ScabiesPhase 4NCT04205669
Comparing the Effectiveness of Individual vs. Household Treatment for Scabies in Lambaréné, Gabon
A Phase 4 study testing Benzyl Benzoate 25% Topical Application Lotion in people with Scabies and Households, run by Centre de Recherche Médicale de Lambaréné at 1 site in Gabon.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Scabies, Households
- What is being tested?
- Benzyl Benzoate 25% Topical Application Lotion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteGabon
- Study dates
- 4 Oct 2018to 21 Feb 2019
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- diagnosed with active, uncomplicated scabies
- no known hypersensitivity or allergy against benzyl benzoate
Who cannot join
- hypersensitivity or allergy against benzyl benzoate
- severe superinfection of scabies lesions
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Controlled Trial Comparing the Effectiveness of Individual vs. Household Treatment for Scabies in Lambaréné, Gabon
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.
- Conditions
- Scabies, Households
- Being tested
- Benzyl Benzoate 25% Topical Application Lotion
- Medical subject headings
- Scabies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Benzyl Benzoate 25% Topical Application LotionDrug
Applied to skin for the treatment of scabies
| Study group | Role | What they receive |
|---|---|---|
| Individual Treatment | Active comparator | Not described Receives: Drug: Benzyl Benzoate 25% Topical Application Lotion |
| Household Treatment | Active comparator | Not described Receives: Drug: Benzyl Benzoate 25% Topical Application Lotion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Clinical Cure
clinical improvement in skin lesions with no new lesions occurring since treatment application as assessed by skin examination
Measured: after 28 days from baseline
Secondary outcomes (1)
Proportion of Affected Household Members Per Household
proportion of scabies cases per household after 4 weeks
Measured: after 28 days from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2019
- Study start4 Oct 2018
- Primary completion21 Feb 2019
- Study completion21 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ScabiesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre de Recherche Médicale de Lambaréné
- Sponsor type
- University, hospital or other
- Collaborators
- Bernhard Nocht Institute for Tropical Medicine, University Hospital Tuebingen, Medical University of Vienna
- Responsible party
- Principal investigator, Julian Matthewman, Centre de Recherche Médicale de Lambaréné
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04205669
- Sponsor's protocol ID
- GrattiGratta31082018
- Status last verified
- Oct 2020
- First submitted
- 18 Dec 2019
- Last updated
- 13 Nov 2020
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD with identifying data removed uploaded to public repository under https://www.kaggle.com/julianmatthewman/grattigratta-data
Publications
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.
PubMed 32589632
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial Comparing the Effectiveness of Individual vs. Household Treatment for Scabies in Lambaréné, Gabon
- ClinicalTrials.gov ID
- NCT04205669
- Acronym / sponsor ID
- GrattiGratta31082018
- Conditions
- Scabies, Households
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Centre de Recherche Médicale de LambarénéUniversity, hospital or other
- Collaborators
- Bernhard Nocht Institute for Tropical Medicine, University Hospital Tuebingen, Medical University of Vienna
- Study start
- 4 Oct 2018 (actual)
- Primary completion
- 21 Feb 2019 (actual)
- Study completion
- 21 Feb 2019 (actual)
- First posted
- 19 Dec 2019 (actual)
- Results
- Posted 13 Nov 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Individual Treatment | Active comparator | Drug: Benzyl Benzoate 25% Topical Application Lotion |
| Household Treatment | Active comparator | Drug: Benzyl Benzoate 25% Topical Application Lotion |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- diagnosed with active, uncomplicated scabies
- no known hypersensitivity or allergy against benzyl benzoate
Key exclusion criteria (2 listed)
- hypersensitivity or allergy against benzyl benzoate
- severe superinfection of scabies lesions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Benzyl Benzoate 25% Topical Application LotionApplied to skin for the treatment of scabies | Drug | Household Treatment, Individual Treatment |
Primary outcome
Number of Participants With Clinical Cure
Time frame: after 28 days from baseline
clinical improvement in skin lesions with no new lesions occurring since treatment application as assessed by skin examination
1 secondary outcome
Proportion of Affected Household Members Per Household
Time frame: after 28 days from baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32589632Matthewman 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.
- Individual participant dataSharing planned: Yes. IPD with identifying data removed uploaded to public repository under https://www.kaggle.com/julianmatthewman/grattigratta-data
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Benzyl Benzoate 25% Topical Application Lotion in people with Scabies and Households, run by Centre de Recherche Médicale de Lambaréné at 1 site in Gabon.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Gabon. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Nov 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Clinical Cure (time frame: after 28 days from baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04205669, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2020.