Trial Outcomes & Findings for A Phase 2, Muti-Center Study of Repeat Dosing of Squaric Acid Dibutyl Ester in Subjects With Herpes Labialis (NCT NCT03521479)
NCT ID: NCT03521479
Last Updated: 2021-08-06
Results Overview
Local and generalized adverse events with repeat topical application of 2% and 0.5% squaric acid dibutyl ester (SADBE) in subjects with frequent herpes labialis (4 or more episodes in the previous 12 months).
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
40 participants
Primary outcome timeframe
9 months
Results posted on
2021-08-06
Participant Flow
Participant milestones
| Measure |
Group A
Treated with 2% Squaric Acid Dibutyl Ester (SADBE) on day 0 and with 2% SADBE on the visits at week 3, week 6, week 9, and month 8.
Squaric Acid Dibutyl Ester: Repeat topical application of 2% and 0.5% squaric acid dibutyl ester (SADBE) in subjects with frequent herpes labialis (4 or more episodes in the previous 12 months).
|
Group B
Treated with 2% Squaric Acid Dibutyl Ester (SADBE) on day 0 and with 0.5% SADBE on the visits at week 3, week 6, week 9, and month 8.
Squaric Acid Dibutyl Ester: Repeat topical application of 2% and 0.5% squaric acid dibutyl ester (SADBE) in subjects with frequent herpes labialis (4 or more episodes in the previous 12 months).
|
Group C
Treated with 2% Squaric Acid Dibutyl Ester (SADBE) on day 0, month 3, and month 6.
Squaric Acid Dibutyl Ester: Repeat topical application of 2% and 0.5% squaric acid dibutyl ester (SADBE) in subjects with frequent herpes labialis (4 or more episodes in the previous 12 months).
|
Group D
Treated with 2% Squaric Acid Dibutyl Ester (SADBE) on day 0 and month 6.
Squaric Acid Dibutyl Ester: Repeat topical application of 2% and 0.5% squaric acid dibutyl ester (SADBE) in subjects with frequent herpes labialis (4 or more episodes in the previous 12 months).
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
10
|
10
|
|
Overall Study
COMPLETED
|
10
|
10
|
10
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Phase 2, Muti-Center Study of Repeat Dosing of Squaric Acid Dibutyl Ester in Subjects With Herpes Labialis
Baseline characteristics by cohort
| Measure |
Group A
n=10 Participants
Treated with 2% Squaric Acid Dibutyl Ester (SADBE) on day 0 and with 2% SADBE on the visits at week 3, week 6, week 9, and month 8.
Squaric Acid Dibutyl Ester: Repeat topical application of 2% and 0.5% squaric acid dibutyl ester (SADBE) in subjects with frequent herpes labialis (4 or more episodes in the previous 12 months).
|
Group B
n=10 Participants
Treated with 2% Squaric Acid Dibutyl Ester (SADBE) on day 0 and with 0.5% SADBE on the visits at week 3, week 6, week 9, and month 8.
Squaric Acid Dibutyl Ester: Repeat topical application of 2% and 0.5% squaric acid dibutyl ester (SADBE) in subjects with frequent herpes labialis (4 or more episodes in the previous 12 months).
|
Group C
n=10 Participants
Treated with 2% Squaric Acid Dibutyl Ester (SADBE) on day 0, month 3, and month 6.
Squaric Acid Dibutyl Ester: Repeat topical application of 2% and 0.5% squaric acid dibutyl ester (SADBE) in subjects with frequent herpes labialis (4 or more episodes in the previous 12 months).
|
Group D
n=10 Participants
Treated with 2% Squaric Acid Dibutyl Ester (SADBE) on day 0 and month 6.
Squaric Acid Dibutyl Ester: Repeat topical application of 2% and 0.5% squaric acid dibutyl ester (SADBE) in subjects with frequent herpes labialis (4 or more episodes in the previous 12 months).
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
40 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Continuous
|
42.3 years
STANDARD_DEVIATION 11.3 • n=5 Participants
|
39.2 years
STANDARD_DEVIATION 10.1 • n=7 Participants
|
47.1 years
STANDARD_DEVIATION 12.4 • n=5 Participants
|
47.2 years
STANDARD_DEVIATION 13.1 • n=4 Participants
|
43.94 years
STANDARD_DEVIATION 11.83 • n=21 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
23 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
17 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
African American or Black
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
White
|
8 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
32 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=5 Participants
|
10 participants
n=7 Participants
|
10 participants
n=5 Participants
|
10 participants
n=4 Participants
|
40 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 9 monthsLocal and generalized adverse events with repeat topical application of 2% and 0.5% squaric acid dibutyl ester (SADBE) in subjects with frequent herpes labialis (4 or more episodes in the previous 12 months).
