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Randomized Controlled Trial
. 2017 Mar 24;12(3):e0172566.
doi: 10.1371/journal.pone.0172566. eCollection 2017.

Safety of a topical insect repellent (picaridin) during community mass use for malaria control in rural Cambodia

Somony Heng  1   2 , Vincent Sluydts  2   3 , Lies Durnez  2 , Vanna Mean  1 , Koh Polo  4 , Sochantha Tho  1 , Marc Coosemans  2   5 , Johan van Griensven  2
Affiliations
Randomized Controlled Trial

Safety of a topical insect repellent (picaridin) during community mass use for malaria control in rural Cambodia

Somony Heng et al. PLoS One. .

Abstract

Background: While community distribution of topical repellents has been proposed as an additional malaria control intervention, the safety of this intervention at the population level remains poorly evaluated. We describe the safety of mass distribution of the picaridin repellent during a cluster-randomised trial in rural Cambodia in 2012-2013.

Methods: The repellent was distributed among 57 intervention villages with around 25,000 inhabitants by a team of village distributors. Information on individual adverse events, reported by phone by the village distributors, was obtained through home visits. Information on perceived side effects, reported at the family level, was obtained during two-weekly bottle exchange. Adverse events were classified as adverse reactions (events likely linked to the repellent), cases of repellent abuse and events not related to the repellent use, and classified as per Common Terminology Criteria for Adverse Events.

Findings: Of the 41 adverse events notified by phone by the village distributors, there were 22 adverse reactions, 11 cases of repellent abuse (6 accidental, 5 suicide attempts) and 8 non-related events. All adverse reactions were mild, occurred in the first few months of use, and mainly manifested as skin conditions. Of the 11 cases of abuse, 2 were moderate and 2 life-threatening. All cases with adverse reactions and repellent abuse recovered completely. 20% of families reported perceived side effects, mainly itching, headache, dizziness and bad smell, but few discontinued repellent use.

Conclusions: Adverse reactions and abuse during mass use of picaridin were uncommon and generally mild, supporting the safety of the picaridin repellent for malaria control.

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Conflict of interest statement

Competing Interests: MC has received a grant from the Bill and Melinda Gates foundation for the submitted work, support from the Belgian Cooperation for Capacity Strengthening of CNM Cambodia. All the repellents used during the study were provided free of charge by the production company, S.C. Johnson. There are no patents, products in development, or marketed products to declare. This does not alter the authors' adherence to all PLOS ONE policies on sharing data and materials.

Figures

Fig 1
Fig 1. Flow chart describing the cluster randomized trial, evaluating the epidemiological efficacy of the introduction of insect repellents at the village level on malaria prevalence.
Safety data reported in the present study come from the intervention arm.
Fig 2
Fig 2. Information flow on AEs, perceived side effects and patient management tree.
Fig 3
Fig 3. Monthly counts of ARs and repellent abuses (oral ingestion), 2012–2013.
Fig 4
Fig 4. Monthly trends of families reporting perceived side effects and average of the actual monthly repellent consumption.
See this image and copyright information in PMC

References

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