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A Study of A-101 Topical Solution Administered Twice a Week 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: NCT03278028
Recruitment Status : Completed
First Posted : September 11, 2017
Results First Posted : March 29, 2019
Last Update Posted : April 9, 2019
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 Wart
Interventions Drug: A-101 Topical Solution
Drug: A-101 Vehicle Solution
Enrollment 159
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Active Vehicle
Hide Arm/Group Description

A-101 Topical Solutions

A-101 Topical Solution: A-101 Topical Solution

Vehicle

A-101 Vehicle Solution: A-101 Vehicle Solution

Period Title: Overall Study
Started 81 78
Completed 77 76
Not Completed 4 2
Reason Not Completed
Lost to Follow-up             1             0
Withdrawal by Subject             3             1
Pregnancy             0             1
Arm/Group Title Active Vehicle Total
Hide Arm/Group Description

A-101 Topical Solution

A-101 Topical Solution: A-101 Topical Solution

Vehicle

A-101 Vehicle Solution: A-101 Vehicle Solution

Total of all reporting groups
Overall Number of Baseline Participants 81 78 159
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 81 participants 78 participants 159 participants
37.96  (18.09) 41.56  (17.42) 39.73  (17.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 81 participants 78 participants 159 participants
Female
48
  59.3%
43
  55.1%
91
  57.2%
Male
33
  40.7%
35
  44.9%
68
  42.8%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 81 participants 78 participants 159 participants
Hispanic or Latino
13
  16.0%
16
  20.5%
29
  18.2%
Not Hispanic or Latino
65
  80.2%
55
  70.5%
120
  75.5%
Unknown or Not Reported
3
   3.7%
7
   9.0%
10
   6.3%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 81 participants 78 participants 159 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
1
   1.2%
0
   0.0%
1
   0.6%
Native Hawaiian or Other Pacific Islander
1
   1.2%
1
   1.3%
2
   1.3%
Black or African American
1
   1.2%
4
   5.1%
5
   3.1%
White
78
  96.3%
70
  89.7%
148
  93.1%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
3
   3.8%
3
   1.9%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 81 participants 78 participants 159 participants
81 78 159
1.Primary Outcome
Title Physician's Wart Assessment
Hide Description

Physician's Wart Assessment Grade Descriptor 0 Clear: No visible wart. No further treatment is indicated.

  1. Near Clear: A visible wart that is less than 3 mm in maximal diameter (or length)
  2. A visible wart ≥ 3 mm and < 6 mm in maximal diameter (or length)
  3. A visible wart ≥ 6 mm in maximal diameter (or length)
Time Frame Day 57
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Hide Analysis Population Description
Per-Protocol (PP)
Arm/Group Title Active Vehicle
Hide Arm/Group Description:

A-101 Topical Solution

A-101 Topical Solution: A-101 Topical Solution

Vehicle

A-101 Vehicle Solution: A-101 Vehicle Solution

Overall Number of Participants Analyzed 79 78
Mean (Standard Deviation)
Unit of Measure: score on a scale
1.52  (1.06) 2.23  (0.66)
Time Frame 78 days; Treatment-emergent adverse events (TEAEs) had a start date on or after the date of Visit 2 (study day 1) and treatment-emergent serious adverse events had a start date on or after the date of Visit 1 (Screening). Collection continued through visit 11 (Day 78)
Adverse Event Reporting Description

An adverse event (AE) was any untoward medical occurrence in a patient or clinical investigation subject administered a study medication(s) and that did not necessarily have a causal relationship with the study medication.

Safety summaries by study medication group will include listings by study medication of adverse events incidences within each MedDRA System Organ Class, and changes from pre-application values in vital signs.

 
Arm/Group Title Active Vehicle
Hide Arm/Group Description

A-101 Topical Solution

A-101 Topical Solution: A-101 Topical Solution

Vehicle

A-101 Vehicle Solution: A-101 Vehicle Solution

All-Cause Mortality
Active Vehicle
Affected / at Risk (%) Affected / at Risk (%)
Total   0/81 (0.00%)      0/78 (0.00%)    
Hide Serious Adverse Events
Active Vehicle
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/81 (0.00%)      0/78 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Active Vehicle
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   28/81 (34.57%)      19/78 (24.36%)    
Ear and labyrinth disorders     
Tympanic Membrane Perforation  1  1/81 (1.23%)  1 0/78 (0.00%)  0
Gastrointestinal disorders     
Constipation  1  0/81 (0.00%)  0 2/78 (2.56%)  2
Diarrhoea  1  1/81 (1.23%)  1 0/78 (0.00%)  0
Irritable Bowel Syndrome  1  1/81 (1.23%)  1 0/78 (0.00%)  0
Vomiting  1  1/81 (1.23%)  1 0/78 (0.00%)  0
General disorders     
Application Site Pain  1  1/81 (1.23%)  1 0/78 (0.00%)  0
Immune system disorders     
Food Allergy  1  0/81 (0.00%)  0 1/78 (1.28%)  1
Seasonal Allergy  1  1/81 (1.23%)  1 1/78 (1.28%)  1
Infections and infestations     
Ear Infection  1  0/81 (0.00%)  0 1/78 (1.28%)  1
Eye Infection  1  0/81 (0.00%)  0 1/78 (1.28%)  1
Gastroenteritis Viral  1  2/81 (2.47%)  2 1/78 (1.28%)  1
Infection  1  1/81 (1.23%)  1 0/78 (0.00%)  0
Influenza  1  2/81 (2.47%)  2 0/78 (0.00%)  0
Localised Infection  1  0/81 (0.00%)  0 1/78 (1.28%)  1
Nasopharyngitis  1  5/81 (6.17%)  5 4/78 (5.13%)  4
Pneumonia  1  1/81 (1.23%)  1 0/78 (0.00%)  0
Post Operative Wound Infection  1  1/81 (1.23%)  1 0/78 (0.00%)  0
Salmonellosis  1  1/81 (1.23%)  1 0/78 (0.00%)  0
Sinusitis  1  0/81 (0.00%)  0 1/78 (1.28%)  1
Upper Respiratory Tract Infection  1  4/81 (4.94%)  4 4/78 (5.13%)  4
Urinary Tract Infection  1  0/81 (0.00%)  0 1/78 (1.28%)  1
Injury, poisoning and procedural complications     
Foot Fracture  1  0/81 (0.00%)  0 1/78 (1.28%)  1
Injury  1  2/81 (2.47%)  2 0/78 (0.00%)  0
Investigations     
Blood Lactate Dehydrogenase Increased  1  1/81 (1.23%)  1 0/78 (0.00%)  0
Hepatic Enzyme Increased  1  1/81 (1.23%)  1 0/78 (0.00%)  0
Liver Function Test Increased  1  1/81 (1.23%)  1 0/78 (0.00%)  0
Metabolism and nutrition disorders     
Electrolyte Imbalance  1  1/81 (1.23%)  1 0/78 (0.00%)  0
Hyperlipidaemia  1  0/81 (0.00%)  0 1/78 (1.28%)  1
Musculoskeletal and connective tissue disorders     
Arthralgia  1  1/81 (1.23%)  1 0/78 (0.00%)  0
Back Pain  1  0/81 (0.00%)  0 1/78 (1.28%)  1
Coccydynia  1  0/81 (0.00%)  0 1/78 (1.28%)  1
Neck Pain  1  0/81 (0.00%)  0 1/78 (1.28%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Squamous Cell Carcinoma of Head and Neck  1  0/81 (0.00%)  0 1/78 (1.28%)  1
Nervous system disorders     
Headache  1  2/81 (2.47%)  2 1/78 (1.28%)  1
Product Issues     
Device Dislocation  1  0/81 (0.00%)  0 1/78 (1.28%)  1
Reproductive system and breast disorders     
Ovarian Cyst Ruptured  1  1/81 (1.23%)  1 0/78 (0.00%)  0
Uterine Haemorrage  1  1/81 (1.23%)  1 0/78 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Asthma  1  0/81 (0.00%)  0 1/78 (1.28%)  1
Oropharyngeal Pain  1  1/81 (1.23%)  1 0/78 (0.00%)  0
Skin and subcutaneous tissue disorders     
Dermatitis Contact  1  1/81 (1.23%)  1 0/78 (0.00%)  0
Pain of Skin  1  1/81 (1.23%)  1 0/78 (0.00%)  0
Skin Exfoliation  1  1/81 (1.23%)  1 0/78 (0.00%)  0
Skin Hyperpigmentation  1  1/81 (1.23%)  1 0/78 (0.00%)  0
Skin Hypopigmentation  1  2/81 (2.47%)  2 0/78 (0.00%)  0
Vascular disorders     
Hypertension  1  2/81 (2.47%)  2 0/78 (0.00%)  0
1
Term from vocabulary, MedDRA (19.0)
Indicates events were collected by systematic assessment
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Executive Director, Clinical Operations
Organization: Aclaris Therapeutics
Phone: +1(484) 329-2144
EMail: jschnyder@aclaristx.com
Layout table for additonal information
Responsible Party: Aclaris Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT03278028    
Other Study ID Numbers: A-101-WART-203
First Submitted: August 18, 2017
First Posted: September 11, 2017
Results First Submitted: March 7, 2019
Results First Posted: March 29, 2019
Last Update Posted: April 9, 2019