Trial Outcomes & Findings for Evaluation of Systemic Exposure to VP-102 in Subjects With Molluscum Contagiosum. (NCT NCT03186378)
NCT ID: NCT03186378
Last Updated: 2021-08-11
Results Overview
The primary objective is to determine any potential systemic exposure from a single 24-hour dermal application of VP-102 topical film-forming solution when applied to molluscum contagiosum (molluscum) lesions on pediatric subjects 2 years old and older.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
33 participants
Primary outcome timeframe
24 hours
Results posted on
2021-08-11
Participant Flow
Participant milestones
| Measure |
Exposure Group
This group is open label and allows for up to 16 subjects with 21 or more molluscum lesions will be enrolled. They must complete all blood draws or will be replaced. Intervention Drug: Subjects will receive treatment to their molluscum contagiosum lesions per protocol with VP-102 using the VP-102 applicator.
VP-102 with applicator: Subjects will receive treatment to their molluscum contagiosum with VP-102.
|
Standard Group
This group is open label allowing up to 16 subjects with 20 lesions or less to be enrolled. Drug: Subjects will receive treatment to their molluscum lesions with VP-102 using the VP-102 applicator.
VP-102 with applicator: Subjects will receive treatment to their molluscum contagiosum with VP-102.
|
|---|---|---|
|
Overall Study
STARTED
|
17
|
16
|
|
Overall Study
COMPLETED
|
16
|
16
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Exposure Group
This group is open label and allows for up to 16 subjects with 21 or more molluscum lesions will be enrolled. They must complete all blood draws or will be replaced. Intervention Drug: Subjects will receive treatment to their molluscum contagiosum lesions per protocol with VP-102 using the VP-102 applicator.
VP-102 with applicator: Subjects will receive treatment to their molluscum contagiosum with VP-102.
|
Standard Group
This group is open label allowing up to 16 subjects with 20 lesions or less to be enrolled. Drug: Subjects will receive treatment to their molluscum lesions with VP-102 using the VP-102 applicator.
VP-102 with applicator: Subjects will receive treatment to their molluscum contagiosum with VP-102.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
Baseline Characteristics
Evaluation of Systemic Exposure to VP-102 in Subjects With Molluscum Contagiosum.
Baseline characteristics by cohort
| Measure |
Exposure Group
n=17 Participants
This group is open label and allows for up to 16 subjects with 21 or more molluscum lesions will be enrolled. They must complete all blood draws or will be replaced. Intervention Drug: Subjects will receive treatment to their molluscum contagiosum lesions per protocol with VP-102 using the VP-102 applicator.
VP-102 with applicator: Subjects will receive treatment to their molluscum contagiosum with VP-102.
|
Standard Group
n=16 Participants
This group is open label allowing up to 16 subjects with 20 lesions or less to be enrolled. Drug: Subjects will receive treatment to their molluscum lesions with VP-102 using the VP-102 applicator.
VP-102 with applicator: Subjects will receive treatment to their molluscum contagiosum with VP-102.
|
Total
n=33 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
6.6 years
STANDARD_DEVIATION 3.45 • n=5 Participants
|
6.8 years
STANDARD_DEVIATION 3.15 • n=7 Participants
|
6.7 years
STANDARD_DEVIATION 3.26 • n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
17 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
16 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
17 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Baseline Number of Molluscum Lesions
|
47.4 molluscum lesions
STANDARD_DEVIATION 25.69 • n=5 Participants
|
11.6 molluscum lesions
STANDARD_DEVIATION 6.33 • n=7 Participants
|
30.0 molluscum lesions
STANDARD_DEVIATION 26.07 • n=5 Participants
|
PRIMARY outcome
Timeframe: 24 hoursThe primary objective is to determine any potential systemic exposure from a single 24-hour dermal application of VP-102 topical film-forming solution when applied to molluscum contagiosum (molluscum) lesions on pediatric subjects 2 years old and older.
Outcome measures
| Measure |
Exposure Group
n=16 Participants
This group is open label and allows for up to 16 subjects with 21 or more molluscum lesions will be enrolled. They must complete all blood draws or will be replaced. Intervention Drug: Subjects will receive treatment to their molluscum contagiosum lesions per protocol with VP-102 using the VP-102 applicator.
VP-102 with applicator: Subjects will receive treatment to their molluscum contagiosum with VP-102.
|
Standard Group
This group is open label allowing up to 16 subjects with 20 lesions or less to be enrolled. Drug: Subjects will receive treatment to their molluscum lesions with VP-102 using the VP-102 applicator.
VP-102 with applicator: Subjects will receive treatment to their molluscum contagiosum with VP-102.
|
|---|---|---|
|
The Presence or Absence of Systemic Exposure to Cantharidin by the Collection and Analysis of Plasma Samples From Patients With 21 or More Molluscum Lesions Following Treatment of VP-102.
