Cantharidin Application in Molluscum Patients (CAMP-2)

• ClinicalTrials.gov Identifier: NCT03377803
• Recruitment Status: Completed
• First Posted: December 19, 2017
• Results First Posted: December 14, 2021
• Last Update Posted: December 14, 2021
• Sponsor: Verrica Pharmaceuticals Inc.
• Collaborators: Instat Consulting, Inc.; Paidion Research, Inc.; Database Integrations, Inc.
• Information provided by (Responsible Party): Verrica Pharmaceuticals Inc.

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Molluscum Contagiosum
• Interventions: Combination Product: VP-102 - Cantharidin, Topical Film Forming Solution; Combination Product: Placebo -Topical Film Forming Solution without VP-102
• Enrollment: 262

Participant Flow

Recruitment Details
Pre-assignment Details

Arm/Group Title	VP-102	Placebo
Arm/Group Description	VP-102 Film Forming Solution applied via a prefilled applicator to affected area every 21 days VP-102: VP-102 Active will be administered via the applicator to Molluscum lesions Applicator: Used to apply the topical film forming Active or Placebo to Molluscum.	Vehicle Film Forming Solution applied via a prefilled applicator to affected area every 21 days Placebo: Placebo to be applied via the applicator to Molluscum lesions Applicator: Used to apply the topical film forming Active or Placebo to Molluscum.
Period Title: Overall Study
Started	150	112
Completed	139	108
Not Completed	11	4

Baseline Characteristics

Arm/Group Title		VP-102	Placebo	Total
Arm/Group Description		VP-102 Film Forming Solution applied via a prefilled applicator to affected area every 21 days VP-102: VP-102 Active will be administered via the applicator to Molluscum lesions Applicator: Used to apply the topical film forming Active or Placebo to Molluscum.	Vehicle Film Forming Solution applied via a prefilled applicator to affected area every 21 days Placebo: Placebo to be applied via the applicator to Molluscum lesions Applicator: Used to apply the topical film forming Active or Placebo to Molluscum.	Total of all reporting groups
Overall Number of Baseline Participants		150	112	262
Baseline Analysis Population Description		ITT Population
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	150 participants	112 participants	262 participants
		7.4 (7.97)	7.3 (6.68)	7.4 (7.43)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	150 participants	112 participants	262 participants
	Female	69 46.0%	46 41.1%	115 43.9%
	Male	81 54.0%	66 58.9%	147 56.1%
Ethnicity (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	150 participants	112 participants	262 participants
	Hispanic or Latino	38 25.3%	23 20.5%	61 23.3%
	Not Hispanic or Latino	112 74.7%	87 77.7%	199 76.0%
	Unknown or Not Reported	0 0.0%	2 1.8%	2 0.8%
Race (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	150 participants	112 participants	262 participants
	American Indian or Alaska Native	0 0.0%	1 0.9%	1 0.4%
	Asian	2 1.3%	0 0.0%	2 0.8%
	Native Hawaiian or Other Pacific Islander	0 0.0%	0 0.0%	0 0.0%
	Black or African American	3 2.0%	3 2.7%	6 2.3%
	White	142 94.7%	104 92.9%	246 93.9%
	More than one race	0 0.0%	0 0.0%	0 0.0%
	Unknown or Not Reported	3 2.0%	4 3.6%	7 2.7%
Region of Enrollment; Measure Type: Number; Unit of measure: Participants
United States	Number Analyzed	150 participants	112 participants	262 participants
		150	112	262
Baseline Number of Molluscum Lesions [1]; Mean (Standard Deviation); Unit of measure: Molluscum lesions
	Number Analyzed	150 participants	112 participants	262 participants
		18.7 (22.93)	20.3 (19.29)	19.4 (21.43)
		[1] Measure Description: Number of all treatable molluscum lesions initially present.

