A proof of concept clinical investigation to evaluate the activity of Hedrin® 4% lotion in the treatment of head lice using a 1-hour application time
| ISRCTN | ISRCTN95412572 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN95412572 |
| EudraCT/CTIS number | 2008-005787-13 |
| Secondary identifying numbers | CTMK08 |
- Submission date
- 11/11/2008
- Registration date
- 01/12/2008
- Last edited
- 06/07/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Plain English summary of protocol
Background and study aims
We know from previous studies that Hedrin 4% lotion is effective with an 8 hour application time and reasonably effective with a 20 minutes application. The aim of this study is to confirm that Hedrin 4% lotion works just as well to eliminate head louse infestation using it for 1 hour.
Who can participate?
The study is open to anyone who has head lice over the age of 6 months and who fits the other entry criteria.
What does the study involve?
The study first involves checking for presence of lice. If you then wish to take part we shall ask you (or your carer) to sign a consent form after which we can apply the treatment. A second application of the treatment product is applied after 7 days to eliminate any young lice that emerge from eggs during that first week. We shall check the safety and acceptability of the treatment and the progress of the effectiveness when we comb everyone looking for lice twice between treatments, on days 1 and 6 after first treatment, and then twice after the second treatment on days 9 and 14. Anyone who has lice after the second treatment will be provided with a different treatment (Hedrin 4% lotion 8 hours application) to eliminate the infestation.
What are the possible benefits and risks of participating?
We hope everyone who takes part will have their head lice eliminated
Where is the study run from?
The study will be conducted in and around the area of Cambridgeshire by the Medical Entomology Centre based just outside Cambridge. Our team of investigators will visit you at home to run all the procedures so you dont need to go anywhere.
When is the study starting and how long is it expected to run for?
The study starts in November 2008 and will run until about the end of February 2009.
Who is funding the study?
It is being funded by Thornton & Ross Ltd, the makers of Hedrin 4% lotion.
Who is the main contact?
The main contact for the study is Elizabeth Brunton at the Medical Entomology Centre.
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 |
|---|---|
| ian@insectresearch.com |
Study information
| Study design | Single-centre non-randomised single-arm proof of concept study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | A proof of concept clinical investigation to evaluate the activity of Hedrin® 4% lotion in the treatment of head lice using a 1-hour application time |
| Study objectives | To determine whether Hedrin® 4% lotion can be used for a shorter application time (1 hour) in the eradication of head lice than the currently approved overnight application, and to evaluate the treatment regimen with regard to safety, ease of application, and participant acceptability. |
| Ethics approval(s) | Essex 1 Research Ethics Committee, approved on 27/10/2008 (ref: 08/H0301/114) |
| Health condition(s) or problem(s) studied | Head louse infestation |
| Intervention | All participants will received the following intervention (single-arm trial): One-hour application of dimeticone 4% (Hedrin® 4%) lotion, on day zero (at enrolment) and day 7. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Phase IV |
| Drug / device / biological / vaccine name(s) | Dimeticone (Hedrin®) |
| Primary outcome measure | 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. Prevention of louse egg hatching (ovicidal action), defined as no 1st and 2nd stage nymphs found at assessments during the week following the first treatment 2. Safety of the product monitored by observation for adverse events on days 0, 1, 6, 7, 9, and 14 of the study 3. Ease of use by investigators, assessed by a questionnaire on the day of the first treatment 4. Participant acceptability, assessed by a questionnaire at the final assessment on day 14 |
| Overall study start date | 17/11/2008 |
| Completion date | 31/01/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Other |
| Sex | Both |
| Target number of participants | 40 |
| Key inclusion criteria | 1. Both males and females, aged 6 months and over with no upper age limit 2. Participants who upon examination, are confirmed to have live head lice 3. Participants 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. Participants who will be available for follow-up visits by study team members over the 14 days following first treatment |
| Key exclusion criteria | 1. Participants with a known sensitivity to any of the ingredients in Hedrin® 4% lotion 2. Participants 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. Participants who have been treated with other head lice products within the previous two weeks 4. Participants who have bleached hair, or hair that has been permanently waved within the previous four weeks 5. Participants 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. Participants who have participated in another clinical study within 1 month before entry to this study 8. Participants who have already participated in this clinical study |
| Date of first enrolment | 17/11/2008 |
| Date of final enrolment | 31/01/2009 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
CB25 9AU
United Kingdom
Sponsor information
Industry
Linthwaite
Huddersfield
HD7 5QH
United Kingdom
| Website | http://www.thorntonross.com |
|---|---|
"ROR" |
https://ror.org/00frd0c49 |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| 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 | To be confirmed at a later date |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
06/07/2016: Verified study information with principal investigator. Added EudraCT number, ORCID, data sharing plan
29/06/2016: No publications found, verifying study status with principal investigator
