A Phase 4 interventional study of Benzyl Benzoate 25% Topical Application Lotion in Scabies and Households, sponsored by Centre de Recherche Médicale de Lambaréné. Completed at 1 site in Gabon. Per ClinicalTrials.gov, last updated 2020-11-13.
Sponsored by Centre de Recherche Médicale de Lambaréné · Phase 4, Interventional, and Treatment
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.
Exclusion Criteria:
Drug: Benzyl Benzoate 25% Topical Application Lotion
Drug: Benzyl Benzoate 25% Topical Application Lotion
Applied to skin for the treatment of scabies
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
Proportion of Affected Household Members Per Household
proportion of scabies cases per household after 4 weeks
Time frame: after 28 days from baseline
| Milestone | Individual Treatment | Household Treatment |
|---|---|---|
| Started | 47 | 57 |
| Completed | 34 | 45 |
| Not completed | 13 | 12 |
clinical improvement in skin lesions with no new lesions occurring since treatment application as assessed by skin examination
| Participants | Individual Treatment | Household Treatment |
|---|---|---|
| Number of Participants With Clinical Cure | 20 | 33 |
proportion of scabies cases per household after 4 weeks
Results for this outcome have not been posted.
Collected over over the study follow up period, an average of 4 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Individual Treatment | 0/47 (0%) | 0/47 (0%) | 0/47 (0%) |
| Household Treatment | 0/57 (0%) | 0/57 (0%) | 0/57 (0%) |
| Age, Customized(Participants) | Individual Treatment | Household Treatment | Total |
|---|---|---|---|
| <12 years | 29 | 36 | 65 |
| >=12 years | 18 | 21 | 39 |
| Sex: Female, Male(Participants) | Individual Treatment | Household Treatment | Total |
|---|---|---|---|
| Female | 22 | 30 | 52 |
| Male | 25 | 27 | 52 |
| Race and Ethnicity Not Collected(Participants) | Individual Treatment | Household Treatment | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Scabies severity(Participants) | Individual Treatment | Household Treatment | Total |
|---|---|---|---|
| Mild | 6 | 5 | 11 |
| Moderate | 19 | 31 | 50 |
| Severe | 22 | 21 | 43 |
| Malaria rapid diagnostic test status(Participants) | Individual Treatment | Household Treatment | Total |
|---|---|---|---|
| Positive | 22 | 16 | 38 |
| Negative | 25 | 41 | 66 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — IPD with identifying data removed uploaded to public repository under https://www.kaggle.com/julianmatthewman/grattigratta-data
This study is completed, as verified in Oct 2020. You cannot join it, but the record below documents what was studied.
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Centre de Recherche Médicale de Lambaréné