Outcome Measures

1. Primary Outcome

Title	Percentage of Subjects Exhibiting Complete Clearance of All Treatable Molluscum Lesions (Baseline and New) on the Day 84 Visit (EOS)
Description	Percentage of subjects exhibiting complete clearance of all treatable molluscum lesions (baseline and new) on the Day 84 visit (EOS).
Time Frame	Day 1 (Baseline) compared to Day 84 (EOS)

Outcome Measure Data

Analysis Population Description

ITT Population

Arm/Group Title	VP-102	Placebo
Arm/Group Description:	VP-102 Film Forming Solution applied via a prefilled applicator to affected area every 21 days VP-102: VP-102 Active will be administered via the applicator to Molluscum lesions Applicator: Used to apply the topical film forming Active or Placebo to Molluscum.	Vehicle Film Forming Solution applied via a prefilled applicator to affected area every 21 days Placebo: Placebo to be applied via the applicator to Molluscum lesions Applicator: Used to apply the topical film forming Active or Placebo to Molluscum.
Overall Number of Participants Analyzed	150	112
Measure Type: Count of Participants; Unit of Measure: Participants
	81 54.0%	15 13.4%

2. Secondary Outcome

Title	Percentage of Subjects Exhibiting Complete Clearance of All Treatable Molluscum Lesions (Baseline and New) on the Day 63 Visit
Description	Percentage of subjects exhibiting complete clearance of all treatable molluscum lesions (baseline and new) on the Day 63 visit.
Time Frame	Day 1 (Baseline) compared to Day 63

Outcome Measure Data

Analysis Population Description

ITT Population

Arm/Group Title	VP-102	Placebo
Arm/Group Description:	VP-102 Film Forming Solution applied via a prefilled applicator to affected area every 21 days VP-102: VP-102 Active will be administered via the applicator to Molluscum lesions Applicator: Used to apply the topical film forming Active or Placebo to Molluscum.	Vehicle Film Forming Solution applied via a prefilled applicator to affected area every 21 days Placebo: Placebo to be applied via the applicator to Molluscum lesions Applicator: Used to apply the topical film forming Active or Placebo to Molluscum.
Overall Number of Participants Analyzed	150	112
Measure Type: Count of Participants; Unit of Measure: Participants
	42 28.0%	5 4.5%

3. Secondary Outcome

Title	Percentage of Subjects Exhibiting Complete Clearance of All Treatable Molluscum Lesions (Baseline and New) on the Day 42 Visit
Description	Percentage of subjects exhibiting complete clearance of all treatable molluscum lesions (baseline and new) on the Day 42 visit.
Time Frame	Day 1 (Baseline) compared to Day 42

Outcome Measure Data

Analysis Population Description

ITT Population

Arm/Group Title	VP-102	Placebo
Arm/Group Description:	VP-102 Film Forming Solution applied via a prefilled applicator to affected area every 21 days VP-102: VP-102 Active will be administered via the applicator to Molluscum lesions Applicator: Used to apply the topical film forming Active or Placebo to Molluscum.	Vehicle Film Forming Solution applied via a prefilled applicator to affected area every 21 days Placebo: Placebo to be applied via the applicator to Molluscum lesions Applicator: Used to apply the topical film forming Active or Placebo to Molluscum.
Overall Number of Participants Analyzed	150	112
Measure Type: Count of Participants; Unit of Measure: Participants
	19 12.7%	4 3.6%

4. Secondary Outcome

Title	Percentage of Subjects Exhibiting Complete Clearance of All Treatable Molluscum Lesions (Baseline and New) on the Day 21 Visit
Description	Percentage of subjects exhibiting complete clearance of all treatable molluscum lesions (baseline and new) on the Day 21 visit.
Time Frame	Day 1 (Baseline) compared to Day 21

Outcome Measure Data

Analysis Population Description

ITT Population

Arm/Group Title	VP-102	Placebo
Arm/Group Description:	VP-102 Film Forming Solution applied via a prefilled applicator to affected area every 21 days VP-102: VP-102 Active will be administered via the applicator to Molluscum lesions Applicator: Used to apply the topical film forming Active or Placebo to Molluscum.	Vehicle Film Forming Solution applied via a prefilled applicator to affected area every 21 days Placebo: Placebo to be applied via the applicator to Molluscum lesions Applicator: Used to apply the topical film forming Active or Placebo to Molluscum.
Overall Number of Participants Analyzed	150	112
Measure Type: Count of Participants; Unit of Measure: Participants
	8 5.3%	2 1.8%