Any Concentration Level of VP-102 above LLOQ (2.5ng/ml) Pre-treatment · Yes
|
0 Participants
|
—
|
|
The Presence or Absence of Systemic Exposure to Cantharidin by the Collection and Analysis of Plasma Samples From Patients With 21 or More Molluscum Lesions Following Treatment of VP-102.
Any Concentration Level of VP-102 above LLOQ (2.5ng/ml) Pre-treatment · No
|
16 Participants
|
—
|
|
The Presence or Absence of Systemic Exposure to Cantharidin by the Collection and Analysis of Plasma Samples From Patients With 21 or More Molluscum Lesions Following Treatment of VP-102.
Any Concentration Level of VP-102 above LLOQ (2.5ng/ml) 2hr Post Treatment · Yes
|
1 Participants
|
—
|
|
The Presence or Absence of Systemic Exposure to Cantharidin by the Collection and Analysis of Plasma Samples From Patients With 21 or More Molluscum Lesions Following Treatment of VP-102.
Any Concentration Level of VP-102 above LLOQ (2.5ng/ml) 2hr Post Treatment · No
|
15 Participants
|
—
|
|
The Presence or Absence of Systemic Exposure to Cantharidin by the Collection and Analysis of Plasma Samples From Patients With 21 or More Molluscum Lesions Following Treatment of VP-102.
Any Concentration Level of VP-102 above LLOQ (2.5ng/ml) 6hr Post Treatment · Yes
|
0 Participants
|
—
|
|
The Presence or Absence of Systemic Exposure to Cantharidin by the Collection and Analysis of Plasma Samples From Patients With 21 or More Molluscum Lesions Following Treatment of VP-102.
Any Concentration Level of VP-102 above LLOQ (2.5ng/ml) 6hr Post Treatment · No
|
16 Participants
|
—
|
|
The Presence or Absence of Systemic Exposure to Cantharidin by the Collection and Analysis of Plasma Samples From Patients With 21 or More Molluscum Lesions Following Treatment of VP-102.
Any Concentration Level of VP-102 above LLOQ (2.5ng/ml) 24hr Post Treatment · Yes
|
0 Participants
|
—
|
|
The Presence or Absence of Systemic Exposure to Cantharidin by the Collection and Analysis of Plasma Samples From Patients With 21 or More Molluscum Lesions Following Treatment of VP-102.
Any Concentration Level of VP-102 above LLOQ (2.5ng/ml) 24hr Post Treatment · No
|
16 Participants
|
—
|
SECONDARY outcome
Timeframe: Baseline through EOS Day 84Population: Complete Clearance of Molluscum Lesions - Completer Population
Proportion of subjects exhibiting complete clearance of all treated molluscum lesions (baseline and new) on or before Week 12 (EOS).
Outcome measures
| Measure |
Exposure Group
n=16 Participants
This group is open label and allows for up to 16 subjects with 21 or more molluscum lesions will be enrolled. They must complete all blood draws or will be replaced. Intervention Drug: Subjects will receive treatment to their molluscum contagiosum lesions per protocol with VP-102 using the VP-102 applicator.
VP-102 with applicator: Subjects will receive treatment to their molluscum contagiosum with VP-102.
|
Standard Group
n=16 Participants
This group is open label allowing up to 16 subjects with 20 lesions or less to be enrolled. Drug: Subjects will receive treatment to their molluscum lesions with VP-102 using the VP-102 applicator.
VP-102 with applicator: Subjects will receive treatment to their molluscum contagiosum with VP-102.
|
|---|---|---|
|
Measurement of Efficacy - Complete Clearance
Complete Clearance EOS Day 84
|
6 Participants
|
10 Participants
|
|
Measurement of Efficacy - Complete Clearance
Complete Clearance Day 21
|
0 Participants
|
3 Participants
|
|
Measurement of Efficacy - Complete Clearance
Complete Clearance Day 42
|
2 Participants
|
7 Participants
|
|
Measurement of Efficacy - Complete Clearance
Complete Clearance Day 63
|
4 Participants
|
9 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to EOS Day 84Population: ITT Population
Summaries of \>=90% clearance by visit include clearance at that visit or any earlier visit (cumulative) baseline and ew at the EOS visit.
Outcome measures
| Measure |
Exposure Group
n=17 Participants
This group is open label and allows for up to 16 subjects with 21 or more molluscum lesions will be enrolled. They must complete all blood draws or will be replaced. Intervention Drug: Subjects will receive treatment to their molluscum contagiosum lesions per protocol with VP-102 using the VP-102 applicator.
VP-102 with applicator: Subjects will receive treatment to their molluscum contagiosum with VP-102.
|
Standard Group
n=16 Participants
This group is open label allowing up to 16 subjects with 20 lesions or less to be enrolled. Drug: Subjects will receive treatment to their molluscum lesions with VP-102 using the VP-102 applicator.
