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Trial record 2 of 27 for:    aclaris

A Study of A-101 Solution in Subjects With Common Warts.

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: NCT02669862
Recruitment Status : Completed
First Posted : February 1, 2016
Results First Posted : December 7, 2018
Last Update Posted : December 7, 2018
Sponsor:
Information provided by (Responsible Party):
Aclaris Therapeutics, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Common Warts
Interventions Drug: A-101 Solution 40
Drug: A-101 Solution 45
Drug: Vehicle Solution
Enrollment 98
Recruitment Details  
Pre-assignment Details  
Arm/Group Title A-101 Solution 40 A-101 Solution 45 Vehicle Solution
Hide Arm/Group Description

A-101 Solution 40% administered once per week

A-101 Solution 40

A-101 Solution 45% administered once per week

A-101 Solution 45

Vehicle Solution administered once per week

Vehicle Solution

Period Title: Overall Study
Started 33 34 31
Completed [1] 31 29 26
Not Completed 2 5 5
Reason Not Completed
Lost to Follow-up             0             2             1
Withdrawal by Subject             2             2             3
moved             0             1             0
Protocol Violation             0             0             1
[1]
Patients completing visit 10 according to protocol
Arm/Group Title A-101 Solution 40 A-101 Solution 45 Vehicle Solution Total
Hide Arm/Group Description

A-101 Solution 40% administered once per week

A-101 Solution 40

A-101 Solution 45% administered once per week

A-101 Solution 45

Vehicle Solution administered once per week

Vehicle Solution

Total of all reporting groups
Overall Number of Baseline Participants 33 34 31 98
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 33 participants 34 participants 31 participants 98 participants
41.3  (16.40) 41.2  (14.11) 39.5  (13.37) 40.7  (14.57)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 33 participants 34 participants 31 participants 98 participants
Female
14
  42.4%
21
  61.8%
17
  54.8%
52
  53.1%
Male
19
  57.6%
13
  38.2%
14
  45.2%
46
  46.9%
Ethnicity (NIH/OMB)   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 33 participants 34 participants 31 participants 98 participants
Hispanic or Latino
3
   9.1%
6
  17.6%
2
   6.5%
11
  11.2%
Not Hispanic or Latino
27
  81.8%
28
  82.4%
26
  83.9%
81
  82.7%
Unknown or Not Reported
3
   9.1%
0
   0.0%
3
   9.7%
6
   6.1%
[1]
Measure Analysis Population Description: Percentages are based on the number of randomized subjects within each treatment group.
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 33 participants 34 participants 31 participants 98 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
1
   3.2%
1
   1.0%
Black or African American
3
   9.1%
2
   5.9%
3
   9.7%
8
   8.2%
White
30
  90.9%
32
  94.1%
27
  87.1%
89
  90.8%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 33 participants 34 participants 31 participants 98 participants
33 34 31 98
1.Primary Outcome
Title Efficacy Based on Mean Change in Physician Wart Assessment Over Time
Hide Description The primary effectiveness will consist of the mean change from Visit 2 to Visit 10 in Physician Wart Assessment (PWA) performed using Analysis of Covariance (ANCOVA) with Visit 2 PWA as the covariate. Physician Wart Analysis is a measurement scale from 0 to 3 that evaluates the wart with 0 being clear and 3 being clinically diagnosable wart that is raised, with an obviously rough surface.
Time Frame 57 Days
Hide Outcome Measure Data
Hide Analysis Population Description
Number of participants analyzed is the number of participants completing the protocol through visit 10.
Arm/Group Title A-101 Solution 40 A-101 Solution 45 Vehicle Solution
Hide Arm/Group Description:

A-101 Solution 40% administered once per week

A-101 Solution 40

A-101 Solution 45% administered once per week

A-101 Solution 45

Vehicle Solution administered once per week

Vehicle Solution

Overall Number of Participants Analyzed 32 31 27
Mean (Standard Deviation)
Unit of Measure: units on a scale
-0.38  (0.75) -1.00  (0.97) -0.44  (0.85)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection A-101 Solution 40, Vehicle Solution
Comments

In this table Study Day 01 / Visit 2 has been considered as Baseline visit for calculating mean and mean change.

PVal*- ANCOVA used for calculating P-value by comparing Vehicle against each Active treatment group using baseline values as the covariate.

Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.555
Comments [Not Specified]
Method ANCOVA
Comments Baseline values were the covariate
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection A-101 Solution 45, Vehicle Solution
Comments

In this table Study Day 01 / Visit 2 has been considered as Baseline visit for calculating mean and mean change.