5. Other Pre-specified Outcome

Title	Change From Baseline of the Composite Score From the Children's Dermatology Life Quality Index (CDLQI) Assessment at the EOS Visit to Measure the Quality of Life and Impact of Skin Disease in the Subset of Subjects 4 -16 Years of Age
Description	Change from Baseline to EOS Day 84 of the Composite Score From the Children's Dermatology Life Quality Index (CDLQI) Assessment at the EOS Visit to Measure the Quality of Life and Impact of Skin Disease in the Subset of Subjects 4 -16 Years of Age. 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 Larger composite CDLQI scores indicate skin condition is having more effect on subjects' lives (worse outcome).
Time Frame	Day 1 (Baseline), 21, 42, 63 and Day 84 (EOS)

Outcome Measure Data

Analysis Population Description

ITT Population (Subjects 4-16 years of age)

Arm/Group Title	VP-102	Placebo
Arm/Group Description:	VP-102 Film Forming Solution applied via a prefilled applicator to affected area every 21 days VP-102: VP-102 Active will be administered via the applicator to Molluscum lesions Applicator: Used to apply the topical film forming Active or Placebo to Molluscum.	Vehicle Film Forming Solution applied via a prefilled applicator to affected area every 21 days Placebo: Placebo to be applied via the applicator to Molluscum lesions Applicator: Used to apply the topical film forming Active or Placebo to Molluscum.
Overall Number of Participants Analyzed	113	84
Mean (Standard Deviation); Unit of Measure: score on a scale
Day 21	-1.0 (3.31)	-1.2 (3.17)
Day 42	-1.5 (3.20)	-1.4 (2.82)
Day 63	-2.0 (3.28)	-1.6 (3.04)
Day 84 (EOS)	-2.1 (3.34)	-1.9 (3.35)

6. Other Pre-specified Outcome

Title	Percent Change of All Treatable Molluscum Lesions (Baseline and New) From Baseline at the EOS Visit
Description	Percent change of all treatable molluscum lesions (baseline and new) from baseline at the EOS visit.
Time Frame	Day 1 (Baseline) compared to Day 84 (EOS)

Outcome Measure Data

Analysis Population Description

ITT Population

Arm/Group Title	VP-102	Placebo
Arm/Group Description:	VP-102 Film Forming Solution applied via a prefilled applicator to affected area every 21 days VP-102: VP-102 Active will be administered via the applicator to Molluscum lesions Applicator: Used to apply the topical film forming Active or Placebo to Molluscum.	Vehicle Film Forming Solution applied via a prefilled applicator to affected area every 21 days Placebo: Placebo to be applied via the applicator to Molluscum lesions Applicator: Used to apply the topical film forming Active or Placebo to Molluscum.
Overall Number of Participants Analyzed	150	112
Mean (Standard Deviation); Unit of Measure: percentage change from Baseline
	-83.3 (43.13)	-19.1 (108.38)

7. Other Pre-specified Outcome

Title	Change From Baseline in the Number of Treatable Molluscum Lesions (Baseline and New) at the EOS Visit
Description	Change from baseline in the number of treatable molluscum lesions (baseline and new) at the EOS visit.
Time Frame	Day 1 (Baseline) compared to Day 84 (EOS)

Outcome Measure Data

Analysis Population Description

ITT Population

Arm/Group Title	VP-102	Placebo
Arm/Group Description:	VP-102 Film Forming Solution applied via a prefilled applicator to affected area every 21 days VP-102: VP-102 Active will be administered via the applicator to Molluscum lesions Applicator: Used to apply the topical film forming Active or Placebo to Molluscum.	Vehicle Film Forming Solution applied via a prefilled applicator to affected area every 21 days Placebo: Placebo to be applied via the applicator to Molluscum lesions Applicator: Used to apply the topical film forming Active or Placebo to Molluscum.
Overall Number of Participants Analyzed	150	112
Mean (Standard Deviation); Unit of Measure: change in wart count from baseline
	-17.1 (22.87)	-10.9 (20.14)

