Comparative insect repellency study of combined lemongrass and peppermint oil lotion versus 25% DEET lotion against mosquitoes
| ISRCTN | ISRCTN23577135 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN23577135 |
| Secondary identifying numbers | 2021-17 |
- Submission date
- 17/01/2024
- Registration date
- 09/02/2024
- Last edited
- 17/01/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Plain English Summary
Background and study aims
Dengue is a mosquito-borne viral infection endemic in the Philippines. One of the strategies advocated by the WHO to obtain protection from mosquitoes is the use of repellents. DEET-based repellents have been widely used but are known to cause adverse effects. This study tests an alternative and effective plant-based repellent. This study aims to compare the repellency action of lemongrass and peppermint oil lotion against DEET lotion against female Aedes aegypti mosquitoes.
Who can participate?
Healthy volunteers aged 18-40 years old
What does the study involve?
Participants were randomly allocated to one of two groups to have 5.0 grams of combined lemongrass and peppermint oil lotion or 5.0 grams of 25% DEET lotion applied from wrist to elbow. The repellent was dried before the arm was inserted into the cage containing 100 female mosquitoes, exposed for 3 minutes and observed for landing or probing. The procedure was repeated every hour for up to 6 hours. The occurrence of one landing and/or probing within 3 minutes indicates the end of complete protection time. Protection over time was determined using the same procedure from the treated versus untreated control arm.
What are the possible benefits and risks of participating?
This study involves moderate risks. Classification of combined lemongrass oil and peppermint oil lotion as non-irritant and safe will prompt the continuation of the study to the next phase. Possible adverse events range from mild symptoms, such as erythema (redness), itching, dryness, scaling or stinging; moderate symptoms such as burning, tenderness or pain; to severe symptoms such as formation of vesicles, erosions and/or crusting. However, no adverse events were noted throughout the study.
Where is the study run from?
Entomology Laboratory Standards and Testing Division, Industrial Technology Development Institute, Department of Science and Technology (Philippines)
When is the study starting and how long is it expected to run for?
January 2021 to October 2022
Who is funding the study?
1. League of Asean Dermatological Societies (LADS) (Philippines)
2. Philippine Dermatology Society (PDS) (Philippines)
Who is the main contact?
Dr Aira Monica R. Abella, aika2122001@gmail.com
Contact information
Public, Scientific, Principal Investigator
Unit 2529-2530 Rio Tower - The Capital Towers E. Rodriguez Sr. Avenue
Quezon City
1112
Philippines
 ORCID ID |
0009-0006-5169-7866 |
|---|---|
| Phone | +63 (0)9175714806 |
| aika2122001@gmail.com |
Study information
| Study design | Randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Laboratory |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Comparative study of the insect repellency action of combined lemongrass oil and peppermint oil lotion versus 25% DEET (N,N-diethyl-meta-toluamide) lotion against female Aedes aegypti mosquitoes |
| Study hypothesis | There is a statistically significant difference in repellency between 25% DEET lotion and combined lemongrass oil and peppermint oil lotion based on the percentage protection against female Aedes aegypti mosquitoes. |
| Ethics approval(s) |
Approved 25/08/2021, Institutional Review Board, Research Institute for Tropical Medicine (9002 Research Drive, Filinvest Corporate City, Alabang, Muntinlupa City, 1781, Philippines; +63 (0)632 88097599; irb@ritm.gov.ph), ref: 2021-17 |
| Condition | Dengue |
| Intervention | Participants were randomized by simple randomization to one of two treatment groups. 5 grams of Repellent A - Combined Lemongrass and Peppermint oil lotion and 5 grams of Positive Control Repellent B - 25% DEET lotion were applied from wrist to elbow per treatment group. Repellent was dried before inserting into the cage containing 100 female mosquitoes, exposed for 3 minutes and observed for landing or probing. The procedure was repeated every hour up to 6 hours. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | Not Applicable |
| Phase | Phase 0 |
| Drug / device / biological / vaccine name(s) | 25% DEET (N,N-diethyl-meta-toluamide) lotion, combined lemongrass oil and peppermint oil lotion |
| Primary outcome measure | The % protection over time was determined by counting the number of mosquitoes landing/probing on the treated arm (T) in relation to the number of landings on the control untreated arm (C) of the same individual (% p = ((C-T)/C)) x 100) for a 3-minute exposure every hour (1 hour, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours). |
| Secondary outcome measures | Complete protection time was calculated as the number of minutes elapsed between the time of repellent application and the first mosquito landing or probing for a 3-minute exposure every hour (1 hour, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours). |
| Overall study start date | 02/01/2021 |
| Overall study end date | 10/10/2022 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 40 Years |
| Sex | Both |
| Target number of participants | 46 |
| Total final enrolment | 46 |
| Participant inclusion criteria | 1. Healthy male or female aged 18–40 years 2. Must know how to read and write 3. Must be willing to comply with the study protocol requirements 4. Must be willing to sign an informed consent after having clearly understood its content 5. Must be willing to have photos taken for documentation purposes during the experiment |
| Participant exclusion criteria | 1. Pregnant or lactating women 2. Those with a history of allergy or hypersensitivity reactions to insect repellents and its components 3. Those with a history of adverse reactions to insect bite 4. Those who have active skin lesions or other dermatological disorders (like atopic dermatitis, psoriasis) 5. Those with a history of other comorbid conditions (diabetes, hypertension, malignancy) 6. Current or ex-smoker (≥10 pack years) |
| Recruitment start date | 21/04/2022 |
| Recruitment end date | 27/06/2022 |
Locations
Countries of recruitment
- Philippines
Study participating centre
Taguig City
1631
Philippines
Sponsor information
Government
Filinvest Marketing & Exhibit Office
9002 Research Drive
Alabang City
Muntinlupa
1781
Philippines
| Phone | N/A |
|---|---|
| rio@ritm.gov.ph | |
| Website | http://www.ritm.gov.ph/ |
"ROR" |
https://ror.org/01g79at26 |
Funders
Funder type
Other
No information available
No information available
No information available
Results and Publications
| Intention to publish date | 22/07/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. Afterwards patent application and commercialization of product. |
| IPD sharing plan | All raw data will be available including the participants' consent forms. Kindly contact the main author via email, Dr Aira Monica R. Abella (aika2122001@gmail.com). Other files can also be made available: 1. Raw data of results 2. Photographs of methods (ex: laboratory set-up, arm-in-cage procedure, plant materials, etc) 3. List of subject volunteer participants 4. Informed consent forms All data can be shared immediately upon request. Consent from participants was obtained prior to the procedure. |
Editorial Notes
17/01/2024: Study's existence confirmed by the Institutional Review Board, Research Institute for Tropical Medicine.
