Is Liceko® more effective than Nix® / Lyclear® against head lice?
| ISRCTN | ISRCTN45553737 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN45553737 |
| Secondary identifying numbers | CTPN01 |
- Submission date
- 19/04/2011
- Registration date
- 24/05/2011
- Last edited
- 06/09/2013
- 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
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 |
|---|---|
| ian@insectresearch.com |
Study information
| Study design | Single-centre randomised two-arm comparative study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | A randomised, controlled, assessor-blind, clinical trial to compare Liceko® with Nix® / Lyclear® 1% permethrin creme rinse in the treatment of head lice. |
| Study objectives | To confirm that Liceko® is effective to kill head lice and their eggs using two applications in comparison with two applications of Nix® / 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) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Head louse infestation |
| Intervention | Group A Liceko®: 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 20 minutes before being shampooed and rinsed off with water. Group B Nix® / Lyclear® : The product will be applied to washed and towel dried hair. Sufficient product will be applied to saturate the hair and scalp. The product will be left in place for 10 minutes before being rinsed off with water. For both treatments the product will be reapplied at Day 7. |
| Intervention type | Other |
| Primary outcome measure | Cure of infestation, defined as no evidence of head lice, assessed between completion of the second application of treatment on day 7 and day 14 (the first treatment being applied on day 0). |
| Secondary outcome measures | 1. Comparison of the efficacy of Liceko® with that of Nix® / Lyclear® crème 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 study start date | 01/07/2011 |
| Completion date | 31/10/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 6 Months |
| Sex | Both |
| Target number of participants | 44 divided into two groups of 22 |
| 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. People with a known sensitivity to any of the ingredients in Liceko ® or Nix® / 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 | 01/07/2011 |
| Date of final enrolment | 31/10/2011 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Medical Entomology Centre
Cambridge
CB25 9AU
United Kingdom
CB25 9AU
United Kingdom
Sponsor information
Panin S.R.L (Italy)
Industry
Industry
Viale Della Scienza 24
Rovigo
45100
Italy
| Phone | +39 (0)42 547 1323 |
|---|---|
| f.astolfi@panin.it | |
| Website | http://www.panin.it/ |
"ROR" |
https://ror.org/00c5hbd86 |
Funders
Funder type
Industry
Panin S.R.L (Italy)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 | 03/09/2013 | Yes | No |
