Does Lyclear® spray away work better than permethrin to cure head lice?
| ISRCTN | ISRCTN96469780 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN96469780 |
| Protocol serial number | CTOM01, version 1.3 (18/02/2008) |
| Sponsor | Omega Pharma N.V. (Belgium) |
| Funder | Omega Pharma N.V. (Belgium) |
- 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 of protocol
Not provided at time of registration
Contact information
Mr Ian Burgess
Scientific
Scientific
Medical Entomology Centre
Insect Research & Development Limited
Cambridge House
Barrington Road
Shepreth
Royston
SG8 6QZ
United Kingdom
| Phone | +44 1763 263011 |
|---|---|
| ian@insectresearch.com |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised, controlled, assessor blind, parallel group study. |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | A 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 objectives | To 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) |
| Health condition(s) or problem(s) studied | Infestation with head lice (Pediculus capitis) |
| Intervention | The 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 type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Permethrin |
| Primary outcome measure(s) |
1. Number of participants with no evidence of active head louse infestation 14 days (+/- 1 day) after enrolment |
| Key secondary outcome measure(s) |
1. Ease of application (investigator opinion), assessed using a questionnaire on the same day as the first treatment |
| Completion date | 31/05/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | All |
| Target sample size at registration | 100 |
| Key inclusion criteria | 1. 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 |
| Key exclusion criteria | 1. 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 |
| Date of first enrolment | 23/03/2008 |
| Date of final enrolment | 31/05/2008 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Medical Entomology Centre
Royston
SG8 6QZ
United Kingdom
SG8 6QZ
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 | 01/01/2010 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
13/09/2017: internal review.
