Is Hedrin® 4% lotion Dev 42 more effective than Hedrin® 4% lotion against head louse eggs?
| ISRCTN | ISRCTN10431107 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10431107 |
| Secondary identifying numbers | CTMK06 |
- Submission date
- 09/03/2009
- Registration date
- 19/03/2009
- Last edited
- 30/03/2020
- 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 gets rid of a head louse infestation. The aim of this study is to compare Hedrin 4% lotion with a modified version of the product to see if the alternative is more effective to cure head louse infestation.
Who can participate?
The study will be conducted in two schools but is open to anyone in the villages serving those schools who has head lice and is 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, 2 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 further treatment (Hedrin 4% lotion) 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 the schools of Maldan and Osmancali, two villages in Manisa province, Turkey. Our team of investigators will first visit the schools to identify students with lice and then visit them at home to run all the procedures.
When is the study starting and how long is it expected to run for?
The study was carried out in April and May of 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 Dr Özgür Kurt of Celal Bayar University School of Medicine.
Contact information
Scientific
Medical Entomology Centre
Insect Research & Development Limited
6 Quy Court
Colliers Lane
Stow-cum-Quy
Cambridge
CB25 9AU
United Kingdom
| Phone | +44 (0)1223 810070 |
|---|---|
| ian@insectresearch.com |
Study information
| Study design | Randomised controlled assessor blinded parallel group study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Only available to recruiting centres/participants |
| Scientific title | A randomised, controlled, assessor-blind, clinical trial to compare Hedrin® 4% dimeticone lotion with Hedrin® 4% lotion Dev 42 in the treatment of head lice |
| Study objectives | To compare efficacy of Hedrin® 4% lotion with Hedrin® 4% lotion Dev 42 in the eradication of head lice, to compare the products for ovicidal activity, and to compare the products for safety, ease of application and participant acceptability. |
| Ethics approval(s) | Research Ethics Committee of the Medical Faculty, Celal Bayar University gave approval on the 25th February 2008 (ref: 25) |
| Health condition(s) or problem(s) studied | Head louse infestation |
| Intervention | 1. Dimeticone 4% lotion (Hedrin® 4% lotion) 2. Dimeticone 4% lotion, alternative mixture (Hedrin® 4% lotion Dev 42) Both products will be applied directly to dry hair. Sufficient product will be applied to saturate the hair and scalp. The product will be left in place for eight hours (or overnight) before being shampooed and rinsed off with water. Treatments were applied on days 0 and 7 and post-treatment assessments were conducted on days 1, 2, 6, 9, 14. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Phase III |
| Drug / device / biological / vaccine name(s) | Hedrin® 4% lotion Dev 42, Hedrin® 4% lotion |
| Primary outcome measure | 1. To compare Hedrin® 4% lotion with Hedrin® 4% lotion Dev 42 with regard to inhibition of hatching of louse eggs (ovicidal activity): no nymphal lice emerging from eggs between treatments (i.e. on day 1, 2, or 6) or after the second treatment 2. To compare the efficacy of Hedrin® 4% lotion with Hedrin® 4% lotion Dev 42 with regard to the eradication of head lice: assessed post-second treatment, i.e. no lice on days 9 or 14 |
| Secondary outcome measures | To compare Hedrin® 4% lotion with Hedrin® 4% lotion Dev 42 with regard to safety, ease of application and participant acceptability, assessments made on days 0 and 7 post-treatment application and at each of the efficacy assessments on days 1, 2, 6, 9, and 14 |
| Overall study start date | 01/04/2008 |
| Completion date | 31/05/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Other |
| Sex | Both |
| Target number of participants | 68 |
| Total final enrolment | 72 |
| Key inclusion criteria | 1. Both males and females, aged 4 years 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 or Hedrin® 4% lotion Dev 42 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 | 01/04/2008 |
| Date of final enrolment | 31/05/2008 |
Locations
Countries of recruitment
- England
- Türkiye
- 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 | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/12/2009 | 30/03/2020 | Yes | No |
Editorial Notes
30/03/2020: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.