VP-102 with applicator: Subjects will receive treatment to their molluscum contagiosum with VP-102.
|
|---|---|---|
|
Proportion of Subjects Exhibiting a 90% or Greater Reduction of All Treated Molluscum Lesions (Baseline and New) at the EOS Visit.
>=90% Clearance Day 21
|
0 Participants
|
3 Participants
|
|
Proportion of Subjects Exhibiting a 90% or Greater Reduction of All Treated Molluscum Lesions (Baseline and New) at the EOS Visit.
>=90% Clearance Day 42
|
5 Participants
|
7 Participants
|
|
Proportion of Subjects Exhibiting a 90% or Greater Reduction of All Treated Molluscum Lesions (Baseline and New) at the EOS Visit.
>=90% Clearance Day 63
|
8 Participants
|
10 Participants
|
|
Proportion of Subjects Exhibiting a 90% or Greater Reduction of All Treated Molluscum Lesions (Baseline and New) at the EOS Visit.
>=90% Clearance Day 84
|
12 Participants
|
13 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to EOS Day 84Population: ITT Population
Percent reduction of treated molluscum lesions from Baseline Visit at the EOS visit.
Outcome measures
| Measure |
Exposure Group
n=16 Participants
This group is open label and allows for up to 16 subjects with 21 or more molluscum lesions will be enrolled. They must complete all blood draws or will be replaced. Intervention Drug: Subjects will receive treatment to their molluscum contagiosum lesions per protocol with VP-102 using the VP-102 applicator.
VP-102 with applicator: Subjects will receive treatment to their molluscum contagiosum with VP-102.
|
Standard Group
n=16 Participants
This group is open label allowing up to 16 subjects with 20 lesions or less to be enrolled. Drug: Subjects will receive treatment to their molluscum lesions with VP-102 using the VP-102 applicator.
VP-102 with applicator: Subjects will receive treatment to their molluscum contagiosum with VP-102.
|
|---|---|---|
|
Percent Reduction of Treated Molluscum Lesions From Baseline at the EOS Visit.
|
-87.8 percentage change from Baseline
Standard Deviation 21.25
|
-93.0 percentage change from Baseline
Standard Deviation 12.93
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to EOS Day 84Population: ITT Population
Molluscum Lesions- Change from Baseline visit in the number of treated molluscum lesions at the EOS Day 84 visit
Outcome measures
| Measure |
Exposure Group
n=16 Participants
This group is open label and allows for up to 16 subjects with 21 or more molluscum lesions will be enrolled. They must complete all blood draws or will be replaced. Intervention Drug: Subjects will receive treatment to their molluscum contagiosum lesions per protocol with VP-102 using the VP-102 applicator.
VP-102 with applicator: Subjects will receive treatment to their molluscum contagiosum with VP-102.
|
Standard Group
n=16 Participants
This group is open label allowing up to 16 subjects with 20 lesions or less to be enrolled. Drug: Subjects will receive treatment to their molluscum lesions with VP-102 using the VP-102 applicator.
VP-102 with applicator: Subjects will receive treatment to their molluscum contagiosum with VP-102.
|
|---|---|---|
|
Change From Baseline in the Number of Treated Molluscum Lesions at the EOS Visit.
|
-39.3 change in wart count
Standard Deviation 21.98
|
-10.7 change in wart count
Standard Deviation 6.16
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to EOS Day 84Population: ITT Population
Change from Baseline in quality of life and impact of skin disease as measured by CDLQI assessment, Children's Dermatology Life Quality Index (CDLQI)- Composite Score The CDLQI was a 10-item questionnaire completed by subject/parent to assess skin condition over the previous week. From responses to that questionnaire, a composite score was calculated. The calculated composite score was the sum of the individual 10 items of the CDLQI and could range from 0-30. For each item on the CDLQI, a score of 0-3 was assigned using the following scores per response: * 3: Very much (or Prevented School, Question 7 only) * 2: Quite a lot * 1: Only a little * 0: Not at all
Outcome measures
| Measure |
Exposure Group
n=17 Participants
This group is open label and allows for up to 16 subjects with 21 or more molluscum lesions will be enrolled. They must complete all blood draws or will be replaced. Intervention Drug: Subjects will receive treatment to their molluscum contagiosum lesions per protocol with VP-102 using the VP-102 applicator.
VP-102 with applicator: Subjects will receive treatment to their molluscum contagiosum with VP-102.
|
Standard Group
n=16 Participants
This group is open label allowing up to 16 subjects with 20 lesions or less to be enrolled. Drug: Subjects will receive treatment to their molluscum lesions with VP-102 using the VP-102 applicator.
VP-102 with applicator: Subjects will receive treatment to their molluscum contagiosum with VP-102.
|
|---|---|---|
|
Change From Baseline in Quality of Life and Impact of Skin Disease as Measured by CDLQI Assessment
|
2.71 units on a scale change from Baseline
Standard Deviation 2.801
|
2.44 units on a scale change from Baseline
Standard Deviation 4.115
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to EOS Day 84Population: ITT Population
Spread of molluscum to siblings as measured by any new occurrence of molluscum in siblings of the subject.
