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Trial record 11 of 14 for:    "Keratosis seborrheic"

An Open-Label Safety Study of A-101 Solution

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: NCT02667288
Recruitment Status : Completed
First Posted : January 28, 2016
Results First Posted : November 17, 2017
Last Update Posted : February 7, 2018
Sponsor:
Information provided by (Responsible Party):
Aclaris Therapeutics, Inc.

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Seborrheic Keratosis
Intervention Drug: A-101 Solution
Enrollment 147
Recruitment Details  
Pre-assignment Details  
Arm/Group Title A-101 Solution
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A-101 Solution 40% administered topically for a maximum of 4 treatment visits

A-101 Solution

Period Title: Overall Study
Started 147
Completed 134
Not Completed 13
Reason Not Completed
Protocol Violation             5
Lost to Follow-up             3
Withdrawal by Subject             5
Arm/Group Title A-101 Solution
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A-101 Solution 40% administered topically for a maximum of 4 treatment visits

A-101 Solution

Overall Number of Baseline Participants 147
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ITT Population
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 147 participants
<=18 years
0
   0.0%
Between 18 and 65 years
46
  31.3%
>=65 years
101
  68.7%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 147 participants
68.4  (9.67)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 147 participants
Female
100
  68.0%
Male
47
  32.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 147 participants
Hispanic or Latino
5
   3.4%
Not Hispanic or Latino
133
  90.5%
Unknown or Not Reported
9
   6.1%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 147 participants
American Indian or Alaska Native
2
   1.4%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
6
   4.1%
White
138
  93.9%
More than one race
0
   0.0%
Unknown or Not Reported
1
   0.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 147 participants
147
1.Primary Outcome
Title Proportion of Subjects With Lesion Clearance
Hide Description Proportion of subjects for whom all target lesions were judged to be clear on the Physician Lesion Assessment (PWA) Scale. The PWA scale is a 4 point scale used by the investigator to assess each subject target SK Lesion.
Time Frame Study day 148
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ITT Population
Arm/Group Title A-101 Solution
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A-101 Solution 40% administered topically for a maximum of 4 treatment visits

A-101 Solution

Overall Number of Participants Analyzed 147
Measure Type: Count of Participants
Unit of Measure: Participants
16
  10.9%
2.Secondary Outcome
Title Per Subject Percent of Lesion Clearance
Hide Description Physician Lesion Assessment (PWA) average Per-Subject Percent of target lesions judged to be clear at Visit 12 in the per protocol population. The PWA scale is a 4 point scale used by the investigator to assess the subject's Target SK lesions.
Time Frame Day 148
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Per Protocol Population
Arm/Group Title A-101 Solution
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A-101 Solution 40% administered topically for a maximum of 4 treatment visits

A-101 Solution

Overall Number of Participants Analyzed 142
Mean (Standard Deviation)
Unit of Measure: percentage of lesions cleared
28.17  (35.34)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title A-101 Solution
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A-101 Solution 40% administered topically for a maximum of 4 treatment visits

A-101 Solution

All-Cause Mortality
A-101 Solution
Affected / at Risk (%)
Total   0/147 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
A-101 Solution
Affected / at Risk (%) # Events
Total   0/147 (0.00%)    
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
Affected / at Risk (%) # Events
Total   14/147 (9.52%)    
Blood and lymphatic system disorders   
Anemia  2  2/147 (1.36%)  2
Immune system disorders   
Seasonal Allergy  2  3/147 (2.04%)  3
Infections and infestations   
Sinusitis  2  3/147 (2.04%)  3
Nasopharyngitis  2  2/147 (1.36%)  2
Respiratory, thoracic and mediastinal disorders   
Cough  1  3/147 (2.04%)  3
Skin and subcutaneous tissue disorders   
Actinic Keratosis  2  2/147 (1.36%)  2
Dermatitis Contact  2  2/147 (1.36%)  2
1
Term from vocabulary, MedDRA 19.0
2
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: NCT02667288     History of Changes
Other Study ID Numbers: A-101-SEBK-303
First Submitted: January 26, 2016
First Posted: January 28, 2016
Results First Submitted: October 18, 2017
Results First Posted: November 17, 2017
Last Update Posted: February 7, 2018