Households, Scabies
Conditions
Brief summary
It is unclear whether individual treatment of scabies is similarly effective compared to household treatment. This study therefore compares these two treatment strategies with topical benzyl benzoate for treating scabies in Lambaréné and surroundings in Gabon. Subjects presenting with uncomplicated scabies are randomized into either the Individual Treatment group, where only the affected subjects receive treatment, or the Household Treatment group, where all family members are treated in parallel to the affected subjects regardless of signs and symptoms. The primary endpoint is clinical cure after 28 days; the secondary endpoint is the proportion of affected household members per household after 28 days.
Interventions
DRUGBenzyl Benzoate 25% Topical Application Lotion
Applied to skin for the treatment of scabies
Sponsors
Bernhard Nocht Institute for Tropical Medicine
University Hospital Tuebingen
Medical University of Vienna
Centre de Recherche Médicale de Lambaréné
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* diagnosed with active, uncomplicated scabies * no known hypersensitivity or allergy against benzyl benzoate
Exclusion criteria
* hypersensitivity or allergy against benzyl benzoate * severe superinfection of scabies lesions
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Clinical Cure | after 28 days from baseline | clinical improvement in skin lesions with no new lesions occurring since treatment application as assessed by skin examination |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Affected Household Members Per Household | after 28 days from baseline | proportion of scabies cases per household after 4 weeks |
Countries
Gabon
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Individual Treatment Benzyl Benzoate 25% Topical Application Lotion: Applied to skin for the treatment of scabies | 47 |
| Household Treatment Benzyl Benzoate 25% Topical Application Lotion: Applied to skin for the treatment of scabies | 57 |
| Total | 104 |
Baseline characteristics
| Characteristic | Individual Treatment | Household Treatment | Total |
|---|---|---|---|
| Age, Customized <12 years | 29 Participants | 36 Participants | 65 Participants |
| Age, Customized >=12 years | 18 Participants | 21 Participants | 39 Participants |
| Malaria rapid diagnostic test status Negative | 25 Participants | 41 Participants | 66 Participants |
| Malaria rapid diagnostic test status Positive | 22 Participants | 16 Participants | 38 Participants |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Scabies severity Mild | 6 Participants | 5 Participants | 11 Participants |
| Scabies severity Moderate | 19 Participants | 31 Participants | 50 Participants |
| Scabies severity Severe | 22 Participants | 21 Participants | 43 Participants |
| Sex: Female, Male Female | 22 Participants | 30 Participants | 52 Participants |
| Sex: Female, Male Male | 25 Participants | 27 Participants | 52 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 47 | 0 / 57 |
| other Total, other adverse events | 0 / 47 | 0 / 57 |
| serious Total, serious adverse events | 0 / 47 | 0 / 57 |
Outcome results
Primary
Number of Participants With Clinical Cure
clinical improvement in skin lesions with no new lesions occurring since treatment application as assessed by skin examination
Time frame: after 28 days from baseline
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Individual Treatment | Number of Participants With Clinical Cure | 20 Participants |
| Household Treatment | Number of Participants With Clinical Cure | 33 Participants |
Secondary
Proportion of Affected Household Members Per Household
proportion of scabies cases per household after 4 weeks
Time frame: after 28 days from baseline