Outcome measures
| Measure |
Exposure Group
n=17 Participants
This group is open label and allows for up to 16 subjects with 21 or more molluscum lesions will be enrolled. They must complete all blood draws or will be replaced. Intervention Drug: Subjects will receive treatment to their molluscum contagiosum lesions per protocol with VP-102 using the VP-102 applicator.
VP-102 with applicator: Subjects will receive treatment to their molluscum contagiosum with VP-102.
|
Standard Group
n=16 Participants
This group is open label allowing up to 16 subjects with 20 lesions or less to be enrolled. Drug: Subjects will receive treatment to their molluscum lesions with VP-102 using the VP-102 applicator.
VP-102 with applicator: Subjects will receive treatment to their molluscum contagiosum with VP-102.
|
|---|---|---|
|
Spread to Siblings as Measured by Any New Occurrence of Molluscum in Siblings of the Subject.
|
0 Participants
|
0 Participants
|
Adverse Events
Exposure Group
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
Standard Group
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Exposure Group
n=17 participants at risk
This group is open label and allows for up to 16 subjects with 21 or more molluscum lesions will be enrolled. They must complete all blood draws or will be replaced. Intervention Drug: Subjects will receive treatment to their molluscum contagiosum lesions per protocol with VP-102 using the VP-102 applicator.
VP-102 with applicator: Subjects will receive treatment to their molluscum contagiosum with VP-102.
|
Standard Group
n=16 participants at risk
This group is open label allowing up to 16 subjects with 20 lesions or less to be enrolled. Drug: Subjects will receive treatment to their molluscum lesions with VP-102 using the VP-102 applicator.
VP-102 with applicator: Subjects will receive treatment to their molluscum contagiosum with VP-102.
|
|---|---|---|
|
General disorders
Pain
|
64.7%
11/17 • Baseline to EOS Day 84
Adverse events summaries will only consider (TEAEs). TEAEs are defined as those AEs that occurred after dosing and those existing AEs that worsened during the study. If it cannot be determined whether the AE is treatment emergent due to an incomplete onset date, the AE will be considered to be treatment emergent.
|
50.0%
8/16 • Baseline to EOS Day 84
Adverse events summaries will only consider (TEAEs). TEAEs are defined as those AEs that occurred after dosing and those existing AEs that worsened during the study. If it cannot be determined whether the AE is treatment emergent due to an incomplete onset date, the AE will be considered to be treatment emergent.
|
|
General disorders
Burning Sensation
|
5.9%
1/17 • Baseline to EOS Day 84
Adverse events summaries will only consider (TEAEs). TEAEs are defined as those AEs that occurred after dosing and those existing AEs that worsened during the study. If it cannot be determined whether the AE is treatment emergent due to an incomplete onset date, the AE will be considered to be treatment emergent.
|
0.00%
0/16 • Baseline to EOS Day 84
Adverse events summaries will only consider (TEAEs). TEAEs are defined as those AEs that occurred after dosing and those existing AEs that worsened during the study. If it cannot be determined whether the AE is treatment emergent due to an incomplete onset date, the AE will be considered to be treatment emergent.
|
|
General disorders
Pyrexia
|
5.9%
1/17 • Baseline to EOS Day 84
Adverse events summaries will only consider (TEAEs). TEAEs are defined as those AEs that occurred after dosing and those existing AEs that worsened during the study. If it cannot be determined whether the AE is treatment emergent due to an incomplete onset date, the AE will be considered to be treatment emergent.
|
0.00%
0/16 • Baseline to EOS Day 84
Adverse events summaries will only consider (TEAEs). TEAEs are defined as those AEs that occurred after dosing and those existing AEs that worsened during the study. If it cannot be determined whether the AE is treatment emergent due to an incomplete onset date, the AE will be considered to be treatment emergent.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
17.6%
3/17 • Baseline to EOS Day 84
Adverse events summaries will only consider (TEAEs). TEAEs are defined as those AEs that occurred after dosing and those existing AEs that worsened during the study. If it cannot be determined whether the AE is treatment emergent due to an incomplete onset date, the AE will be considered to be treatment emergent.
|
18.8%
3/16 • Baseline to EOS Day 84
Adverse events summaries will only consider (TEAEs). TEAEs are defined as those AEs that occurred after dosing and those existing AEs that worsened during the study. If it cannot be determined whether the AE is treatment emergent due to an incomplete onset date, the AE will be considered to be treatment emergent.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
5.9%
1/17 • Baseline to EOS Day 84
Adverse events summaries will only consider (TEAEs). TEAEs are defined as those AEs that occurred after dosing and those existing AEs that worsened during the study. If it cannot be determined whether the AE is treatment emergent due to an incomplete onset date, the AE will be considered to be treatment emergent.
