Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202208887378021 Date of Registration: 23/08/2022
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Evaluation of the effectiveness of “Shega” solution as compared to Permethrin lotion in eliminating head lice in infested school children in Gondar town and Gondar Zurya District: A non-inferiority Study
Official scientific title Evaluation of the effectiveness of “Shega” solution as compared to Permethrin lotion in eliminating head lice in infested school children in Gondar town and Gondar Zurya District: A non-inferiority Study
Brief summary describing the background and objectives of the trial In Ethiopia, the prevalence of head lice is high. In Woreta town in particular, it has been reported to be 65%. In general, the head lice infestation has negative impact such as socioeconomic crises, social stigma and negative health impacts. Although there are different conventional medicines developed for cure so far, the lack of accessibility and affordability by all group of people is still continuing to be a problem. Therefore, the Antenna Foundation, a non-governmental organization based in Switzerland, has come up with a natural formula inspired by Brazilian traditional recipes, and which is based of vinegar, water, and salt. The effectiveness of several versions of this solution were tested in Brazil and Nepal, and it has been reported to be 55.2% in Brazil and 71,1% in Nepal, with thus 14.4% more lice elimination than the standard Nepalese treatment, mustard oil. The present non-inferiority study aims at assessing the effectiveness of a version of this solution called “Shega” solution in the Ethiopian context, and in particular, without the use of an anti-lice comb and compared with the standard treatment Permethrin 1% lotion. The trial will take place in schools after having opened dialogue with a theatre about head-lice.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Headlice
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Supportive care
Anticipated trial start date 03/10/2022
Actual trial start date
Anticipated date of last follow up 05/02/2023
Actual Last follow-up date
Anticipated target sample size (number of participants) 497
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL Campos Nogueira R, Nonato FR, Duchene Veauvy MC, Cavin AL, Al-Anbaki M, Graz B. Head Lice at School: Traditional Medicine and Community Engagement. Health Equity. 2021 May 13;5(1):310-315. doi: 10.1089/heq.2020.0065. PMID: 34036214; PMCID: PMC8139259
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Shega group Shega solution will be made of salt 5%, vinegar 1%, glycerin 5%, and water. Shega solution will be applied on dry hair until it became totally wet, comb with normal comb after 1 hour, leave it and wash as usual after a minimum of 24 hours. These steps have to be repeated twice at 1 week interval for a total of 3 applications (D0, D7, and D14). The total duration of the treatment will be 3 weeks and the child will be checked for the presence of headlice after 1 or 2 days (D15/D16). If head lice are still present after 3 weeks, a 4th application can be made. The intervention will be done by trained staff at school. Untangle hair. Apply the solution on dry hair until it became totally wet, comb with normal comb after 1 hour, leave it and wash as usual after a minimum of 24 hours. These steps have to be repeated twice at 1 week interval for a total of 3 applications (D0, D7, and D14). On day D15 or D16, participants will be examined first by visual inspection. If no lice detected by visual inspection, wet combing method will be used. Siblings will be treated if necessary at home by Permethrin 1% lotion. 249
Control Group Permethrin group Permethrin 1% lotion, applied 3 times at 1 week intervall (D0, D7, D14) 3 weeks of intervention, then control at D15 or D16. The intervention will be perfomed by trained staff at school. Untangle hair, apply the Permethrin lotion on damp hair, leave for 10 minutes and during this time, comb with a normal comb. Then rinsed thoroughly. These steps have to be repeated twice at 1 week interval for a total of 3 applications (D0, D7, and D14). On day D15 or D16, participants will be examined first by visual inspection. If no lice detected by visual inspection, wet combing method will be used. Siblings will be treated if necessary at home by Permethrin 1% lotion. 249 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Schoolchildren from grade 1 to 8 affected by head lice, in the form of eggs and/or adults, who will give their consent and whose guardians/parents will give assent. Subjects affected by scalp disorders or diseases History of irritation or sensitivity to pediculicides or hair care products Treatment with a pediculicide within 1 week prior to the study Adolescent: 13 Year(s)-17 Year(s),Child: 6 Year-12 Year 6 Year(s) 15 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 10/08/2022 Ministry of Education via its National Research Ethics Review Committee
Ethics Committee Address
Street address City Postal code Country
P.O. box 1367, Arada sub-city Addis Ababa 2000 Ethiopia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The primary outcome is to determine the efficiency of a Shega solution in the Ethiopian context and in particular without the use of an anti-lice comb, but with a normal comb versus Permethrin treatment. 15 or 16 days
Secondary Outcome To assess the effectiveness of Permethrin 1% lotion, applied 3 times and without the use of an anti-lice comb. 15 or 16 days
Secondary Outcome To evaluate the possible side effect of both solutions 15 or 16 days
Secondary Outcome To evaluate the feasibility and the possible scale up of using the Beautiful Hair program (with Shega solution+ theatre) to eradicate head lice amongst schoolchildren in Ethiopia. 15 or 16 days
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Gondar city school Castle street Gondar 0000 Ethiopia
FUNDING SOURCES
Name of source Street address City Postal code Country
Antenna Foundation Av. de la Grenade 24 Geneva 1207 Switzerland
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Antenna Foundation Av. de la Grenade 24 Geneva 1207 Switzerland Charities/Societies/Foundation
COLLABORATORS
Name Street address City Postal code Country
Tewodros Ayalew Maraki 196 Gondar 0000 Ethiopia
Abyot Endale Maraki 196 Gondar 0000 Ethiopia
Henok Dagne Maraki 196 Gondar 0000 Ethiopia
AnneLaure Cavin Av. de la Grenade 24 Geneva 1207 Switzerland
Bertrand Graz Av. de la Grenade 24 Geneva 1207 Switzerland
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Tewodros Ayalew tayalew950@gmail.com +251913997363 Maraki 196
City Postal code Country Position/Affiliation
Gondar 0000 Ethiopia Researcher at University of Gondar
Role Name Email Phone Street address
Scientific Enquiries Abyot Endale abyot.endale@gmail.com +251913399986 Maraki 196
City Postal code Country Position/Affiliation
Gondar 0000 Ethiopia Head of the school of Pharmacy
Role Name Email Phone Street address
Public Enquiries AnneLaure Cavin alcavin@antenna.ch +41792596379 Av. de la Grenade 24
City Postal code Country Position/Affiliation
Geneva 1207 Switzerland Researcher and Project manager
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes IPD Will be kept in a safe location in the Gondar University. It will be available in an anonymous manner upon request and after deidentification Study Protocol It will be available in an anonymous manner upon request from April 2023 to March 2032 It will be accessible to any researchers or reviewer who might review the data and perhaps perform some new data analysis, the decision will be in the hands of the Principal investigator and colleagues in Gondar University, plus health and ethical authorities following legislation.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information