8. Other Pre-specified Outcome

Title	Percentage of Subjects Exhibiting a 75% or Greater Reduction of All Treatable Molluscum Lesions (Baseline and New) at the EOS Visit
Description	Percentage of subjects exhibiting a 75% or greater reduction of all treatable molluscum lesions (baseline and new) at the EOS visit.
Time Frame	Day 1 (Baseline) compared to Day 84(EOS)

Outcome Measure Data

Analysis Population Description

ITT Population

Arm/Group Title	VP-102	Placebo
Arm/Group Description:	VP-102 Film Forming Solution applied via a prefilled applicator to affected area every 21 days VP-102: VP-102 Active will be administered via the applicator to Molluscum lesions Applicator: Used to apply the topical film forming Active or Placebo to Molluscum.	Vehicle Film Forming Solution applied via a prefilled applicator to affected area every 21 days Placebo: Placebo to be applied via the applicator to Molluscum lesions Applicator: Used to apply the topical film forming Active or Placebo to Molluscum.
Overall Number of Participants Analyzed	150	112
Measure Type: Count of Participants; Unit of Measure: Participants
	122 81.3%	40 35.7%

9. Other Pre-specified Outcome

Title	Percentage of Subjects Exhibiting a 90% or Greater Reduction of All Treatable Molluscum Lesions (Baseline and New) at the EOS Visit
Description	Percentage of subjects exhibiting a 90% or greater reduction of all treatable molluscum lesions (baseline and new) at the EOS visit.
Time Frame	Day 1 (Baseline) compared to Day 84 (EOS)

Outcome Measure Data

Analysis Population Description

ITT Population

Arm/Group Title	VP-102	Placebo
Arm/Group Description:	VP-102 Film Forming Solution applied via a prefilled applicator to affected area every 21 days VP-102: VP-102 Active will be administered via the applicator to Molluscum lesions Applicator: Used to apply the topical film forming Active or Placebo to Molluscum.	Vehicle Film Forming Solution applied via a prefilled applicator to affected area every 21 days Placebo: Placebo to be applied via the applicator to Molluscum lesions Applicator: Used to apply the topical film forming Active or Placebo to Molluscum.
Overall Number of Participants Analyzed	150	112
Measure Type: Count of Participants; Unit of Measure: Participants
	105 70.0%	31 27.7%

10. Other Pre-specified Outcome

Title	Subject Reported Spread to Household Members as Measured by Any New Occurrence of Molluscum in Household Members of Subject
Description	Subject reported spread to household members as measured by any new occurrence of molluscum in household members of subject.
Time Frame	Days 1, 21, 42, 63 and 84 (EOS).

Outcome Measure Data

Analysis Population Description

ITT Population

Arm/Group Title	VP-102	Placebo
Arm/Group Description:	VP-102 Film Forming Solution applied via a prefilled applicator to affected area every 21 days VP-102: VP-102 Active will be administered via the applicator to Molluscum lesions Applicator: Used to apply the topical film forming Active or Placebo to Molluscum.	Vehicle Film Forming Solution applied via a prefilled applicator to affected area every 21 days Placebo: Placebo to be applied via the applicator to Molluscum lesions Applicator: Used to apply the topical film forming Active or Placebo to Molluscum.
Overall Number of Participants Analyzed	146	109
Measure Type: Count of Participants; Unit of Measure: Participants
	10 6.8%	7 6.4%

