Condition category
Infections and Infestations
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information



Primary contact

Mr Ian Burgess


Contact details

Medical Entomology Centre
Insect Research & Development Limited
Cambridge House
Barrington Road
United Kingdom
+44 (0)1763 263011

Additional identifiers

EudraCT number number

Protocol/serial number

Protocol CTNC02, Version: 1.0, 20 February 2007

Study information

Scientific title

A randomised, assessor-blinded clinical study to compare the efficacy and safety of Nice 'n Clear with Full Marks solution and to evaluate a novel ultrasound comb device 'ClearBrush' for removal of nits



Study hypothesis

This study has two elements; in the first a comparison will be made of the silicone-based Nice 'n Clear with that of Full Marks solution. At the same time ClearBrush will be evaluated for efficacy at removing louse eggs and nits using both the new formulation of Nice 'n Clear and the original formulation.

The data obtained from the comparison of Nice 'n Clear with Full Marks solution and the data obtained in the earlier CTNC01 study will be used as baseline data for comparing the efficacy of ClearBrush to facilitate louse egg removal using each of these lubricants. Safety, ease of application, and participant acceptability of each of the products will also be assessed.

Ethics approval

Cambridgeshire 1 Research Ethics Committee, 20/06/2007, ref: 07/Q0104/44

Study design

Randomised single-blind (assessor-blind) parallel-group comparative multicentre study

Primary study design


Secondary study design

Randomised controlled trial

Trial setting


Trial type


Patient information sheet


Head louse infestation (pediculosis capitis)


1. Herbal-based (neem oil, with tea tree, thyme and lemongrass essential oils) lotion in a silicone vehicle (reformulated Nice 'n Clear lotion) (66 participants)
2. Isopropyl myristate/cyclomethicone lotion (Full Marks solution) (66 participants)
3. ClearBrush ultrasound nit-removing comb in combination with herbal-based lotion in an aqueous cream vehicle (original Nice 'n Clear head louse treatment lotion) (22 participants)
4. ClearBrush ultrasound nit-removing comb in combination with herbal-based lotion in a silicone vehicle (reformulated Nice 'n Clear lotion) (22 participants)

The total time for intervention and follow-up for each participant is 15 days, two treatments a week apart with a follow-up 2 and 6 days after the first treatment and 2 and 7 days after the second treatment.

Intervention type



Not Applicable

Drug names

Herbal-based (neem oil, with tea tree, thyme and lemongrass essential oils) lotion in a silicone vehicle (reformulated Nice 'n Clear lotion)

Primary outcome measures

1. To evaluate the efficacy of using reformulated Nice 'n Clear lotion in comparison with Full Marks solution to cure an infection, i.e. no lice at the days 9 and 14 assessments
2. To evaluate the efficacy of the ClearBrush in use with the new and the original Nice 'n Clear head lice treatment preparations, measured using data obtained from each treatment, i.e. on days 7 and 14

Secondary outcome measures

To compare the safety and acceptability of the Nice ‘n Clear preparations and Full Marks solution, measured at the end of the 15 days

Overall trial start date


Overall trial end date


Reason abandoned


Participant inclusion criteria

1. Male and female participants who are found to have an active head louse infection, i.e. the presence of live lice. Detection combing will be done with a fine-toothed plastic detection comb, until at least one louse is found. Any lice found at these assessments will not be removed.
2. Participants who give written informed consent and/or, if the participant is below 16 years of age, whose guardian gives written informed consent to participate in the study. An assent form will be required for those between the ages of 4 and 16 years of age. There is no maximum age limit. The lower age limit for this study will be 2 years (Nice 'n Clear is marketed as a medical device for babies and children down to the age of 6 months and Full Marks solution for children down to 2 years).
3. Participants must be available for the duration of the study, i.e. 15 days

Participant type


Age group




Target number of participants


Participant exclusion criteria

1. Participants who have been treated with other head louse products within the previous 2 weeks (14 days)
2. Participants who have undergone a course of antibiotic treatment using Cotrimoxazole, Trimethoprim or Septrin within the previous 4 weeks, or who are currently taking such a course
3. Participants whose hair has been bleached, colour treated, or semi-permanently waved within the previous 2 weeks; this includes the use of semi-permanent colouring agents. Home use wash in/wash out colouring agents are acceptable.
4. Participants who have taken part in another clinical study within 4 weeks prior to entry to this one
5. Female participants who are pregnant or breastfeeding
6. Participants who have already taken part in this study
7. Participants who have a known allergy to any of the ingredients of either of the Nice 'n Clear preparations or Full Marks solution (including allergy to Paraben preservatives)
8. Children under 2 years of age

Recruitment start date


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

Medical Entomology Centre
United Kingdom

Sponsor information


Nelsons (UK)

Sponsor details

Nelsons House
83 Parkside
SW19 5LP
United Kingdom

Sponsor type




Funder type


Funder name

European Commission (Belgium) - 6th Framework Programme: horizontal research activities involving SMES co-operative research (contract number: 017916-ClearBrush)

Alternative name(s)

Funding Body Type

Funding Body Subtype


Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes