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.
51 studies on the registry are indexed under Scabies; 10 are open to participants now.
This study's enrollment of 104 is below the median of 183 across 41 interventional studies indexed under Scabies.
Browse Scabies studies →Centre de Recherche Médicale de Lambaréné is the lead sponsor of 17 studies on the registry; 3 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — IPD with identifying data removed uploaded to public repository under https://www.kaggle.com/julianmatthewman/grattigratta-data
Data sharing details ↗ · www.kaggle.com
Ran from Oct 2018 to primary completion in Feb 2019, 4 months.
Results were first posted in Nov 2020, 1 year 8 months after primary completion.
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Centre de Recherche Médicale de Lambaréné