Kindaped™ lotion for treatment of head lice
| ISRCTN | ISRCTN28722846 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN28722846 |
| Secondary identifying numbers | CTMK12 |
- Submission date
- 27/09/2010
- Registration date
- 11/10/2010
- Last edited
- 13/08/2012
- 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
Insect Research & Development Limited
6 Quy Court
Colliers Lane
Stow-cum-Quy
Cambridge
CB25 9AU
United Kingdom
| Phone | +44 (0)1223 810 070 |
|---|---|
| ian@insectresearch.com |
Study information
| Study design | Two-centre randomised three-arm comparative study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| 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 randomised, assessor blinded, clinical trial to confirm the efficacy of a CE marked class I medical device formulation in the treatment of head lice |
| Study objectives | A randomised, assessor blind clinical investigation designed to confirm efficacy in use and obtain further information about routine usage of two variants of the same CE marked class I medical device product based on 1,2-octanediol in the control and elimination of head louse infestation. |
| Ethics approval(s) | Leeds (West) Research Ethics Committee approved (provisionally) on the 20th September 2010 (ref: 10/H1307/106) |
| Health condition(s) or problem(s) studied | Head louse infestation |
| Intervention | Group A: KindaPed AF (5% 1,2-octanediol alcohol free lotion), applied for 2 hours (maximum 2.5 hours) before washing off using shampoo, with a repeat treatment one week later. Group B: KindaPed AF (5% 1,2-octanediol alcohol free lotion), applied for 8 hours (minimum) or overnight before washing off using shampoo, with a repeat treatment one week later. Group C: KindaPed lotion (5% 1,2-octanediol lotion with 20% alcohol), applied for 2 hours (maximum 2.5 hours) before washing off using shampoo, with a repeat treatment one week later. |
| Intervention type | Other |
| 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 or after the second application of 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 | 10/10/2010 |
| Completion date | 31/12/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 6 Months |
| Sex | Both |
| Target number of participants | 120 divided into three groups of 40 |
| Key inclusion criteria | 1. Both males and females, aged 6 months 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 14 days following first treatment |
| Key exclusion criteria | 1. People with a known sensitivity to any of the ingredients in KindaPed AF (5% 1,2-octanediol alcohol free lotion) or in KindaPed lotion (5% 1,2-octanediol lotion with 20% alcohol) 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 bleached hair, or hair that has been permanently waved within the previous four weeks 5. 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 6. Pregnant or nursing mothers 7. People who have participated in another clinical study within 1 month before entry to this study 8. People who have already participated in this clinical study |
| Date of first enrolment | 10/10/2010 |
| Date of final enrolment | 31/12/2010 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Medical Entomology Centre
Cambridge
CB25 9AU
United Kingdom
CB25 9AU
United Kingdom
Sponsor information
Thornton & Ross Ltd (UK)
Industry
Industry
c/o Steve Skilleter
Linthwaite
Huddersfield
HD7 5QH
United Kingdom
| Phone | +44 (0)1484 842 217 |
|---|---|
| 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 | 01/04/2012 | Yes | No |
