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
CTPN01
Study information
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.
Acronym
Study hypothesis
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
Not provided at time of registration
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 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
Phase
Not Applicable
Drug names
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 trial start date
01/07/2011
Overall trial end date
31/10/2011
Reason abandoned (if study stopped)
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
Child
Gender
Both
Target number of participants
44 divided into two groups of 22
Participant 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
Recruitment start date
01/07/2011
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
Panin S.R.L (Italy)
Sponsor details
Viale Della Scienza 24
Rovigo
45100
Italy
+39 (0)42 547 1323
f.astolfi@panin.it
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
Panin S.R.L (Italy)
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
Basic results (scientific)
Publication list
2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/24004959
Publication citations
-
Results
Burgess IF, Burgess NA, Brunton ER, Tocopheryl acetate 20% spray for elimination of head louse infestation: a randomised controlled trial comparing with 1% permethrin creme rinse., BMC Pharmacol Toxicol, 2013, 14, 43, doi: 10.1186/2050-6511-14-43.