Adverse Events

Time Frame	Baseline Visit to EOS Visit 84 Days (12 weeks)
Adverse Event Reporting Description	Only TEAEs were to be considered.
Arm/Group Title	VP-102	Placebo
Arm/Group Description	VP-102 Film Forming Solution applied via a prefilled applicator to affected area every 21 days VP-102: VP-102 Active will be administered via the applicator to Molluscum lesions Applicator: Used to apply the topical film forming Active or Placebo to Molluscum.	Vehicle Film Forming Solution applied via a prefilled applicator to affected area every 21 days Placebo: Placebo to be applied via the applicator to Molluscum lesions Applicator: Used to apply the topical film forming Active or Placebo to Molluscum.
All-Cause Mortality
	VP-102	Placebo
	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/150 (0.00%)	0/112 (0.00%)
Serious Adverse Events
	VP-102	Placebo
	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/150 (0.00%)	0/112 (0.00%)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	VP-102	Placebo
	Affected / at Risk (%)	Affected / at Risk (%)
Total	143/150 (95.33%)	74/112 (66.07%)
Injury, poisoning and procedural complications
Application site Pain † 1 [1]	83/150 (55.33%)	16/112 (14.29%)
Application site oedema † 1 [2]	8/150 (5.33%)	4/112 (3.57%)
Skin and subcutaneous tissue disorders
Application site vesicles † 1 [3]	141/150 (94.00%)	34/112 (30.36%)
Application site scab † 1 [4]	85/150 (56.67%)	22/112 (19.64%)
Application site pruritus † 1 [5]	65/150 (43.33%)	37/112 (33.04%)
Application site erythema † 1 [6]	70/150 (46.67%)	28/112 (25.00%)
Application site dryness † 1 [7]	39/150 (26.00%)	20/112 (17.86%)
Application site discolouration † 1 [8]	46/150 (30.67%)	9/112 (8.04%)
Application site erosion † 1 [9]	12/150 (8.00%)	0/112 (0.00%)
1 Term from vocabulary, MedDRA (20.0); † Indicates events were collected by systematic assessment; [1] Application site Pain; [2] Application site oedema; [3] Application site vesicles; [4] Application site scab; [5] Application site pruritus; [6] Application site erythema; [7] Application site dryness; [8] Application site discolouration; [9] Application site erosion

Limitations and Caveats

[Not Specified]

More Information

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

• 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):

Eichenfield LF, Kwong P, Gonzalez ME, Yan A, D'Arnaud P, Burnett P, Olivadoti M. Safety and Efficacy of VP-102 (Cantharidin, 0.7% w/v) in Molluscum Contagiosum by Body Region: Post hoc Pooled Analyses from Two Phase III Randomized Trials. J Clin Aesthet Dermatol. 2021 Oct;14(10):42-47.

Eichenfield LF, Siegfried E, Kwong P, McBride M, Rieger J, Glover D, Willson C, Davidson M, Burnett P, Olivadoti M. Pooled Results of Two Randomized Phase III Trials Evaluating VP-102, a Drug-Device Combination Product Containing Cantharidin 0.7% (w/v) for the Treatment of Molluscum Contagiosum. Am J Clin Dermatol. 2021 Mar;22(2):257-265. doi: 10.1007/s40257-020-00570-8. Epub 2021 Feb 18.

Eichenfield LF, McFalda W, Brabec B, Siegfried E, Kwong P, McBride M, Rieger J, Willson C, Davidson M, Burnett P. Safety and Efficacy of VP-102, a Proprietary, Drug-Device Combination Product Containing Cantharidin, 0.7% (w/v), in Children and Adults With Molluscum Contagiosum: Two Phase 3 Randomized Clinical Trials. JAMA Dermatol. 2020 Dec 1;156(12):1315-1323. doi: 10.1001/jamadermatol.2020.3238.

• Responsible Party: Verrica Pharmaceuticals Inc.
• ClinicalTrials.gov Identifier: NCT03377803
• Other Study ID Numbers: VP-102-102
• First Submitted: December 13, 2017
• First Posted: December 19, 2017
• Results First Submitted: October 12, 2021
• Results First Posted: December 14, 2021
• Last Update Posted: December 14, 2021