A randomised, controlled, assessor-blind, clinical trial to demonstrate superiority of Hedrin 4% dimeticone lotion compared with Derbac-M 0.5% malathion aqueous liquid in the treatment of head lice
| ISRCTN | ISRCTN47755726 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN47755726 |
| EudraCT/CTIS number | 2006-004136-73 |
| Secondary identifying numbers | CTMK05 |
- Submission date
- 05/12/2006
- Registration date
- 27/12/2006
- Last edited
- 11/11/2008
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Mr Ian Burgess
Scientific
Scientific
Medical Entomology Centre
Cambridge House
Barrington Road
Shepreth
Royston
SG8 6QZ
United Kingdom
| Phone | +44 (0)1763 263011 |
|---|---|
| ian@insectresearch.com |
Study information
| Study design | A randomised, controlled, assessor-blind, parallel group clinical trial. |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Scientific title | |
| Study objectives | Is Hedrin 4% lotion more effective than Derbac-M liquid in the treatment of head louse infestation? |
| Ethics approval(s) | Hertfordshire 1 Research Ethics Committee reviewed 14 August 2006 (ref.: 06/Q0201/52). |
| Health condition(s) or problem(s) studied | Head louse infestation |
| Intervention | Dimeticone 4% lotion (Hedrin 4% lotion): The product 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. The product will be reapplied at day seven. Malathion 0.5% aqueous emulsion (Derbac-M liquid): The product 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. The product will be reapplied at day seven. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Hedrin and Derbac-M |
| Primary outcome measure | To compare the efficacy of Hedrin 4% lotion against Derbac-M liquid in the eradication of head lice. |
| Secondary outcome measures | To compare Hedrin 4% lotion against Derbac-M liquid for safety, ease of use, and participant acceptability. |
| Overall study start date | 01/10/2006 |
| Completion date | 31/12/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Other |
| Sex | Not Specified |
| Target number of participants | 58 children and 15 adults |
| Key inclusion criteria | 1. Participants aged six 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 home visits by Medical Entomology Centre (MEC) 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 Derbac-M liquid 2. Participants with a secondary bacterial infection of the scalp (e.g. impetigo) or who have a 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 colour treated or permanently waved within the previous four weeks (wash in/wash out colours are acceptable) 5. Participants who have been treated with the antibiotics Co-Trimoxazole, Septrin 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 one month before entry to this study 8. Participants who have already participated in this clinical study |
| Date of first enrolment | 01/10/2006 |
| Date of final enrolment | 31/12/2006 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Medical Entomology Centre
Royston
SG8 6QZ
United Kingdom
SG8 6QZ
United Kingdom
Sponsor information
Thornton & Ross Ltd (UK)
Industry
Industry
Linthwaite
Huddersfield
HD7 5QH
United Kingdom
| Phone | +44 (0)1484 842217 |
|---|---|
| steveskilleter@thorntonross.com | |
| Website | http://www.thorntonross.com/ |
"ROR" |
https://ror.org/00frd0c49 |
Funders
Funder type
Industry
Thornton & Ross Ltd (UK)
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 | 07/11/2007 | Yes | No |
