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Trial record 2 of 14 for:    "Keratosis seborrheic"

A Randomized, Double-Blind, Vehicle-Controlled Study in Subjects With Seborrheic Keratosis (SK)

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: NCT02667275
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 487
Recruitment Details  
Pre-assignment Details  
Arm/Group Title A-101 Solution Vehicle Solution
Hide Arm/Group Description

A-101 Solution 40% administered once

A-101 Solution

Vehicle Solution administered once

Vehicle Solution: Placebo

Period Title: Overall Study
Started 244 243
Completed 233 228
Not Completed 11 15
Reason Not Completed
Protocol Violation             11             7
Lost to Follow-up             0             2
Withdrawal by Subject             0             5
Discontinued early without completing             0             1
Arm/Group Title A-101 Solution Vehicle Solution Total
Hide Arm/Group Description

A-101 Solution 40% administered once

A-101 Solution

Vehicle Solution administered once

Vehicle Solution: Placebo

Total of all reporting groups
Overall Number of Baseline Participants 244 243 487
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 244 participants 243 participants 487 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
82
  33.6%
74
  30.5%
156
  32.0%
>=65 years
162
  66.4%
169
  69.5%
331
  68.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 244 participants 243 participants 487 participants
68.4  (8.92) 69.1  (8.64) 68.7  (8.78)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 244 participants 243 participants 487 participants
Female
148
  60.7%
136
  56.0%
284
  58.3%
Male
96
  39.3%
107
  44.0%
203
  41.7%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 244 participants 243 participants 487 participants
Hispanic or Latino
12
   4.9%
14
   5.8%
26
   5.3%
Not Hispanic or Latino
229
  93.9%
222
  91.4%
451
  92.6%
Unknown or Not Reported
3
   1.2%
7
   2.9%
10
   2.1%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 244 participants 243 participants 487 participants
American Indian or Alaska Native
0
   0.0%
1
   0.4%
1
   0.2%
Asian
0
   0.0%
2
   0.8%
2
   0.4%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
3
   1.2%
3
   1.2%
6
   1.2%
White
241
  98.8%
236
  97.1%
477
  97.9%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
1
   0.4%
1
   0.2%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 244 participants 243 participants 487 participants
244 243 487
1.Primary Outcome
Title Proportion of Subjects With All Target Lesions Cleared According to Physician Lesion Assessment Scale
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 Physician Lesion Assessment Scale is a 4 point scale used by the investigator to assess the subject's target sk lesions.
Time Frame Study day 106
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title A-101 Solution Vehicle Solution
Hide Arm/Group Description:

A-101 Solution 40% administered once

A-101 Solution

Vehicle Solution administered once

Vehicle Solution: Placebo

Overall Number of Participants Analyzed 244 243
Measure Type: Count of Participants
Unit of Measure: Participants
19
   7.8%
0
   0.0%
2.Secondary Outcome
Title Percent of Lesions Cleared Scale
Hide Description Proportion of Subjects for whom at least 3 of 4 target lesions were judged to be clear on the Physician Lesion Assessment Scale (PLA=0) at Visit 8
Time Frame Study day 106
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title A-101 Solution Vehicle Solution
Hide Arm/Group Description:

A-101 Solution 40% administered once

A-101 Solution

Vehicle Solution administered once

Vehicle Solution: Placebo

Overall Number of Participants Analyzed 244 243
Measure Type: Count of Participants
Unit of Measure: Participants
56
  23.0%
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% administered once

A-101 Solution

Vehicle Solution administered once

Vehicle Solution: Placebo

All-Cause Mortality
A-101 Solution Vehicle Solution
Affected / at Risk (%) Affected / at Risk (%)
Total   0/244 (0.00%)      0/243 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
A-101 Solution Vehicle Solution
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   6/244 (2.46%)      4/243 (1.65%)    
Cardiac disorders     
Angina Pectoris  1  1/244 (0.41%)  1 0/243 (0.00%)  0
Sinus Node Dysfunction  1  1/244 (0.41%)  1 0/243 (0.00%)  0
General disorders     
Chest Pain  1  0/244 (0.00%)  0 1/243 (0.41%)  1
Infections and infestations     
Appendicitis  1  0/244 (0.00%)  0 1/243 (0.41%)  1
Injury, poisoning and procedural complications     
Pubis Fracture  1  1/244 (0.41%)  1 0/243 (0.00%)  0
Pulmonary Contusion  1  1/244 (0.41%)  1 0/243 (0.00%)  0
Rib Fracture  1  1/244 (0.41%)  1 0/243 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Intervertebral Disc Degeneration  1  0/244 (0.00%)  0 1/243 (0.41%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Breast Cancer Stage II  1  0/244 (0.00%)  0 1/243 (0.41%)  1
Nervous system disorders     
Dementia  1  1/244 (0.41%)  1 0/243 (0.00%)  0
Precerebral artery occlusion  1  1/244 (0.41%)  1 0/243 (0.00%)  0
Post traumatic Stress Disorder  1  1/244 (0.41%)  1 0/243 (0.00%)  0
Psychiatric disorders     
Anxiety  1  1/244 (0.41%)  1 0/243 (0.00%)  0
Surgical and medical procedures     
Coronary arterial stent insertion  1  1/244 (0.41%)  1 0/243 (0.00%)  0
1
Term from vocabulary, MedDRA (19.0)
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   8/244 (3.28%)      7/243 (2.88%)    
Infections and infestations     
Sinusitis  1  4/244 (1.64%)  4 4/243 (1.65%)  4
Nasopharyngitis  1  1/244 (0.41%)  1 3/243 (1.23%)  3
Herpes Zoster  1  3/244 (1.23%)  3 0/243 (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.
The Institution and Investigator agree not to publish the results of this study without the prior written consent of the 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: NCT02667275     History of Changes
Other Study ID Numbers: A-101-SEBK-302
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