Outcome measures
| Measure |
Group A
n=10 Participants
Treated with 2% Squaric Acid Dibutyl Ester (SADBE) on day 0 and with 2% SADBE on the visits at week 3, week 6, week 9, and month 8.
Squaric Acid Dibutyl Ester: Repeat topical application of 2% and 0.5% squaric acid dibutyl ester (SADBE) in subjects with frequent herpes labialis (4 or more episodes in the previous 12 months).
|
Group B
n=10 Participants
Treated with 2% Squaric Acid Dibutyl Ester (SADBE) on day 0 and with 0.5% SADBE on the visits at week 3, week 6, week 9, and month 8.
Squaric Acid Dibutyl Ester: Repeat topical application of 2% and 0.5% squaric acid dibutyl ester (SADBE) in subjects with frequent herpes labialis (4 or more episodes in the previous 12 months).
|
Group C
n=10 Participants
Treated with 2% Squaric Acid Dibutyl Ester (SADBE) on day 0, month 3, and month 6.
Squaric Acid Dibutyl Ester: Repeat topical application of 2% and 0.5% squaric acid dibutyl ester (SADBE) in subjects with frequent herpes labialis (4 or more episodes in the previous 12 months).
|
Group D
n=10 Participants
Treated with 2% Squaric Acid Dibutyl Ester (SADBE) on day 0 and month 6.
Squaric Acid Dibutyl Ester: Repeat topical application of 2% and 0.5% squaric acid dibutyl ester (SADBE) in subjects with frequent herpes labialis (4 or more episodes in the previous 12 months).
|
|---|---|---|---|---|
|
Local and Generalized Adverse Events
Localized reaction (rash, erythema, itching/pruritus, warmth/burning) at application site
|
24 events
|
14 events
|
17 events
|
6 events
|
|
Local and Generalized Adverse Events
Generalized adverse events (related, possible or greater)
|
2 events
|
3 events
|
1 events
|
0 events
|
|
Local and Generalized Adverse Events
Generalized adverse event (unrelated)
|
4 events
|
7 events
|
6 events
|
4 events
|
Adverse Events
Group A
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Group B
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Group C
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Group D
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Group A
n=30 participants at risk；n=10 participants at risk
Treated with 2% Squaric Acid Dibutyl Ester (SADBE) on day 0 and with 2% SADBE on the visits at week 3, week 6, week 9, and month 8.
Squaric Acid Dibutyl Ester: Repeat topical application of 2% and 0.5% squaric acid dibutyl ester (SADBE) in subjects with frequent herpes labialis (4 or more episodes in the previous 12 months).
|
Group B
n=30 participants at risk；n=10 participants at risk
Treated with 2% Squaric Acid Dibutyl Ester (SADBE) on day 0 and with 0.5% SADBE on the visits at week 3, week 6, week 9, and month 8.
Squaric Acid Dibutyl Ester: Repeat topical application of 2% and 0.5% squaric acid dibutyl ester (SADBE) in subjects with frequent herpes labialis (4 or more episodes in the previous 12 months).
|
Group C
n=30 participants at risk；n=10 participants at risk
Treated with 2% Squaric Acid Dibutyl Ester (SADBE) on day 0, month 3, and month 6.
Squaric Acid Dibutyl Ester: Repeat topical application of 2% and 0.5% squaric acid dibutyl ester (SADBE) in subjects with frequent herpes labialis (4 or more episodes in the previous 12 months).
|
Group D
n=30 participants at risk；n=10 participants at risk
Treated with 2% Squaric Acid Dibutyl Ester (SADBE) on day 0 and month 6.
Squaric Acid Dibutyl Ester: Repeat topical application of 2% and 0.5% squaric acid dibutyl ester (SADBE) in subjects with frequent herpes labialis (4 or more episodes in the previous 12 months).
|
|---|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Rash
|
40.0%
4/10 • 172 days
At risk participants listed below as 30 because the 10 participants in each group was counted on 3 separate occasions.
|
0.00%
0/10 • 172 days
At risk participants listed below as 30 because the 10 participants in each group was counted on 3 separate occasions.
|
0.00%
0/10 • 172 days
At risk participants listed below as 30 because the 10 participants in each group was counted on 3 separate occasions.
|
0.00%
0/10 • 172 days
At risk participants listed below as 30 because the 10 participants in each group was counted on 3 separate occasions.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place