|
12.5%
2/16 • Baseline to EOS Day 84
Adverse events summaries will only consider (TEAEs). TEAEs are defined as those AEs that occurred after dosing and those existing AEs that worsened during the study. If it cannot be determined whether the AE is treatment emergent due to an incomplete onset date, the AE will be considered to be treatment emergent.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
11.8%
2/17 • Baseline to EOS Day 84
Adverse events summaries will only consider (TEAEs). TEAEs are defined as those AEs that occurred after dosing and those existing AEs that worsened during the study. If it cannot be determined whether the AE is treatment emergent due to an incomplete onset date, the AE will be considered to be treatment emergent.
|
6.2%
1/16 • Baseline to EOS Day 84
Adverse events summaries will only consider (TEAEs). TEAEs are defined as those AEs that occurred after dosing and those existing AEs that worsened during the study. If it cannot be determined whether the AE is treatment emergent due to an incomplete onset date, the AE will be considered to be treatment emergent.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/17 • Baseline to EOS Day 84
Adverse events summaries will only consider (TEAEs). TEAEs are defined as those AEs that occurred after dosing and those existing AEs that worsened during the study. If it cannot be determined whether the AE is treatment emergent due to an incomplete onset date, the AE will be considered to be treatment emergent.
|
6.2%
1/16 • Baseline to EOS Day 84
Adverse events summaries will only consider (TEAEs). TEAEs are defined as those AEs that occurred after dosing and those existing AEs that worsened during the study. If it cannot be determined whether the AE is treatment emergent due to an incomplete onset date, the AE will be considered to be treatment emergent.
|
|
Respiratory, thoracic and mediastinal disorders
Influenza
|
5.9%
1/17 • Baseline to EOS Day 84
Adverse events summaries will only consider (TEAEs). TEAEs are defined as those AEs that occurred after dosing and those existing AEs that worsened during the study. If it cannot be determined whether the AE is treatment emergent due to an incomplete onset date, the AE will be considered to be treatment emergent.
|
0.00%
0/16 • Baseline to EOS Day 84
Adverse events summaries will only consider (TEAEs). TEAEs are defined as those AEs that occurred after dosing and those existing AEs that worsened during the study. If it cannot be determined whether the AE is treatment emergent due to an incomplete onset date, the AE will be considered to be treatment emergent.
|
|
Respiratory, thoracic and mediastinal disorders
Paranasal sinus hypersecretion
|
0.00%
0/17 • Baseline to EOS Day 84
Adverse events summaries will only consider (TEAEs). TEAEs are defined as those AEs that occurred after dosing and those existing AEs that worsened during the study. If it cannot be determined whether the AE is treatment emergent due to an incomplete onset date, the AE will be considered to be treatment emergent.
|
6.2%
1/16 • Baseline to EOS Day 84
Adverse events summaries will only consider (TEAEs). TEAEs are defined as those AEs that occurred after dosing and those existing AEs that worsened during the study. If it cannot be determined whether the AE is treatment emergent due to an incomplete onset date, the AE will be considered to be treatment emergent.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract congestion
|
0.00%
0/17 • Baseline to EOS Day 84
Adverse events summaries will only consider (TEAEs). TEAEs are defined as those AEs that occurred after dosing and those existing AEs that worsened during the study. If it cannot be determined whether the AE is treatment emergent due to an incomplete onset date, the AE will be considered to be treatment emergent.
|
6.2%
1/16 • Baseline to EOS Day 84
Adverse events summaries will only consider (TEAEs). TEAEs are defined as those AEs that occurred after dosing and those existing AEs that worsened during the study. If it cannot be determined whether the AE is treatment emergent due to an incomplete onset date, the AE will be considered to be treatment emergent.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
5.9%
1/17 • Baseline to EOS Day 84
Adverse events summaries will only consider (TEAEs). TEAEs are defined as those AEs that occurred after dosing and those existing AEs that worsened during the study. If it cannot be determined whether the AE is treatment emergent due to an incomplete onset date, the AE will be considered to be treatment emergent.
|
0.00%
0/16 • Baseline to EOS Day 84
Adverse events summaries will only consider (TEAEs). TEAEs are defined as those AEs that occurred after dosing and those existing AEs that worsened during the study. If it cannot be determined whether the AE is treatment emergent due to an incomplete onset date, the AE will be considered to be treatment emergent.
|
|
Skin and subcutaneous tissue disorders
Scar
|
17.6%
3/17 • Baseline to EOS Day 84
Adverse events summaries will only consider (TEAEs). TEAEs are defined as those AEs that occurred after dosing and those existing AEs that worsened during the study. If it cannot be determined whether the AE is treatment emergent due to an incomplete onset date, the AE will be considered to be treatment emergent.
