, assessor blind, parallel group study.
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleA randomised, controlled, assessor-blind, clinical trial to investigate superiority of Lyclear® spray away (ParaNix® spray) compared with Infectopedicul® permethrin 0.5% lotion in the treatment of head lice
Study hypothesisTo investigate superiority of Lyclear® spray away (ParaNix® spray) over Infectopedicul® in the eradication of head lice and prevention of hatching of louse eggs and to compare the products for safety, ease of application and participant acceptability.
Ethics approval(s)Leeds (West) Research Ethics Committee. Date of approval: 04/03/2008 (ref: 08/H1307/18)
ConditionInfestation with head lice (Pediculus capitis)
InterventionThe participants will be randomly allocated to the two groups in equal numbers.

Group 1: Participants will be treated with Lyclear® spray away (ParaNix® spray; topical) containing:
Active: Illicium verum (star anise) oil, caprylic/capric triglyceride (fractionated coconut oil derivative), cananga odorata (ylang-ylang) oil
Excipients: Propan-2-ol

Group 2: Participants will be treated with Infectopedicul® lotion (topical) containing:
Active: 0.5% permethrin
Excipients: Ethanol, propanol-2-ol, water, propylene glycol, sodium hydrogen phosphate

The total duration of intervention and follow-up for each participant is 15 days, two treatments 9 days apart with a follow-up 2 and 7 days after the first treatment and 2 and 5 days after the second treatment.
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Permethrin
Primary outcome measure1. Number of participants with no evidence of active head louse infestation 14 days (+/- 1 day) after enrolment
2. Safety, assessed 2 and 7 days after the first treatment, and 2 and 5 days after the second treatment
Secondary outcome measures1. Ease of application (investigator opinion), assessed using a questionnaire on the same day as the first treatment
2. Participant acceptability, assessed using a questionnaire 5 days after the second treatment
Overall study start date23/03/2008
Overall study end date31/05/2008

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexBoth
Target number of participants100
Participant inclusion criteria1. Both males and females, aged 2 years 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
Participant exclusion criteria1. Participants with a known sensitivity to any of the ingredients in Lyclear® spray away (ParaNix® spray) or Infectopedicul® lotion
2. Participants with asthma or a similar respiratory condition
3. 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)
4. Participants who have been treated with other head lice products within the previous two weeks
5. 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)
6. Participants who have been treated with the antibiotics co-trimoxazole or trimethoprim within the previous four weeks, or who are currently taking such a course
7. Pregnant or nursing mothers
8. Participants who have participated in another clinical study within 1 month before entry to this study
9. Participants who have already participated in this clinical study
Recruitment start date23/03/2008
Recruitment end date31/05/2008

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Medical Entomology Centre
Royston
SG8 6QZ
United Kingdom

Sponsor information

Omega Pharma N.V. (Belgium)
Industry

Venecoweg 26
Nazareth
B-9810
Belgium

http://www.omega-pharma.be
ROR logo https://ror.org/04f919z92

Funders

Funder type

Industry

Omega Pharma N.V. (Belgium)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/01/2010 Yes No

Editorial Notes

13/09/2017: internal review.

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