An investigation of the activity of Fulltec Anti-Lice Protector in the treatment of head lice

ISRCTN ISRCTN79136319
DOI https://doi.org/10.1186/ISRCTN79136319
Secondary identifying numbers CTFT01
Submission date
19/04/2011
Registration date
24/05/2011
Last edited
12/02/2021
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

Background and study aims:
Head lice are tiny insects that live in hair. They are a common problem, particularly among school-age children. Head lice are spread by direct head to head contact. Although they are harmless, the bites of these lice can cause itching and can be very frustrating for sufferers. Fulltec Anti-Lice Protector is a shampoo based on vegetable oils that is claimed to kill lice by blocking spiracles, usually applied for 15-30 minutes. The aim of this study is to test the effectiveness of Fulltec Anti-Lice Protector in the treatment of head lice using a shortened application time

Who can participate?
People aged 2 years and over who have head lice.

What does the study involve?
Each consenting participant with confirmed louse infestation is treated by applying the Fulltec Anti-Lice Protector to pre-washed and towel dried hair and left for 15 minutes, rinsed and dried to check that this application time is long enough to be effective. This procedure is repeated after 8 days. The prescence of headlice are then looked for by combing to look for lice on days 1, 8, and 16 after the initial treatment.

What are the possible benefits and risks?
If the treatment regimen is successful participants benefit from getting rid of their head lice completely. There is a small risk that some participants may experience irritation of the scalp from the shampoo or dryness of the skin afterwards.

Where is the study run from?
Medical Entomology Centre, Cambridge (UK)

When is study starting and how long is it expected to run for?
January 2010 to July 2011

Who is funding the study?
Fulltec AG, Zug, (Switzerland)

Who is the main contact?
Mr Ian F Burgess
ian@insectresearch.com

Contact information

Mr Ian F Burgess
Scientific

Medical Entomology Centre
Insect Research & Development Limited
6 Quy Court
Colliers Lane
Stow-cum-Quy
Cambridge
CB25 9AU
United Kingdom

ORCiD logoORCID ID 0000-0003-0747-3938
Phone +44 (0)122 381 0070
Email ian@insectresearch.com

Study information

Study designSingle-centre single-arm non-randomised proof of concept study
Primary study designInterventional
Secondary study designNon randomised study
Study setting(s)Other
Study typeTreatment
Participant information sheet ISRCTN79136319_PIS_13Jan11_V1_Parents.pdf
Scientific titleA single centre, single arm, non randomised study to investigate the activity of Fulltec Anti-Lice Protector in the treatment of head lice
Study objectivesThe aim of this study is to provide evidence of the activity of Fulltec Anti-Lice Protector in the treatment of head louse infection using a shortened application time (15 minutes).
Ethics approval(s)Cambridgeshire 1 Research Ethics Committee approved on 03/03/2011, ref: 10/H0304/95
Health condition(s) or problem(s) studiedHead louse infestation
InterventionFulltec Anti-Lice Protector shampoo applied to pre-washed and towel dried hair for 15 minutes followed by rinsing, with a repeat treatment 8 days later.
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Applicable
Drug / device / biological / vaccine name(s)Fulltec Anti-Lice Protector
Primary outcome measureCure of infestation, defined as no evidence of head lice, assessed between completion of the second application of treatment on day 8 and day 16 (the first treatment being applied on day 0).
Secondary outcome measures1. Safety of the product monitored by observation for adverse events on days 0, 1, 8, and 16 of the study
2. Acceptability of the product, assessed by a questionnaire at day 1
Overall study start date26/01/2010
Completion date09/07/2011

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants30
Total final enrolment31
Key inclusion criteria1. Both males and females, aged 2 years 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 16 days following first treatment
Key exclusion criteria1. People with a known sensitivity to nuts, coconut, or any of the ingredients in Fulltec Anti-Lice Protector
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 been treated with the antibiotics co-trimoxazole or trimethoprim within the previous four weeks, or who are currently taking such a course
5. Pregnant or nursing mothers
6. People who have participated in another clinical study within one month before entry to this study
7. People who have already participated in this clinical study
Date of first enrolment01/04/2011
Date of final enrolment01/06/2011

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Medical Entomology Centre
Cambridge
CB25 9AU
United Kingdom

Sponsor information

Fulltec AG (Switzerland)
Industry

Chamerstrasse 14
Postfach 848
Zug
CH-6301
Switzerland

Phone +41 (0)41 710 57 32
Email office@fulltec.ch
Website http://www.fulltec.ch/
ROR logo "ROR" https://ror.org/02g1dfh62

Funders

Funder type

Industry

Fulltec AG (Switzerland)

No information available

Results and Publications

Intention to publish date31/12/2017
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryData sharing statement to be made available at a later date
Publication and dissemination planPublication deferred by sponsor after which the company broke up and restructured. Investigators plan to publish in a peer reviewed journal.
IPD sharing planThe current data sharing plans for the current study are unknown and will be made available at a later date.

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Participant information sheet version V1 13/01/2011 03/02/2017 No Yes
Participant information sheet version V1 17/01/2011 03/02/2017 No Yes
Results article results 02/12/2020 12/02/2021 Yes No

Additional files

ISRCTN79136319_PIS_13Jan11_V1_Parents.pdf
Uploaded 03/02/2017
ISRCTN79136319_PIS_17Jan11_V1_Children.pub
Uploaded 03/02/2017

Editorial Notes

12/02/2021: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.
03/02/2017: The following changes have been made to the record:
1. The overall trial dates have been updated from 01/04/2011 - 01/06/2011 to 26/01/2010 - 09/07/2011
2. The ORCID ID, IPD Sharing plan, publication and dissemination plan and plain English summary have been added
3. The participant information sheet has been uploaded
02/02/2017: No publications found in PubMed, verifying study status with principal investigator.