Trial Outcomes & Findings for A Study Evaluating the Safety and Efficacy of BGC20-0582 Lice Treatment Gel for Head Lice Infestation (NCT NCT00528021)
NCT ID: NCT00528021
Last Updated: 2022-06-28
Results Overview
Count of participants with No live lice
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
230 participants
Primary outcome timeframe
Day 15 or 22
Results posted on
2022-06-28
Participant Flow
Participant milestones
| Measure |
2.5% BGC20-0582
Active Comparator: 1
Subjects are treated either once (day 1) or twice (day 1 and 7) with either placebo or 2.5% BGC20-0582 topically. Following application of the BG20-0582 lice treatment gel or placebo, the product is rinsed from the subject's hair.
|
10% BGC20-0582
Active Comparator: 2
Subjects are treated either once (day 1) or twice (day 1 and 7) with either placebo or 10% BGC20-0582 topically. Following application of the BGC20-0582 lice treatment gel or placebo, the product is rinsed from the subject's hair.
|
12.5% BGC20-0582
Active Comparator: 3
Subjects are treated either once (day 1) or twice (day 1 and 7) with either placebo or 12.5% BGC20-0582 topically. Following application of the BGC20-0582 lice treatment gel or placebo, the product is rinsed from the subject's hair.
|
Vehicle
Placebo Comparator: 4
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
59
|
59
|
56
|
56
|
|
Overall Study
COMPLETED
|
42
|
46
|
49
|
47
|
|
Overall Study
NOT COMPLETED
|
17
|
13
|
7
|
9
|
Reasons for withdrawal
| Measure |
2.5% BGC20-0582
Active Comparator: 1
Subjects are treated either once (day 1) or twice (day 1 and 7) with either placebo or 2.5% BGC20-0582 topically. Following application of the BG20-0582 lice treatment gel or placebo, the product is rinsed from the subject's hair.
|
10% BGC20-0582
Active Comparator: 2
Subjects are treated either once (day 1) or twice (day 1 and 7) with either placebo or 10% BGC20-0582 topically. Following application of the BGC20-0582 lice treatment gel or placebo, the product is rinsed from the subject's hair.
|
12.5% BGC20-0582
Active Comparator: 3
Subjects are treated either once (day 1) or twice (day 1 and 7) with either placebo or 12.5% BGC20-0582 topically. Following application of the BGC20-0582 lice treatment gel or placebo, the product is rinsed from the subject's hair.
|
Vehicle
Placebo Comparator: 4
|
|---|---|---|---|---|
|
Overall Study
Lack of Efficacy
|
17
|
13
|
7
|
9
|
Baseline Characteristics
A Study Evaluating the Safety and Efficacy of BGC20-0582 Lice Treatment Gel for Head Lice Infestation
Baseline characteristics by cohort
| Measure |
2.5% BGC20-0582
n=59 Participants
|
10% BGC20-0582
n=59 Participants
|
12.5% BGC20-0582
n=56 Participants
|
Vehicle
n=56 Participants
|
Total
n=230 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
55 Participants
n=93 Participants
|
56 Participants
n=4 Participants
|
55 Participants
n=27 Participants
|
55 Participants
n=483 Participants
|
221 Participants
n=36 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
9 Participants
n=36 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Age, Continuous
|
12.3 years
STANDARD_DEVIATION 11.5 • n=93 Participants
|
13.5 years
STANDARD_DEVIATION 12.1 • n=4 Participants
|
13 years
STANDARD_DEVIATION 10.2 • n=27 Participants
|
12.3 years
STANDARD_DEVIATION 8.8 • n=483 Participants
|
12.8 years
STANDARD_DEVIATION 10.7 • n=36 Participants
|
|
Sex: Female, Male
Female
|
54 Participants
n=93 Participants
|
54 Participants
n=4 Participants
|
49 Participants
n=27 Participants
|
49 Participants
n=483 Participants
|
206 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
7 Participants
n=27 Participants
|
7 Participants
n=483 Participants
|
24 Participants
n=36 Participants
|
|
Region of Enrollment
United States
|
59 participants
n=93 Participants
|
59 participants
n=4 Participants
|
56 participants
n=27 Participants
|
56 participants
n=483 Participants
|
230 participants
n=36 Participants
|
PRIMARY outcome
Timeframe: Day 15 or 22Count of participants with No live lice
Outcome measures
| Measure |
2.5% BGC20-0582
n=42 Participants
Active Comparator: 1
Subjects are treated either once (day 1) or twice (day 1 and 7) with either placebo or 2.% BGC20-582 topically. Following application of the BGC20-0582 lice treatment gel or placebo, the product is rinsed from the subject's hair.
|
10% BGC20-0582
n=46 Participants
Active Comparator: 2
Subject's are treated either once (day 1) or twice (day 1 and 7) with either placebo or 10% BGC20-0582 topically. Following application of the BGC20-0582 lice treatment gel or placebo, the product is rinsed from the subject's hair.
|
12.5% BGC20-0582
n=49 Participants
Active Comparator: 3
Subject's are treated either once (day 1) or twice (day 1 and 7) with either placebo or 12.5% BG20-0582 TOPICALLY. Following application of the BGC20-0582 lice treatment gel or placebo, the product is rinsed from the subject's hair.
|
Vehicle
n=47 Participants
Placebo Comparator: 4
|
|---|---|---|---|---|
|
Clinical Cure
|
30 Participants
|
28 Participants
|
35 Participants
|
32 Participants
|
Adverse Events
2.5% BGC20-0582
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
10% BGC20-0582
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
12.5% BGC20-0582
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
Vehicle
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
2.5% BGC20-0582
n=59 participants at risk
|
10% BGC20-0582
n=59 participants at risk
|
12.5% BGC20-0582
n=56 participants at risk
|
Vehicle
n=56 participants at risk
|
|---|---|---|---|---|
|
General disorders
Application site irritation
|
13.6%
8/59 • Number of events 8
|
8.5%
5/59 • Number of events 5
|
14.3%
8/56 • Number of events 8
|
5.4%
3/56 • Number of events 3
|
|
General disorders
Application site pruritis
|
6.8%
4/59 • Number of events 4
|
3.4%
2/59 • Number of events 2
|
3.6%
2/56 • Number of events 2
|
8.9%
5/56 • Number of events 5
|
|
Skin and subcutaneous tissue disorders
Dandruff
|
5.1%
3/59 • Number of events 3
|
8.5%
5/59 • Number of events 5
|
14.3%
8/56 • Number of events 8
|
8.9%
5/56 • Number of events 5
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60