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Trial record 1 of 14 for:    "Keratosis seborrheic"
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A Study of A-101 Solution 40% in Subjects With Seborrheic Keratosis.

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ClinicalTrials.gov Identifier: NCT02667236
Recruitment Status : Completed
First Posted : January 28, 2016
Results First Posted : November 13, 2017
Last Update Posted : February 6, 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 Seborrheic Keratosis
Interventions Drug: A-101 Solution
Other: Vehicle Solution
Enrollment 450
Recruitment Details  
Pre-assignment Details  
Arm/Group Title A-101 Solution Vehicle Solution
Hide Arm/Group Description

A-101 Solution 40% applied topically

A-101 Solution: Active Drug

Vehicle Solution applied topically

Vehicle Solution: Placebo

Period Title: Overall Study
Started 223 227
Completed 220 226
Not Completed 3 1
Reason Not Completed
Adverse Event             1             1
Withdrawal by Subject             2             0
Arm/Group Title A-101 Solution Vehicle Solution Total
Hide Arm/Group Description

A-101 Solution 40% applied topically

A-101 Solution: Active Drug

Vehicle Solution applied topically

Vehicle Solution: Placebo

Total of all reporting groups
Overall Number of Baseline Participants 223 227 450
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 223 participants 227 participants 450 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
72
  32.3%
55
  24.2%
127
  28.2%
>=65 years
151
  67.7%
172
  75.8%
323
  71.8%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 223 participants 227 participants 450 participants
68.3  (8.42) 69.1  (8.71) 68.7  (8.57)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 223 participants 227 participants 450 participants
Female
138
  61.9%
126
  55.5%
264
  58.7%
Male
85
  38.1%
101
  44.5%
186
  41.3%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 223 participants 227 participants 450 participants
Hispanic or Latino
5
   2.2%
5
   2.2%
10
   2.2%
Not Hispanic or Latino
214
  96.0%
216
  95.2%
430
  95.6%
Unknown or Not Reported
4
   1.8%
6
   2.6%
10
   2.2%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 223 participants 227 participants 450 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
2
   0.9%
4
   1.8%
6
   1.3%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
1
   0.4%
1
   0.4%
2
   0.4%
White
219
  98.2%
221
  97.4%
440
  97.8%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
1
   0.4%
1
   0.4%
2
   0.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 223 participants 227 participants 450 participants
223 227 450
1.Primary Outcome
Title Proportion of Subjects With Target Lesion Clearance as Assessed by the Physician Lesion Assessment
Hide Description Proportion of subjects for whom all target lesions were judged to be clear on the Physician Lesion Assessment Scale (PLA=0) at Visit 8. The PLA Scale is a 4 point scale used by the investigator to assess each subject's target SK Lesion.
Time Frame Day 106 of the study
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population; all randomized subjects
Arm/Group Title A-101 Solution Vehicle Solution
Hide Arm/Group Description:

A-101 Solution 40% applied topically

A-101 Solution: Active Drug

Vehicle Solution applied topically

Vehicle Solution: Placebo

Overall Number of Participants Analyzed 223 227
Measure Type: Count of Participants
Unit of Measure: Participants
9
   4.0%
0
   0.0%
2.Secondary Outcome
Title Proportion of Subjects With 3 of 4 Target Lesion Clearance
Hide Description Proportion of Subjects for whom at least 3 of 4 target lesions were judged to be clear on the Physician Lesion Assessment (PLA=0) at Visit 8
Time Frame Day 106 of the study
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population; all randomized subjects
Arm/Group Title A-101 Solution Vehicle Solution
Hide Arm/Group Description:

A-101 Solution 40% applied topically

A-101 Solution: Active Drug

Vehicle Solution applied topically

Vehicle Solution: Placebo

Overall Number of Participants Analyzed 223 227
Measure Type: Count of Participants
Unit of Measure: Participants
30
  13.5%
0
   0.0%
Time Frame Adverse events were collected from V2 (Day 1) through V8 (Day 106)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title A-101 Solution Vehicle Solution
Hide Arm/Group Description

A-101 Solution 40% applied topically

A-101 Solution: Active Drug

Vehicle Solution applied topically

Vehicle Solution: Placebo

All-Cause Mortality
A-101 Solution Vehicle Solution
Affected / at Risk (%) Affected / at Risk (%)
Total   0/223 (0.00%)      0/227 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
A-101 Solution Vehicle Solution
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/223 (1.79%)      6/227 (2.64%)    
Cardiac disorders     
Acute myocardial infarction   0/223 (0.00%)  0 1/227 (0.44%)  1
Gastrointestinal disorders     
Gastric Ulcer   0/223 (0.00%)  0 1/227 (0.44%)  1
Musculoskeletal and connective tissue disorders     
Osteoarthritis   0/223 (0.00%)  0 2/227 (0.88%)  2
Intervertebral disc disorder   1/223 (0.45%)  1 0/227 (0.00%)  0
Rotator cuff syndrome   1/223 (0.45%)  1 0/227 (0.00%)  0
Nervous system disorders     
Central nervous system lesion   1/223 (0.45%)  1 0/227 (0.00%)  0
Ischaemic stroke   0/223 (0.00%)  0 1/227 (0.44%)  1
Psychiatric disorders     
Mental Status Changes   0/223 (0.00%)  0 1/227 (0.44%)  1
Respiratory, thoracic and mediastinal disorders     
Pulmonary Embolism   1/223 (0.45%)  1 0/227 (0.00%)  0
Vascular disorders     
Hypertension   0/223 (0.00%)  0 1/227 (0.44%)  1
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
A-101 Solution Vehicle Solution
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   10/223 (4.48%)      14/227 (6.17%)    
Immune system disorders     
Seasonal Allergy   0/223 (0.00%)  0 4/227 (1.76%)  4
Infections and infestations     
Nasopharyngitis   3/223 (1.35%)  3 7/227 (3.08%)  7
Bronchitis   3/223 (1.35%)  3 1/227 (0.44%)  1
Upper Respiratory Infection   1/223 (0.45%)  1 3/227 (1.32%)  3
Skin and subcutaneous tissue disorders     
Actinic Keratosis   3/223 (1.35%)  3 0/227 (0.00%)  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.
The Institution and Investigator agree not to publish the results of this study without the prior written consent of Sponsor.
Results Point of Contact
Name/Title: Judy Schnyder, Sr. Director Clinical Operations
Organization: Aclaris Therapeutics
Phone: 484-329-2144
Responsible Party: Aclaris Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT02667236     History of Changes
Other Study ID Numbers: A-101-SEBK-301
First Submitted: January 26, 2016
First Posted: January 28, 2016
Results First Submitted: October 13, 2017
Results First Posted: November 13, 2017
Last Update Posted: February 6, 2018