Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Intermittent application of a natural repellent against Tunga penetrans to reduce intensity of infestation and associated morbidity in an endemic area: a randomised controlled trial
Acronym
Study hypothesis
1. Compare the efficacy of different schemes of prophylactic application of a natural repellent based on coconut oil to reduce infestation intensity and associated morbidity in a high transmission area
2. Reduce the pathology of tungiasis
3. Identify the frequency of application to effectively reduce tungiasis
4. Open new pathways for cost-effective control of tungiasis
Ethics approval
Ethical Committee of the Federal University of Ceará, Brazil, approved in January 2005
Study design
Randomised (permuted block design) controlled single centre trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Tungiasis
Intervention
After the admission examination the participants were randomised into three cohorts (A, B and C). In the first phase of the study individuals received a twice-daily application of Zanzarin® for a period of four weeks. It was anticipated that this reduced the number of embedded sand fleas to almost zero. Thereafter participants were examined again and the degree of the tungiasis-associated morbidity was assessed. These data provided the baseline for the subsequent study phase.
During a period of five months members of Cohort A applied the repellent every second week twice daily for one week and members of Cohort B every fourth week for one week. Cohort C served as control group and did not receive any protection.
During the intervention periods Zanzarin® was applied onto the feet by trained community health workers as described previously. The average volume applied was 3 ml per person and day. Prophylaxis was performed in the morning between 6 and 8 a.m. and in the evening between 6 and 8 p.m. The exact time of application was recorded for each study participant. The application of the repellent was regularly checked by random visits to the households of the study participants by one of the investigators.
In addition, at each examination the participants were asked whether the repellent had been applied regularly. This ensured that the repellent was applied exactly as defined in the study protocol, not spilled, given away for money or stolen. The participants were asked not to wash their feet for at least two hours after application of the repellent. However, they were allowed to take a shower whenever they wanted.
Intervention type
Drug
Phase
Not Applicable
Drug names
Zanzarin®
Primary outcome measure
The whole body surface was examined for the presence of immature, egg-producing or dead fleas and manipulated lesions. Tungiasis lesions were classified according to the Fortaleza Classification. The following findings were considered diagnostic for tungiasis:
1. Flea in statu penetrandi (stage I)
2. A dark and itching spot in the epidermis with a diameter of 1 to 2 mm, with or without local pain and itching (early lesion, stage II)
3. Lesions presenting as a white halo with a diameter of 3 to 10 mm with a central black dot (mature egg producing flea, stage III)
4. A brownish-black circular crust with or without surrounding necrosis of the epidermis (dead parasite, stage IV)
During monitoring the number of viable (stage I to III) and dead (stage IV) sand fleas and the total number of sand flea lesions were determined. Clinical pathology was documented every four weeks. Lesions manipulated by the patient (such as partially or totally eliminated fleas leaving a characteristic crater-like sore in the skin) and suppurative lesions caused by the use of non-sterile perforating instruments such as needles and thorns, were documented as well. The exact topographic localisation of each lesion, its stage, and appearance were documented on a visual record sheet.
Secondary outcome measures
Clinical pathology was assessed in a semi-quantitative manner using a previously elaborated severity score for acute tungiasis (SSAT) and a severity score for chronic tungiasis (SSCT). The SSAT score comprises the following signs and symptoms: erythema, oedema, pain upon pressure or spontaneously, itching, sleep disturbance due to itching, difficulty walking as indicated by an altered gait; abscess and suppuration as indicators of superinfection; fissures and ulcers as characteristic chronic skin defects. The score can take a value from 0 to 24 points. The SSCT ranges from 0 to 33 points and comprises the presence of nail deformation, nail loss, brilliant skin (an indicator of chronic oedema), deformation of toes; hypertrophic nail rim and perilesional desquamation; the latter two characteristics are indicators of repeated tungiasis experienced in the past.
Overall trial start date
01/06/2005
Overall trial end date
18/12/2005
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Individuals with tungiasis identified with the assistance of community health workers
2. Aged 1 - 66 years, either sex
3. At least 5 embedded sand fleas in stage 1 to 4 of the Fortaleza Classification or a similar number of sand flea lesions manipulated with a perforating instrument
Participant type
Patient
Age group
Other
Gender
Both
Target number of participants
140
Participant exclusion criteria
1. Intended to change their place of residence during the next six months
2. Ulcerated lesions necessitating antibiotic treatment
3. Children aged less than one year
Recruitment start date
01/06/2005
Recruitment end date
18/12/2005
Locations
Countries of recruitment
Brazil
Trial participating centre
Charite- Campus Benjamin Franklin
Berlin
12203
Germany
Sponsor information
Organisation
Charité - University Medicine Berlin (Charité - Universitätsmedizin Berlin) (Germany)
Sponsor details
Campus Benjamin Franklin
Institute of Microbiology and Hygiene
Hindenburgdamm 30
Berlin
12203
Germany
Sponsor type
University/education
Website
Funders
Funder type
Government
Funder name
DAAD-CAPES PROBRAL program (Germany) (ref: 152/02)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Engelhard Arzneimittel, Niederdorfelden (Germany) - provided the repellent (Zanzarin®) free of charge
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17486257
Publication citations
-
Results
Ariza L, Seidenschwang M, Buckendahl J, Gomide M, Feldmeier H, Heukelbach J, [Tungiasis: a neglected disease causing severe morbidity in a shantytown in Fortaleza, State of Ceará]., Rev. Soc. Bras. Med. Trop., 40, 1, 63-67.