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An A Study Assessing Subject Satisfaction With A-101 Topical Solution for Seborrheic Keratoses (SK-FAN)

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: NCT03487588
Recruitment Status : Completed
First Posted : April 4, 2018
Results First Posted : October 2, 2019
Last Update Posted : October 2, 2019
Sponsor:
Information provided by (Responsible Party):
Aclaris Therapeutics, Inc.

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Seborrheic Keratosis
Intervention Drug: A-101 Topical Solution
Enrollment 41
Recruitment Details  
Pre-assignment Details  
Arm/Group Title A-101 Topical Solution
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A-101 Topical Solution: A-101 Topical Solution applied Day 1, Day 15 and Day 29

Period Title: Overall Study
Started 41
Completed 41
Not Completed 0
Arm/Group Title A-101 Topical Solution
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A-101 Topical Solution: A-101 Topical Solution applied Day 1, Day 15 and Day 29

Overall Number of Baseline Participants 41
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[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 41 participants
62.4  (6.97)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 41 participants
Female
24
  58.5%
Male
17
  41.5%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 41 participants
Hispanic or Latino
0
   0.0%
Not Hispanic or Latino
41
 100.0%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 41 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
41
 100.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 41 participants
41
1.Primary Outcome
Title Subject Satisfaction
Hide Description Subject Satisfaction Questionnaire after treatment with A-101 Topical Solution
Time Frame Day 113
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[Not Specified]
Arm/Group Title A-101 Topical Solution
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A-101 Topical Solution: A-101 Topical Solution applied Day 1, Day 15 and Day 29

Overall Number of Participants Analyzed 41
Measure Type: Count of Participants
Unit of Measure: Participants
very satisfied (5)
21
  51.2%
satsified (4)
14
  34.1%
moderately satisfied (3)
4
   9.8%
slightly satisfied (2)
0
   0.0%
not satisfied at all (1)
2
   4.9%
2.Secondary Outcome
Title Effectiveness of Treatment
Hide Description Effectiveness of treatment as measured by the Physician Lesion Assessment scale. The Physician Lesion Assessment Scale (PLA) is a 4 point scale used by the investigator to assess each subjects SK lesion. PLA=0 (Clear);PLA=1 (Near Clear; not elevated); PLA=2 (Thin;thickness </= 1 mm); PLA=3 (Thick; thickness > 1 mm).
Time Frame Day 113
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[Not Specified]
Arm/Group Title A-101 Topical Solution
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A-101 Topical Solution: A-101 Topical Solution applied Day 1, Day 15 and Day 29

Overall Number of Participants Analyzed 41
Mean (Standard Deviation)
Unit of Measure: score on a scale (PLA)
-2.0  (0.62)
3.Secondary Outcome
Title Comparison of Physician Lesion Assessment Score (PLA) to Subject Satisfaction
Hide Description Effectiveness of treatment assessed by PLA (4-point scale) compared to subject reported satisfaction with treatment. The PLA scale is a 4 point scale used by the investigator to assess each subject's SK lesion.
Time Frame Day 113
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[Not Specified]
Arm/Group Title A-101 Topical Solution
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A-101 Topical Solution: A-101 Topical Solution applied Day 1, Day 15 and Day 29

Overall Number of Participants Analyzed 41
Measure Type: Number
Unit of Measure: point bi-serial correlation coefficient
.318
Time Frame 17 weeks; The reporting period for SAEs began when the subject signed the informed consent form. Non serious clinical AEs were collected following the application of the study drug at Visit 2 and continued through Visit 11. All safety reporting (AEs and SAEs) was concluded at Visit 11 (Day 113).
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 A-101 Topical Solution
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A-101 Topical Solution: A-101 Topical Solution applied Day 1, Day 15 and Day 29

All-Cause Mortality
A-101 Topical Solution
Affected / at Risk (%)
Total   0/41 (0.00%)    
Hide Serious Adverse Events
A-101 Topical Solution
Affected / at Risk (%) # Events
Total   0/41 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
A-101 Topical Solution
Affected / at Risk (%) # Events
Total   8/41 (19.51%)    
Eye disorders   
Eyelid Oedema  1  2/41 (4.88%)  2
General disorders   
Administration site discomfort  1  1/41 (2.44%)  1
Administration site irritation  1  1/41 (2.44%)  1
Injury, poisoning and procedural complications   
Arthropod sting  1  1/41 (2.44%)  1
Fall  1  1/41 (2.44%)  1
Investigations   
Blood cholesterol increased  1  1/41 (2.44%)  1
Skin and subcutaneous tissue disorders   
Dermatitis contact  1  1/41 (2.44%)  1
Surgical and medical procedures   
Tooth extraction  1  1/41 (2.44%)  1
1
Term from vocabulary, MedDRA (Unspecified)
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: 4843247933
EMail: jschnyder@aclaristx.com
Layout table for additonal information
Responsible Party: Aclaris Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT03487588    
Other Study ID Numbers: A-101-SEBK-402
First Submitted: March 2, 2018
First Posted: April 4, 2018
Results First Submitted: September 12, 2019
Results First Posted: October 2, 2019
Last Update Posted: October 2, 2019