Kindaped™ lotion for treatment of head lice

ISRCTN	ISRCTN28722846
DOI	https://doi.org/10.1186/ISRCTN28722846
Protocol serial number	CTMK12
Sponsor	Thornton & Ross Ltd (UK)
Funder	Thornton & Ross Ltd (UK)

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

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
Email	ian@insectresearch.com

Study information

Primary study design	Interventional
Study design	Two-centre randomised three-arm comparative study
Secondary study design	Randomised controlled trial
Study type	Participant 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(s)	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).
Key secondary outcome measure(s)	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
Completion date	31/12/2010

Eligibility

Participant type(s)	Patient
Age group	Child
Lower age limit	6 Months
Sex	All
Target sample size at registration	120
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

United Kingdom
England

Study participating centre

Medical Entomology Centre

Cambridge
CB25 9AU
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	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
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes