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
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
Additional files
- ISRCTN79136319_PIS_13Jan11_V1_Parents.pdf Uploaded 03/02/2017
- ISRCTN79136319_PIS_17Jan11_V1_Children.pub Uploaded 03/02/2017