|
6.2%
1/16 • Baseline to EOS Day 84
Adverse events summaries will only consider (TEAEs). TEAEs are defined as those AEs that occurred after dosing and those existing AEs that worsened during the study. If it cannot be determined whether the AE is treatment emergent due to an incomplete onset date, the AE will be considered to be treatment emergent.
|
|
Skin and subcutaneous tissue disorders
Application site vesicles
|
5.9%
1/17 • Baseline to EOS Day 84
Adverse events summaries will only consider (TEAEs). TEAEs are defined as those AEs that occurred after dosing and those existing AEs that worsened during the study. If it cannot be determined whether the AE is treatment emergent due to an incomplete onset date, the AE will be considered to be treatment emergent.
|
0.00%
0/16 • Baseline to EOS Day 84
Adverse events summaries will only consider (TEAEs). TEAEs are defined as those AEs that occurred after dosing and those existing AEs that worsened during the study. If it cannot be determined whether the AE is treatment emergent due to an incomplete onset date, the AE will be considered to be treatment emergent.
|
|
Skin and subcutaneous tissue disorders
Cellulitis
|
5.9%
1/17 • Baseline to EOS Day 84
Adverse events summaries will only consider (TEAEs). TEAEs are defined as those AEs that occurred after dosing and those existing AEs that worsened during the study. If it cannot be determined whether the AE is treatment emergent due to an incomplete onset date, the AE will be considered to be treatment emergent.
|
0.00%
0/16 • Baseline to EOS Day 84
Adverse events summaries will only consider (TEAEs). TEAEs are defined as those AEs that occurred after dosing and those existing AEs that worsened during the study. If it cannot be determined whether the AE is treatment emergent due to an incomplete onset date, the AE will be considered to be treatment emergent.
|
|
Skin and subcutaneous tissue disorders
Impetigo
|
5.9%
1/17 • Baseline to EOS Day 84
Adverse events summaries will only consider (TEAEs). TEAEs are defined as those AEs that occurred after dosing and those existing AEs that worsened during the study. If it cannot be determined whether the AE is treatment emergent due to an incomplete onset date, the AE will be considered to be treatment emergent.
|
0.00%
0/16 • Baseline to EOS Day 84
Adverse events summaries will only consider (TEAEs). TEAEs are defined as those AEs that occurred after dosing and those existing AEs that worsened during the study. If it cannot be determined whether the AE is treatment emergent due to an incomplete onset date, the AE will be considered to be treatment emergent.
|
|
Skin and subcutaneous tissue disorders
Rash
|
5.9%
1/17 • Baseline to EOS Day 84
Adverse events summaries will only consider (TEAEs). TEAEs are defined as those AEs that occurred after dosing and those existing AEs that worsened during the study. If it cannot be determined whether the AE is treatment emergent due to an incomplete onset date, the AE will be considered to be treatment emergent.
|
0.00%
0/16 • Baseline to EOS Day 84
Adverse events summaries will only consider (TEAEs). TEAEs are defined as those AEs that occurred after dosing and those existing AEs that worsened during the study. If it cannot be determined whether the AE is treatment emergent due to an incomplete onset date, the AE will be considered to be treatment emergent.
|
|
Skin and subcutaneous tissue disorders
Subcutaneous abscess
|
5.9%
1/17 • Baseline to EOS Day 84
Adverse events summaries will only consider (TEAEs). TEAEs are defined as those AEs that occurred after dosing and those existing AEs that worsened during the study. If it cannot be determined whether the AE is treatment emergent due to an incomplete onset date, the AE will be considered to be treatment emergent.
|
0.00%
0/16 • Baseline to EOS Day 84
Adverse events summaries will only consider (TEAEs). TEAEs are defined as those AEs that occurred after dosing and those existing AEs that worsened during the study. If it cannot be determined whether the AE is treatment emergent due to an incomplete onset date, the AE will be considered to be treatment emergent.
|
|
Nervous system disorders
Headache
|
11.8%
2/17 • Baseline to EOS Day 84
Adverse events summaries will only consider (TEAEs). TEAEs are defined as those AEs that occurred after dosing and those existing AEs that worsened during the study. If it cannot be determined whether the AE is treatment emergent due to an incomplete onset date, the AE will be considered to be treatment emergent.
|
18.8%
3/16 • Baseline to EOS Day 84
Adverse events summaries will only consider (TEAEs). TEAEs are defined as those AEs that occurred after dosing and those existing AEs that worsened during the study. If it cannot be determined whether the AE is treatment emergent due to an incomplete onset date, the AE will be considered to be treatment emergent.
|
|
Gastrointestinal disorders
Vomiting
|
5.9%
1/17 • Baseline to EOS Day 84
Adverse events summaries will only consider (TEAEs). TEAEs are defined as those AEs that occurred after dosing and those existing AEs that worsened during the study. If it cannot be determined whether the AE is treatment emergent due to an incomplete onset date, the AE will be considered to be treatment emergent.
|
18.8%
3/16 • Baseline to EOS Day 84
Adverse events summaries will only consider (TEAEs). TEAEs are defined as those AEs that occurred after dosing and those existing AEs that worsened during the study. If it cannot be determined whether the AE is treatment emergent due to an incomplete onset date, the AE will be considered to be treatment emergent.
|
|
Gastrointestinal disorders
Diarrhoea
|
5.9%
1/17 • Baseline to EOS Day 84
Adverse events summaries will only consider (TEAEs). TEAEs are defined as those AEs that occurred after dosing and those existing AEs that worsened during the study. If it cannot be determined whether the AE is treatment emergent due to an incomplete onset date, the AE will be considered to be treatment emergent.
|
6.2%
1/16 • Baseline to EOS Day 84
Adverse events summaries will only consider (TEAEs). TEAEs are defined as those AEs that occurred after dosing and those existing AEs that worsened during the study. If it cannot be determined whether the AE is treatment emergent due to an incomplete onset date, the AE will be considered to be treatment emergent.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/17 • Baseline to EOS Day 84
Adverse events summaries will only consider (TEAEs). TEAEs are defined as those AEs that occurred after dosing and those existing AEs that worsened during the study. If it cannot be determined whether the AE is treatment emergent due to an incomplete onset date, the AE will be considered to be treatment emergent.
|
6.2%
1/16 • Baseline to EOS Day 84
Adverse events summaries will only consider (TEAEs). TEAEs are defined as those AEs that occurred after dosing and those existing AEs that worsened during the study. If it cannot be determined whether the AE is treatment emergent due to an incomplete onset date, the AE will be considered to be treatment emergent.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/17 • Baseline to EOS Day 84
Adverse events summaries will only consider (TEAEs). TEAEs are defined as those AEs that occurred after dosing and those existing AEs that worsened during the study. If it cannot be determined whether the AE is treatment emergent due to an incomplete onset date, the AE will be considered to be treatment emergent.
|
6.2%
1/16 • Baseline to EOS Day 84
Adverse events summaries will only consider (TEAEs). TEAEs are defined as those AEs that occurred after dosing and those existing AEs that worsened during the study. If it cannot be determined whether the AE is treatment emergent due to an incomplete onset date, the AE will be considered to be treatment emergent.
|
|
Infections and infestations
Tinea infection
|
5.9%
1/17 • Baseline to EOS Day 84
Adverse events summaries will only consider (TEAEs). TEAEs are defined as those AEs that occurred after dosing and those existing AEs that worsened during the study. If it cannot be determined whether the AE is treatment emergent due to an incomplete onset date, the AE will be considered to be treatment emergent.
|
0.00%
0/16 • Baseline to EOS Day 84
Adverse events summaries will only consider (TEAEs). TEAEs are defined as those AEs that occurred after dosing and those existing AEs that worsened during the study. If it cannot be determined whether the AE is treatment emergent due to an incomplete onset date, the AE will be considered to be treatment emergent.
|
|
Infections and infestations
Upper respiratory tract infection
|
5.9%
1/17 • Baseline to EOS Day 84
Adverse events summaries will only consider (TEAEs). TEAEs are defined as those AEs that occurred after dosing and those existing AEs that worsened during the study. If it cannot be determined whether the AE is treatment emergent due to an incomplete onset date, the AE will be considered to be treatment emergent.
|
0.00%
0/16 • Baseline to EOS Day 84
Adverse events summaries will only consider (TEAEs). TEAEs are defined as those AEs that occurred after dosing and those existing AEs that worsened during the study. If it cannot be determined whether the AE is treatment emergent due to an incomplete onset date, the AE will be considered to be treatment emergent.
|
|
Psychiatric disorders
Adjustment disorder
|
5.9%
1/17 • Baseline to EOS Day 84
Adverse events summaries will only consider (TEAEs). TEAEs are defined as those AEs that occurred after dosing and those existing AEs that worsened during the study. If it cannot be determined whether the AE is treatment emergent due to an incomplete onset date, the AE will be considered to be treatment emergent.
|
0.00%
0/16 • Baseline to EOS Day 84
Adverse events summaries will only consider (TEAEs). TEAEs are defined as those AEs that occurred after dosing and those existing AEs that worsened during the study. If it cannot be determined whether the AE is treatment emergent due to an incomplete onset date, the AE will be considered to be treatment emergent.
|
|
Psychiatric disorders
Lethargy
|
5.9%
1/17 • Baseline to EOS Day 84
Adverse events summaries will only consider (TEAEs). TEAEs are defined as those AEs that occurred after dosing and those existing AEs that worsened during the study. If it cannot be determined whether the AE is treatment emergent due to an incomplete onset date, the AE will be considered to be treatment emergent.
