Condition category
Infections and Infestations
Date applied
19/04/2011
Date assigned
24/05/2011
Last edited
06/09/2013
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

http://www.panin.it/

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

Results - basic reporting

Publication summary

2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/24004959

Publication citations

  1. 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.

Additional files

Editorial Notes