Hedrin® Once vs Lyclear® against head lice
| ISRCTN | ISRCTN88144046 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN88144046 |
| Secondary identifying numbers | CTMK13 |
- Submission date
- 19/04/2011
- Registration date
- 24/05/2011
- Last edited
- 27/08/2013
- 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
Not provided at time of registration
Contact information
Mr Ian F Burgess
Scientific
Scientific
Medical Entomology Centre
Insect Research & Development Limited
6 Quy Court
Colliers Lane
Stow-cum-Quy
Cambridge
CB25 9AU
United Kingdom
| Phone | +44 (0)122 381 0070 |
|---|---|
| ian@insectresearch.com |
Study information
| Study design | Single-centre randomised two-arm comparative study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | A randomised, controlled, assessor-blind, clinical trial to demonstrate superiority of Hedrin® Once liquid gel compared with Lyclear®1% permethrin creme rinse in the treatment of head lice |
| Study hypothesis | To confirm that Hedrin® Once is effective to kill head lice and their eggs with a single application, in comparison with two applications of Lyclear® and to identify any significant difference in performance (superiority) of one product over the other in the eradication of head lice. |
| Ethics approval(s) | Central London Research Ethics Committee 2 to be reviewed on the 04/05/2011 (ref: 11/LO/0455) - Approval pending as of 19/04/2011 |
| Condition | Head louse infestation |
| Intervention | Group A: Hedrin® Once liquid gel , applied for 15 minutes before washing off using shampoo, applied one one occasion only. Group B: Lyclear® 1% permethrin creme rinse, applied for 10 minutes to pre-washed and towel dried hair before rinsing off with water, with a repeat treatment one week later. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Hedrin® Once liquid gel, Lyclear® 1% |
| Primary outcome measure | 1. To demonstrate cure of infestation, defined as no evidence of head lice. 1.1. For Hedrin® Once following a single 15 minute application up to day 14 1.2. For Lyclear® creme rinse using two applications assessed between completion of the second application of treatment on day 7 and day 14 (the first treatment for both products being applied on day 0). |
| Secondary outcome measures | 1. To compare the efficacy of Hedrin® Once with Lyclear® creme rinse and to identify superiority of one product over the other if appropriate. 2. Safety of the products monitored by observation for adverse events on days 0, 1, 6, 7, 9, and 14 of the study |
| Overall study start date | 01/06/2011 |
| Overall study end date | 31/10/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 84 (randomised by household) from an estimated 44 households, divided into two groups of 42 |
| Participant 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 |
| Participant exclusion criteria | 1. Participants with a known sensitivity to any of the ingredients in Hedrin® Once liquid gel or Lyclear® 1% permethrin creme rinse, pyrethroid insecticides, or plants related to dandelions or chrysanthemums. 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 one month before entry to this study 8. People who have already participated in this clinical study |
| Recruitment start date | 01/06/2011 |
| Recruitment end date | 31/10/2011 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Medical Entomology Centre
Cambridge
CB25 9AU
United Kingdom
CB25 9AU
United Kingdom
Sponsor information
Thornton & Ross Ltd (UK)
Industry
Industry
Linthwaite Laboratories
Linthwaite
Huddersfield
HD7 5QH
United Kingdom
| Phone | +44 (0)148 484 2217 |
|---|---|
| ashleybrierley@thorntonross.com | |
| Website | http://www.thorntonross.com |
"ROR" |
https://ror.org/00frd0c49 |
Funders
Funder type
Industry
Thornton & Ross Ltd (UK)
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 | 01/04/2013 | Yes | No | |
| HRA research summary | 28/06/2023 | No | No |
