Condition category
Infections and Infestations
Date applied
19/04/2011
Date assigned
24/05/2011
Last edited
03/02/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

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

Trial website

Contact information

Type

Scientific

Primary contact

Mr Ian F Burgess

ORCID ID

http://orcid.org/0000-0003-0747-3938

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

CTFT01

Study information

Scientific title

A single centre, single arm, non randomised study to investigate the activity of Fulltec Anti-Lice Protector in the treatment of head lice

Acronym

Study hypothesis

The 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

Cambridgeshire 1 Research Ethics Committee approved on 03/03/2011, ref: 10/H0304/95

Study design

Single-centre single-arm non-randomised proof of concept study

Primary study design

Interventional

Secondary study design

Non randomised study

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

Fulltec 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 type

Drug

Phase

Not Applicable

Drug names

Fulltec Anti-Lice Protector

Primary outcome measures

Cure 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 measures

1. 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 trial start date

26/01/2010

Overall trial end date

09/07/2011

Reason abandoned

Eligibility

Participant inclusion criteria

1. 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

30

Participant exclusion criteria

1. 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

Recruitment start date

01/04/2011

Recruitment end date

01/06/2011

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Medical Entomology Centre
Cambridge
CB25 9AU
United Kingdom

Sponsor information

Organisation

Fulltec AG (Switzerland)

Sponsor details

Chamerstrasse 14
Postfach 848
Zug
CH-6301
Switzerland
+41 (0)41 710 57 32
office@fulltec.ch

Sponsor type

Industry

Website

http://www.fulltec.ch/

Funders

Funder type

Industry

Funder name

Fulltec AG (Switzerland)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Publication deferred by sponsor after which the company broke up and restructured. Investigators plan to publish in a peer reviewed journal.

IPD Sharing plan:
The current data sharing plans for the current study are unknown and will be made available at a later date.

Intention to publish date

31/12/2017

Participant level data

To be made available at a later date

Results - basic reporting

Publication summary

Publication citations

Editorial Notes

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.