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
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
Scientific
Medical Entomology Centre
Insect Research & Development Limited
6 Quy Court
Colliers Lane
Stow-cum-Quy
Cambridge
CB25 9AU
United Kingdom
 ORCID ID |
0000-0003-0747-3938 |
|---|---|
| Phone | +44 (0)122 381 0070 |
| ian@insectresearch.com |
Study information
| Study design | Single-centre single-arm non-randomised proof of concept study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | ISRCTN79136319_PIS_13Jan11_V1_Parents.pdf |
| 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 |
| Study objectives | 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(s) | Cambridgeshire 1 Research Ethics Committee approved on 03/03/2011, ref: 10/H0304/95 |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Fulltec Anti-Lice Protector |
| Primary outcome measure | 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 study start date | 26/01/2010 |
| Completion date | 09/07/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 30 |
| Total final enrolment | 31 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/04/2011 |
| Date of final enrolment | 01/06/2011 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
CB25 9AU
United Kingdom
Sponsor information
Industry
Chamerstrasse 14
Postfach 848
Zug
CH-6301
Switzerland
| Phone | +41 (0)41 710 57 32 |
|---|---|
| office@fulltec.ch | |
| Website | http://www.fulltec.ch/ |
"ROR" |
https://ror.org/02g1dfh62 |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 31/12/2017 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| 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. |
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.
