Evaluation of Mosquito Repellent Products' Efficacy, Safety, and Public Health Implications
Comparative Evaluation of Mosquito Repellent Products in South Asia and North America: Efficacy, Safety, and Public Health Implications
Human Volunteer Participation:
A total of six (6) healthy adult volunteers participated in the study, including three males and three females aged between 18 and 22 years. The volunteers participated in:
- Arm-in-Cage Test Procedure
- Dermatological Safety Test
All participants were:
- Non-tobacco users
- Free from dermatosis or chronic skin disease
- Free from known allergic reactions to arthropod bites or mosquito repellents
- Informed regarding the objectives, procedures, risks, and benefits of the study Written informed consent was obtained from all volunteers before participation. Participants were instructed not to apply perfumes, aromatics, skincare products, or other mosquito repellents on the hands for at least 12 hours before and during the experiment to minimize experimental bias.
Safety and Ethical Considerations:
- All experiments were conducted under controlled laboratory conditions.
- Appropriate safety precautions and monitoring procedures were maintained throughout the study.
- Volunteers retained the right to withdraw from the study at any stage without penalty.
- Confidentiality and anonymity of volunteer information were strictly maintained.
- No severe physical or psychological risk was associated with participation.
- Immediate medical support and first-aid facilities were available during experimentation.
Studieoversikt
Status
Status
Forhold
Forhold
Intervensjon / Behandling
Intervensjon / Behandling
Studietype
Studietype
Registrering (Faktiske)
Registrering
Fase
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
Dhaka Division
-
Dhaka, Dhaka Division, Bangladesh, 1216
- Biomedical Engineering Department, Military Institute of Science and Technology
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
Tar imot friske frivillige
Beskrivelse
Inclusion Criteria:
- healthy adult volunteers participated
Exclusion Criteria:
- Sick and children
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Antall våpen
Våpen og intervensjoner
Deltakergruppe / ArmDeltakergruppe / Arm |
Intervensjon / BehandlingIntervensjon / Behandling |
|---|---|
|
Eksperimentell: Arm-in-Cage Test Procedure
This arm evaluates the efficacy of commercially available skin-applied mosquito repellent formulations against Aedes albopictus females using a standardized WHO-recommended Arm-in-Cage Test (ACT).
The study assesses mosquito landing/biting protection under controlled laboratory conditions using human volunteers and standardized exposure procedures.
|
Specialized rubber gloves designed to expose only a 4 × 4 cm area of dorsal hand skin while protecting the rest of the hand.
Gloves were replaced between trials to prevent cross-contamination or residual repellent effects.
|
Hva måler studien?
Primære resultatmål
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Number of Mosquito Landings on the Treated Forearm During the WHO Arm-in-Cage Test
Tidsramme: Measured at 0, 1, 2, 4, 6, and 8 hours after repellent application.
|
The number of mosquito landings on the treated forearm will be counted during each exposure period using the standardized WHO Arm-in-Cage Test with 50 unfed female Aedes aegypti mosquitoes.
|
Measured at 0, 1, 2, 4, 6, and 8 hours after repellent application.
|
|
Number of Confirmed Mosquito Bites During the WHO Arm-in-Cage Test
Tidsramme: Measured at 0, 1, 2, 4, 6, and 8 hours after repellent application.
|
The number of confirmed mosquito bites occurring on the treated forearm will be recorded during each exposure period.
|
Measured at 0, 1, 2, 4, 6, and 8 hours after repellent application.
|
|
Complete Protection Time Measured by the WHO Arm-in-Cage Test
Tidsramme: Up to 8 hours after application.
|
Complete Protection Time is defined as the elapsed time from repellent application until the first confirmed mosquito landing or bite.
|
Up to 8 hours after application.
|
|
Percentage Protection Against Mosquito Landing
Tidsramme: Measured at 0, 1, 2, 4, 6, and 8 hours after application
|
Percentage protection will be calculated by comparing the number of mosquito landings on treated skin with the corresponding control observations.
|
Measured at 0, 1, 2, 4, 6, and 8 hours after application
|
Sekundære resultatmål
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Number of Participants With Treatment-Related Skin Reactions
Tidsramme: Within 8 hours after application.
|
The number of participants experiencing erythema, itching, rash, burning sensation, or other treatment-related skin reactions after topical repellent application.
|
Within 8 hours after application.
|
Samarbeidspartnere og etterforskere
Sponsor
Sponsor
Samarbeidspartnere
Samarbeidspartnere
Publikasjoner og nyttige lenker
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Studiestart
Primær fullføring (Faktiske)
Primær fullføring
Studiet fullført (Faktiske)
Studiet fullført
Datoer for studieregistrering
Først innsendt
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Først lagt ut
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Sist oppdatering lagt ut
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
Andre studie-ID-numre
- 2025H009
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .