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Evaluation of Systemic Exposure to VP-102 in Subjects With Molluscum Contagiosum.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03186378
Recruitment Status : Completed
First Posted : June 14, 2017
Results First Posted : August 9, 2021
Last Update Posted : August 11, 2021
Sponsor:
Collaborators:
Paidion Research, Inc.
Database Integrations, Inc.
Cato Research
Instat services
Information provided by (Responsible Party):
Verrica Pharmaceuticals Inc.

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Molluscum Contagiosum
Intervention Combination Product: VP-102 with applicator
Enrollment 33
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Exposure Group Standard Group
Hide Arm/Group Description

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.

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.
Period Title: Overall Study
Started 17 16
Completed 16 16
Not Completed 1 0
Reason Not Completed
Lost to Follow-up             1             0
Arm/Group Title Exposure Group Standard Group Total
Hide Arm/Group Description

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.

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 of all reporting groups
Overall Number of Baseline Participants 17 16 33
Hide Baseline Analysis Population Description
ITT Population
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 17 participants 16 participants 33 participants
6.6  (3.45) 6.8  (3.15) 6.7  (3.26)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants 16 participants 33 participants
Female
7
  41.2%
8
  50.0%
15
  45.5%
Male
10
  58.8%
8
  50.0%
18
  54.5%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants 16 participants 33 participants
Hispanic or Latino
0
   0.0%
2
  12.5%
2
   6.1%
Not Hispanic or Latino
17
 100.0%
14
  87.5%
31
  93.9%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants 16 participants 33 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
1
   5.9%
2
  12.5%
3
   9.1%
White
16
  94.1%
14
  87.5%
30
  90.9%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 17 participants 16 participants 33 participants
17
 100.0%
16
 100.0%
33
 100.0%
Baseline Number of Molluscum Lesions  
Mean (Standard Deviation)
Unit of measure:  Molluscum lesions
Number Analyzed 17 participants 16 participants 33 participants
47.4  (25.69) 11.6  (6.33) 30.0  (26.07)
1.Primary Outcome
Title 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.
Hide Description 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.
Time Frame 24 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Exposure Group
Hide Arm/Group Description:

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.
Overall Number of Participants Analyzed 16
Measure Type: Count of Participants
Unit of Measure: Participants
Any Concentration Level of VP-102 above LLOQ (2.5ng/ml) Pre-treatment Yes
0
   0.0%
No
16
 100.0%
Any Concentration Level of VP-102 above LLOQ (2.5ng/ml) 2hr Post Treatment Yes
1
   6.3%
No
15
  93.8%
Any Concentration Level of VP-102 above LLOQ (2.5ng/ml) 6hr Post Treatment Yes
0
   0.0%
No
16
 100.0%
Any Concentration Level of VP-102 above LLOQ (2.5ng/ml) 24hr Post Treatment Yes
0
   0.0%
No
16
 100.0%
2.Secondary Outcome
Title Measurement of Efficacy - Complete Clearance
Hide Description Proportion of subjects exhibiting complete clearance of all treated molluscum lesions (baseline and new) on or before Week 12 (EOS).
Time Frame Baseline through EOS Day 84
Hide Outcome Measure Data
Hide Analysis Population Description
Complete Clearance of Molluscum Lesions - Completer Population
Arm/Group Title Exposure Group Standard Group
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 16 16
Measure Type: Count of Participants
Unit of Measure: Participants
Complete Clearance Day 21
0
   0.0%
3
  18.8%
Complete Clearance Day 42
2
  12.5%
7
  43.8%
Complete Clearance Day 63
4
  25.0%
9
  56.3%
Complete Clearance EOS Day 84
6
  37.5%
10
  62.5%
3.Other Pre-specified Outcome
Title Proportion of Subjects Exhibiting a 90% or Greater Reduction of All Treated Molluscum Lesions (Baseline and New) at the EOS Visit.
Hide Description Summaries of >=90% clearance by visit include clearance at that visit or any earlier visit (cumulative) baseline and ew at the EOS visit.
Time Frame Baseline to EOS Day 84
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Exposure Group Standard Group
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 17 16
Measure Type: Count of Participants
Unit of Measure: Participants
>=90% Clearance Day 21
0
   0.0%
3
  18.8%
>=90% Clearance Day 42
5
  29.4%
7
  43.8%
>=90% Clearance Day 63
8
  47.1%
10
  62.5%
>=90% Clearance Day 84
12
  70.6%
13
  81.3%
4.Other Pre-specified Outcome
Title Percent Reduction of Treated Molluscum Lesions From Baseline at the EOS Visit.
Hide Description Percent reduction of treated molluscum lesions from Baseline Visit at the EOS visit.
Time Frame Baseline to EOS Day 84
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Exposure Group Standard Group
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 16 16
Mean (Standard Deviation)
Unit of Measure: percentage change from Baseline
-87.8  (21.25) -93.0  (12.93)
5.Other Pre-specified Outcome
Title Change From Baseline in the Number of Treated Molluscum Lesions at the EOS Visit.
Hide Description Molluscum Lesions- Change from Baseline visit in the number of treated molluscum lesions at the EOS Day 84 visit
Time Frame Baseline to EOS Day 84
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Exposure Group Standard Group
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 16 16
Mean (Standard Deviation)
Unit of Measure: change in wart count
-39.3  (21.98) -10.7  (6.16)
6.Other Pre-specified Outcome
Title Change From Baseline in Quality of Life and Impact of Skin Disease as Measured by CDLQI Assessment
Hide Description

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
Time Frame Baseline to EOS Day 84
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Exposure Group Standard Group
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 17 16
Mean (Standard Deviation)
Unit of Measure: units on a scale change from Baseline
2.71  (2.801) 2.44  (4.115)
7.Other Pre-specified Outcome
Title Spread to Siblings as Measured by Any New Occurrence of Molluscum in Siblings of the Subject.
Hide Description Spread of molluscum to siblings as measured by any new occurrence of molluscum in siblings of the subject.
Time Frame Baseline to EOS Day 84
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Exposure Group Standard Group
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 17 16
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
Time Frame Baseline to EOS Day 84
Adverse Event Reporting Description 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.
 
Arm/Group Title Exposure Group Standard Group
Hide Arm/Group Description

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.

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.
All-Cause Mortality
Exposure Group Standard Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/17 (0.00%)   0/16 (0.00%) 
Hide Serious Adverse Events
Exposure Group Standard Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/17 (0.00%)   0/16 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Exposure Group Standard Group
Affected / at Risk (%) Affected / at Risk (%)
Total   16/17 (94.12%)   13/16 (81.25%) 
Eye disorders     
Eye infection † 1  0/17 (0.00%)  1/16 (6.25%) 
Gastrointestinal disorders     
Vomiting † 1  1/17 (5.88%)  3/16 (18.75%) 
Diarrhoea † 1  1/17 (5.88%)  1/16 (6.25%) 
Gastrooesophageal reflux disease † 1  0/17 (0.00%)  1/16 (6.25%) 
General disorders     
Pain † 1 [1]  11/17 (64.71%)  8/16 (50.00%) 
Burning Sensation † 1 [1]  1/17 (5.88%)  0/16 (0.00%) 
Pyrexia † 1 [1]  1/17 (5.88%)  0/16 (0.00%) 
Immune system disorders     
Asthma † 1  1/17 (5.88%)  0/16 (0.00%) 
Hypersensitivity † 1  1/17 (5.88%)  0/16 (0.00%) 
Infections and infestations     
Pharyngitis † 1  0/17 (0.00%)  1/16 (6.25%) 
Tinea infection † 1  1/17 (5.88%)  0/16 (0.00%) 
Upper respiratory tract infection † 1  1/17 (5.88%)  0/16 (0.00%) 
Injury, poisoning and procedural complications     
Administration site pain † 1  1/17 (5.88%)  0/16 (0.00%) 
Head injury † 1  1/17 (5.88%)  0/16 (0.00%) 
Nervous system disorders     
Headache † 1  2/17 (11.76%)  3/16 (18.75%) 
Psychiatric disorders     
Adjustment disorder † 1  1/17 (5.88%)  0/16 (0.00%) 
Lethargy † 1  1/17 (5.88%)  0/16 (0.00%) 
Tic † 1  1/17 (5.88%)  0/16 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Cough † 1  3/17 (17.65%)  3/16 (18.75%) 
Oropharyngeal pain † 1  1/17 (5.88%)  2/16 (12.50%) 
Rhinorrhoea † 1  2/17 (11.76%)  1/16 (6.25%) 
Epistaxis † 1  0/17 (0.00%)  1/16 (6.25%) 
Influenza † 1  1/17 (5.88%)  0/16 (0.00%) 
Paranasal sinus hypersecretion † 1  0/17 (0.00%)  1/16 (6.25%) 
Respiratory tract congestion † 1  0/17 (0.00%)  1/16 (6.25%) 
Wheezing † 1  1/17 (5.88%)  0/16 (0.00%) 
Skin and subcutaneous tissue disorders     
Scar † 1  3/17 (17.65%)  1/16 (6.25%) 
Application site vesicles † 1  1/17 (5.88%)  0/16 (0.00%) 
Cellulitis † 1  1/17 (5.88%)  0/16 (0.00%) 
Impetigo † 1  1/17 (5.88%)  0/16 (0.00%) 
Rash † 1  1/17 (5.88%)  0/16 (0.00%) 
Subcutaneous abscess † 1  1/17 (5.88%)  0/16 (0.00%) 
1
Term from vocabulary, MedDRA (19.1)
†
Indicates events were collected by systematic assessment
[1]
General disorders and administration site conditions
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Susan Cutler, VP, Medical Affairs
Organization: Verrica Pharmaceuticals
Phone: 484-773-0898
EMail: scutler@verrica.com
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Verrica Pharmaceuticals Inc.
ClinicalTrials.gov Identifier: NCT03186378    
Other Study ID Numbers: VP-102-103
First Submitted: June 12, 2017
First Posted: June 14, 2017
Results First Submitted: June 22, 2021
Results First Posted: August 9, 2021
Last Update Posted: August 11, 2021