|
0.00%
0/16 • Baseline to EOS Day 84
Adverse events summaries will only consider (TEAEs). TEAEs are defined as those AEs that occurred after dosing and those existing AEs that worsened during the study. If it cannot be determined whether the AE is treatment emergent due to an incomplete onset date, the AE will be considered to be treatment emergent.
|
|
Psychiatric disorders
Tic
|
5.9%
1/17 • Baseline to EOS Day 84
Adverse events summaries will only consider (TEAEs). TEAEs are defined as those AEs that occurred after dosing and those existing AEs that worsened during the study. If it cannot be determined whether the AE is treatment emergent due to an incomplete onset date, the AE will be considered to be treatment emergent.
|
0.00%
0/16 • Baseline to EOS Day 84
Adverse events summaries will only consider (TEAEs). TEAEs are defined as those AEs that occurred after dosing and those existing AEs that worsened during the study. If it cannot be determined whether the AE is treatment emergent due to an incomplete onset date, the AE will be considered to be treatment emergent.
|
|
Immune system disorders
Asthma
|
5.9%
1/17 • Baseline to EOS Day 84
Adverse events summaries will only consider (TEAEs). TEAEs are defined as those AEs that occurred after dosing and those existing AEs that worsened during the study. If it cannot be determined whether the AE is treatment emergent due to an incomplete onset date, the AE will be considered to be treatment emergent.
|
0.00%
0/16 • Baseline to EOS Day 84
Adverse events summaries will only consider (TEAEs). TEAEs are defined as those AEs that occurred after dosing and those existing AEs that worsened during the study. If it cannot be determined whether the AE is treatment emergent due to an incomplete onset date, the AE will be considered to be treatment emergent.
|
|
Immune system disorders
Hypersensitivity
|
5.9%
1/17 • Baseline to EOS Day 84
Adverse events summaries will only consider (TEAEs). TEAEs are defined as those AEs that occurred after dosing and those existing AEs that worsened during the study. If it cannot be determined whether the AE is treatment emergent due to an incomplete onset date, the AE will be considered to be treatment emergent.
|
0.00%
0/16 • Baseline to EOS Day 84
Adverse events summaries will only consider (TEAEs). TEAEs are defined as those AEs that occurred after dosing and those existing AEs that worsened during the study. If it cannot be determined whether the AE is treatment emergent due to an incomplete onset date, the AE will be considered to be treatment emergent.
|
|
Injury, poisoning and procedural complications
Administration site pain
|
5.9%
1/17 • Baseline to EOS Day 84
Adverse events summaries will only consider (TEAEs). TEAEs are defined as those AEs that occurred after dosing and those existing AEs that worsened during the study. If it cannot be determined whether the AE is treatment emergent due to an incomplete onset date, the AE will be considered to be treatment emergent.
|
0.00%
0/16 • Baseline to EOS Day 84
Adverse events summaries will only consider (TEAEs). TEAEs are defined as those AEs that occurred after dosing and those existing AEs that worsened during the study. If it cannot be determined whether the AE is treatment emergent due to an incomplete onset date, the AE will be considered to be treatment emergent.
|
|
Injury, poisoning and procedural complications
Head injury
|
5.9%
1/17 • Baseline to EOS Day 84
Adverse events summaries will only consider (TEAEs). TEAEs are defined as those AEs that occurred after dosing and those existing AEs that worsened during the study. If it cannot be determined whether the AE is treatment emergent due to an incomplete onset date, the AE will be considered to be treatment emergent.
|
0.00%
0/16 • Baseline to EOS Day 84
Adverse events summaries will only consider (TEAEs). TEAEs are defined as those AEs that occurred after dosing and those existing AEs that worsened during the study. If it cannot be determined whether the AE is treatment emergent due to an incomplete onset date, the AE will be considered to be treatment emergent.
|
|
Eye disorders
Eye infection
|
0.00%
0/17 • Baseline to EOS Day 84
Adverse events summaries will only consider (TEAEs). TEAEs are defined as those AEs that occurred after dosing and those existing AEs that worsened during the study. If it cannot be determined whether the AE is treatment emergent due to an incomplete onset date, the AE will be considered to be treatment emergent.
|
6.2%
1/16 • Baseline to EOS Day 84
Adverse events summaries will only consider (TEAEs). TEAEs are defined as those AEs that occurred after dosing and those existing AEs that worsened during the study. If it cannot be determined whether the AE is treatment emergent due to an incomplete onset date, the AE will be considered to be treatment emergent.
|
Additional Information
Susan Cutler, VP, Medical Affairs
Verrica Pharmaceuticals
Phone: 484-773-0898
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee PI is bound to terms and conditions of a Sponsored Clinical Trial Agreement which has strict confidentiality obligations running to Sponsor and broad provisions restricting PI's rights to publish or present any data or Study Results without Sponsor's express review consent and review.
- Publication restrictions are in place
Restriction type: OTHER