A phase IIa clinical trial to demonstrate proof of concept of an experimental pediculicide lotion for the treatment of head lice
| ISRCTN | ISRCTN66611560 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN66611560 |
| Secondary identifying numbers | CT:EP01 |
- Submission date
- 02/06/2006
- Registration date
- 20/07/2006
- 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
Mrs Christine Brown
Scientific
Scientific
The Medical Entomology Centre
Cambridge House
Barrington Road
Shepreth
Royston
SG8 6QZ
United Kingdom
| Phone | +44 (0)1763 263011 |
|---|---|
| christine@insectresearch.com |
Study information
| Study design | Open label, non-controlled proof of concept study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Cohort study |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | |
| Study acronym | KindaPed |
| Study objectives | The primary aims of this trial are to assess the efficacy and safety of KindaPed™ to eradicate head lice infection. The secondary aims are to assess the ease of application of the product and to show the amount of lotion used for each participant and thus enable the sponsor to establish the average amount of product required for treatment. |
| Ethics approval(s) | Approval by Hertfordshire Research Ethics Committee 2 (REC 2) on 25/05/2006, reference number is 06/Q0204/15 |
| Health condition(s) or problem(s) studied | Head lice infestation |
| Intervention | 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). |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Phase II |
| Drug / device / biological / vaccine name(s) | KindaPed |
| Primary outcome measure | 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 measures | 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 |
| Overall study start date | 08/06/2006 |
| Completion date | 30/09/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 20 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 08/06/2006 |
| Date of final enrolment | 30/09/2006 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
The Medical Entomology Centre
Royston
SG8 6QZ
United Kingdom
SG8 6QZ
United Kingdom
Sponsor information
EctoPharma Limited (UK)
Industry
Industry
54 Queen Street
Edinburgh
EH2 3NS
United Kingdom
| Phone | +44 (0)131 225 5132 |
|---|---|
| magnusnicolson@aol.com |
Funders
Funder type
Industry
EctoPharma Limited
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 | 01/09/2012 | Yes | No |