PVal*- ANCOVA used for calculating P-value by comparing Vehicle against each Active treatment group using baseline values as the covariate.

Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.009
Comments PVal*- ANCOVA used for calculating P-value by comparing Vehicle against each Active treatment group using baseline values as the covariate. No adjustments for multiple comparisons.
Method ANCOVA
Comments [Not Specified]
2.Secondary Outcome
Title Durability of Response - Percentage of Participants That Were Clear at Visit 10 That Are Still Clear at Visit 13
Hide Description Percentage of subjects whose target wart was clear at Visit 10 and who remained clear at Visit 13 for active treatment groups
Time Frame visit 10 to visit 13
Hide Outcome Measure Data
Hide Analysis Population Description
Only the number of participants clear at visit 10 are compared to the number of participants clear at visit 13 to get the percentage clear for active treatment groups only.
Arm/Group Title A-101 Solution 40 A-101 Solution 45
Hide Arm/Group Description:

A-101 Solution 40% administered once per week

A-101 Solution 40

A-101 Solution 45% administered once per week

A-101 Solution 45

Overall Number of Participants Analyzed 1 8
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage participants
100
87.50
(64.58 to 99.99)
3.Secondary Outcome
Title PWA Responder
Hide Description The percentage of participants who were responders with the target wart judged to be clear (PWA = 0) at Visit 10.
Time Frame Day 57
Hide Outcome Measure Data
Hide Analysis Population Description
PP population = participants completing protocol to visit 10
Arm/Group Title A-101 Solution 40 A-101 Solution 45 Vehicle Solution
Hide Arm/Group Description:
A-101 Solution 40% administered once per week
A-101 Solution 45% administered once per week
Vehicle Solution administered once per week
Overall Number of Participants Analyzed 32 31 27
Measure Type: Number
Unit of Measure: percentage of responders
3.13 25.81 3.70
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection A-101 Solution 40, Vehicle Solution
Comments PVal*- Chi-Square test used for calculating P-value by comparing Vehicle against each Active treatment group
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9313
Comments Not adjusted for multiple comparisons
Method Chi-squared
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection A-101 Solution 45, Vehicle Solution
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0236
Comments Not adjusted for multiple comparisons
Method Chi-squared
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title A-101 Solution 40 A-101 Solution 45 Vehicle Solution
Hide Arm/Group Description

A-101 Solution 40% administered once per week

A-101 Solution 40

A-101 Solution 45% administered once per week

A-101 Solution 45

Vehicle Solution administered once per week

Vehicle Solution

All-Cause Mortality
A-101 Solution 40 A-101 Solution 45 Vehicle Solution
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/33 (0.00%)      0/34 (0.00%)      0/31 (0.00%)    
Hide Serious Adverse Events
A-101 Solution 40 A-101 Solution 45 Vehicle Solution
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/33 (0.00%)      0/34 (0.00%)      0/31 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
A-101 Solution 40 A-101 Solution 45 Vehicle Solution
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   8/33 (24.24%)      6/34 (17.65%)      10/31 (32.26%)    
General disorders       
Application site pain  [1]  2/33 (6.06%)  2 0/34 (0.00%)  0 0/31 (0.00%)  0
Immune system disorders       
Seasonal allergy   1/33 (3.03%)  1 3/34 (8.82%)  3 2/31 (6.45%)  2
Infections and infestations       
Upper respiratory tract infection   4/33 (12.12%)  4 0/34 (0.00%)  0 2/31 (6.45%)  2
Nervous system disorders       
Headache   1/33 (3.03%)  1 1/34 (2.94%)  1 4/31 (12.90%)  4
Migraine   0/33 (0.00%)  0 0/34 (0.00%)  0 2/31 (6.45%)  2
Psychiatric disorders       
Anxiety   0/33 (0.00%)  0 2/34 (5.88%)  2 0/31 (0.00%)  0
Indicates events were collected by systematic assessment
[1]
Administration site conditions
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.
The Institution and Investigator agree not to publish the results of this study without the prior written consent of Sponsor.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Judy Schnyder, Senior Director of Clinical Operations
Organization: Aclaris Therapeutics, Inc.
Phone: 484-329-2144
EMail: jschnyder@aclaristx.com
Layout table for additonal information
Responsible Party: Aclaris Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT02669862    
Other Study ID Numbers: A-101-WART-201
First Submitted: January 28, 2016
First Posted: February 1, 2016
Results First Submitted: April 4, 2018
Results First Posted: December 7, 2018
Last Update Posted: December 7, 2018