Trial Outcomes & Findings for Comparing the Effectiveness of Individual vs. Household Treatment for Scabies in Lambaréné, Gabon (NCT NCT04205669)
NCT ID: NCT04205669
Last Updated: 2020-11-13
Results Overview
clinical improvement in skin lesions with no new lesions occurring since treatment application as assessed by skin examination
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
104 participants
Primary outcome timeframe
after 28 days from baseline
Results posted on
2020-11-13
Participant Flow
Participant milestones
| Measure |
Individual Treatment
Benzyl Benzoate 25% Topical Application Lotion: Applied to skin for the treatment of scabies
|
Household Treatment
Benzyl Benzoate 25% Topical Application Lotion: Applied to skin for the treatment of scabies
|
|---|---|---|
|
Overall Study
STARTED
|
47
|
57
|
|
Overall Study
COMPLETED
|
34
|
45
|
|
Overall Study
NOT COMPLETED
|
13
|
12
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Individual Treatment
n=47 Participants
Benzyl Benzoate 25% Topical Application Lotion: Applied to skin for the treatment of scabies
|
Household Treatment
n=57 Participants
Benzyl Benzoate 25% Topical Application Lotion: Applied to skin for the treatment of scabies
|
Total
n=104 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
<12 years
|
29 Participants
n=47 Participants
|
36 Participants
n=57 Participants
|
65 Participants
n=104 Participants
|
|
Age, Customized
>=12 years
|
18 Participants
n=47 Participants
|
21 Participants
n=57 Participants
|
39 Participants
n=104 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=47 Participants
|
30 Participants
n=57 Participants
|
52 Participants
n=104 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=47 Participants
|
27 Participants
n=57 Participants
|
52 Participants
n=104 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Scabies severity
Mild
|
6 Participants
n=47 Participants
|
5 Participants
n=57 Participants
|
11 Participants
n=104 Participants
|
|
Scabies severity
Moderate
|
19 Participants
n=47 Participants
|
31 Participants
n=57 Participants
|
50 Participants
n=104 Participants
|
|
Scabies severity
Severe
|
22 Participants
n=47 Participants
|
21 Participants
n=57 Participants
|
43 Participants
n=104 Participants
|
|
Malaria rapid diagnostic test status
Positive
|
22 Participants
n=47 Participants
|
16 Participants
n=57 Participants
|
38 Participants
n=104 Participants
|
|
Malaria rapid diagnostic test status
Negative
|
25 Participants
n=47 Participants
|
41 Participants
n=57 Participants
|
66 Participants
n=104 Participants
|
PRIMARY outcome
Timeframe: after 28 days from baselineclinical improvement in skin lesions with no new lesions occurring since treatment application as assessed by skin examination
Outcome measures
| Measure |
Individual Treatment
n=34 Participants
Benzyl Benzoate 25% Topical Application Lotion: Applied to skin for the treatment of scabies
|
Household Treatment
n=45 Participants
Benzyl Benzoate 25% Topical Application Lotion: Applied to skin for the treatment of scabies
|
|---|---|---|
|
Number of Participants With Clinical Cure
|
20 Participants
|
33 Participants
|
SECONDARY outcome
Timeframe: after 28 days from baselineproportion of scabies cases per household after 4 weeks
Outcome measures
Outcome data not reported
Adverse Events
Individual Treatment
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Household Treatment
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place