A phase IIa clinical trial to demonstrate proof of concept of an experimental pediculicide lotion for the treatment of head lice

• Register: ISRCTN
• Last refreshed on: 12 February 2013
• Main ID: ISRCTN66611560
• Date of registration: 20/07/2006
• Primary sponsor: EctoPharma Limited (UK)
• Public title: A phase IIa clinical trial to demonstrate proof of concept of an experimental pediculicide lotion for the treatment of head lice KindaPed
• Date of first enrolment: Jun 8 2006
• Target sample size: 20
• Recruitment status: Completed/Not recruiting
• URL: http://isrctn.org/ISRCTN66611560
• Study type: Interventional
• Study design: Open label, non-controlled proof of concept study

Countries of recruitment

United Kingdom

Contacts

• Name: Christine Brown

Key inclusion & exclusion criteria

Inclusion criteria: 1. Patients aged four and over
2. Patients who upon examination, are confirmed to have live head lice
3. Patients who give their written informed consent, or if the patient is less than 16 years of age, whose parent/guardian gives written informed consent to participate in the study
4. Patients who will be available for home visits from Medical Entomology Centre (MEC) study team members over the 15 days of the study
Exclusion criteria: 1. Patients with a known sensitivity to any of the ingredients in the product
2. Patients 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. Patients known to suffer from asthma
4. Patients who have been treated with other head lice products within the last two weeks. There must be a 14-day gap since treatment for head lice was last used before the patient can be accepted on to this trial.
5. Patients who have bleached hair, or hair that has been colour treated or permanently waved within the last four weeks (wash in/wash out colours are acceptable)
6. Patients who have been treated with the antibiotics co-trimoxazole, septrin or trimethoprim within the last four weeks, or who are currently taking such a course
7. Pregnant or nursing mothers
8. Patients who have participated in another clinical study within one month before entry to this study
9. Patients who have already participated in this clinical study

Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Head lice infestation

Intervention(s)

The product will be applied directly to dry hair. Sufficient product will be applied to thoroughly moisten the hair and scalp. The product will be left in place overnight before being shampooed and rinsed off with water the next morning. The product will be reapplied at day 7(+/-1 day).

Primary Outcome(s)

1. To assess the efficacy of KindaPed™ to cure head lice infection
2. To assess the efficacy of KindaPed™ to kill head lice
3. To evaluate the efficacy of KindaPed™ to kill louse eggs
4. To monitor the safety and acceptability of KindaPed™ in clinical use

Secondary Outcome(s)

1. To assess the ease of application of KindaPed™
2. To assess the total treatment dose for each participant, and to calculate an average dose level for this product

Secondary ID(s)

CT:EP01

Source(s) of Monetary Support

EctoPharma Limited

Secondary Sponsor(s)

N/A