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| Name | Class |
|---|---|
| Bernhard Nocht Institute for Tropical Medicine | OTHER_GOV |
| University Hospital Tuebingen | OTHER |
| Medical University of Vienna | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Individual Treatment | Active Comparator |
| |
| Household Treatment | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Benzyl Benzoate 25% Topical Application Lotion | Drug | Applied to skin for the treatment of scabies |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Clinical Cure | clinical improvement in skin lesions with no new lesions occurring since treatment application as assessed by skin examination | after 28 days from baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Affected Household Members Per Household | proportion of scabies cases per household after 4 weeks | after 28 days from baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre de Recherches Médicales de Lambaréné | Lambaréné | BP 242 | Gabon |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32589632 | Derived | Matthewman J, Manego RZ, Dimessa Mbadinga LB, Sinkovec H, Volker K, Akinosho M, Haedrich C, Tardif d'Hamonville J, Lell B, Adegnika AA, Ramharter M, Mombo-Ngoma G. A randomized controlled trial comparing the effectiveness of individual versus household treatment for Scabies in Lambarene, Gabon. PLoS Negl Trop Dis. 2020 Jun 26;14(6):e0008423. doi: 10.1371/journal.pntd.0008423. eCollection 2020 Jun. |
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| ID | Type | URL | Comment |
|---|---|---|---|
| Individual Participant Data Set | View IPD |
IPD with identifying data removed uploaded to public repository under https://www.kaggle.com/julianmatthewman/grattigratta-data
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| ID | Title | Description |
|---|---|---|
| FG000 | Individual Treatment | Benzyl Benzoate 25% Topical Application Lotion: Applied to skin for the treatment of scabies |
| FG001 | Household Treatment | Benzyl Benzoate 25% Topical Application Lotion: Applied to skin for the treatment of scabies |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Individual Treatment | Benzyl Benzoate 25% Topical Application Lotion: Applied to skin for the treatment of scabies |
| BG001 | Household Treatment | Benzyl Benzoate 25% Topical Application Lotion: Applied to skin for the treatment of scabies |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Posted | Count of Participants | Participants | after 28 days from baseline |
|
over the study follow up period, an average of 4 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Individual Treatment | Benzyl Benzoate 25% Topical Application Lotion: Applied to skin for the treatment of scabies |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Julian Matthewman | CERMEL | 00241 07-98-91-91 | julianmatthewman@gmail.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 31, 2018 | Oct 21, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D012532 | Scabies |
| ID | Term |
|---|---|
| D008924 | Mite Infestations |
| D004478 | Ectoparasitic Infestations |
| D012876 | Skin Diseases, Parasitic |
| D010272 | Parasitic Diseases |
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| ID | Term |
|---|---|
| C006723 | benzyl benzoate |
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| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Scabies severity | Count of Participants | Participants |
|
| Malaria rapid diagnostic test status | Count of Participants | Participants |
|
| Units | Counts |
|---|
| Participants |
|
|
| Secondary | Proportion of Affected Household Members Per Household | proportion of scabies cases per household after 4 weeks | Not Posted | after 28 days from baseline | Participants |
| 0 |
| 47 |
| 0 |
| 47 |
| 0 |
| 47 |
| EG001 | Household Treatment | Benzyl Benzoate 25% Topical Application Lotion: Applied to skin for the treatment of scabies | 0 | 57 | 0 | 57 | 0 | 57 |
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| D007239 | Infections |
| D012874 | Skin Diseases, Infectious |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |