Neem Lotion With Combing for Lice

NCT02974088 | Completed Phase 2 Results

• 1 other identifier: CTNC01
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

Brief Summary

This was a Phase IIa randomised, assessor blinded, parallel group study in which half the participants were treated with Nice 'n Clear neem-based conditioning lotion plus combing with a head louse detection and removal comb and the remainder were treated with Nice 'n Clear plus combing with a normal grooming comb

Conditions

Pediculoses; Head Lice

Outcome Measures

Primary Outcomes (1)

• Number of Participants Free From Head Louse Infestation as Assessed by Detection Combing

  Recruitment at Day 0. Success of treatment = No lice present at Day 14 and no lice present at Day 10

  15 days

Secondary Outcomes (2)

• Difference in Number of Participants Free From Head Louse Infestation According to Comb Type Used

  15 days

• Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0

  15 days

Study Arms (2)

Neem-based lotion plus louse comb

EXPERIMENTAL

Neem-based conditioning lotion plus head louse detection and removal comb

Device: Neem-based lotion plus louse comb

Neem-based lotion plus grooming comb

EXPERIMENTAL

Neem-based conditioning lotion plus regular grooming comb

Device: Neem-based lotion plus grooming comb

Interventions

Neem-based lotion plus louse comb DEVICE

Neem-based conditioning lotion was applied to washed and towel dried hair followed by systematic combing using a head louse detection and removal comb

Also known as: Nice 'n Clear

Neem-based lotion plus louse comb

Neem-based lotion plus grooming comb DEVICE

Neem-based conditioning lotion was applied to washed and towel dried hair followed by combing through using a regular grooming comb

Also known as: Nice 'n Clear

Neem-based lotion plus grooming comb

Eligibility Criteria

• Age: 6 Months+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Males and females 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.
• People 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. Assent/verbal assent forms will be required for those between the ages of 4 and 16 years of age. There is no maximum age limit.
• Participants must be available for the duration of the study i.e. 15 days.

You may not qualify if:

• People who have been treated with other head louse products within the previous 2 weeks (14 days).
• People 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.
• People 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.
• People who have taken part in another clinical study within 4 weeks prior to entry to this one.
• Females who are pregnant or breast-feeding.
• Participants who have already taken part in this study.
• People who have a known allergy to any of the ingredients of Nice 'n Clear Lotion (including allergy to Paraben preservatives)
• Children under 6 months of age.

Sponsors & Collaborators

• Medical Entomology Centre: lead
• Leeds Health Protection Unit: collaborator
• PN Lee Statistics and Computing Ltd: collaborator
• Nelsons: collaborator

Study Sites (1)

Medical Entomology Centre

Cambridge, CB25 9AU, United Kingdom

Location

Related Links

• Final Report Summary - ClearBrush (A Novel Integrated Ultrasonic Brush and Sonically Activated Lotion to Provide a Full System Approach to the Eradication of the European Head Louse Menace)

MeSH Terms

Conditions

Lice Infestations

Condition Hierarchy (Ancestors)

Ectoparasitic Infestations; Skin Diseases, Parasitic; Parasitic Diseases; Infections; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Ian Burgess
• Organization: Medical Entomology Centre

ian@insectresearch.com

+44 1223 810070

Study Officials

• Ian F Burgess

  Medical Entomology Centre

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: November 21, 2016
• First Posted: November 28, 2016
• Study Start: May 1, 2006
• Primary Completion: August 1, 2006
• Study Completion: August 1, 2006
• Last Updated: March 19, 2024
• Results First Posted: March 14, 2019

Record last verified: 2024-03

Locations

GB (1)