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Trial record 8 of 14 for:    "Keratosis seborrheic"

A Randomized, Vehicle-Controlled Study of 2 Concentrations of A-101 for the Treatment of Seborrheic Keratosis

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: NCT03148691
Recruitment Status : Completed
First Posted : May 11, 2017
Results First Posted : May 6, 2019
Last Update Posted : May 6, 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 Seborrheic Keratosis
Intervention Drug: A-101
Enrollment 253
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Vehicle A-101 Low Dose A-101 High Dose
Hide Arm/Group Description

Vehicle Topical Solution

A-101: Topical Solution

A-101 Low Dose Topical Solution

A-101: Topical Solution

A-101 High DoseTopical Solution

A-101: Topical Solution

Period Title: Overall Study
Started 50 103 100
Completed 47 101 92
Not Completed 3 2 8
Reason Not Completed
Protocol Violation             1             2             7
Lost to Follow-up             0             0             1
Other             1             0             0
Withdrawal by Subject             1             0             0
Arm/Group Title Vehicle A-101 Low Dose A-101 High Dose Total
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Vehicle Topical Solution

A-101: Topical Solution

A-101 Low Dose Topical Solution

A-101: Topical Solution

A-101 High DoseTopical Solution

A-101: Topical Solution

Total of all reporting groups
Overall Number of Baseline Participants 50 103 100 253
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants 103 participants 100 participants 253 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
14
  28.0%
30
  29.1%
21
  21.0%
65
  25.7%
>=65 years
36
  72.0%
73
  70.9%
79
  79.0%
188
  74.3%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 50 participants 103 participants 100 participants 253 participants
69.0  (8.27) 69.1  (8.75) 70.0  (8.12) 69.5  (8.39)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants 103 participants 100 participants 253 participants
Female
31
  62.0%
59
  57.3%
67
  67.0%
157
  62.1%
Male
19
  38.0%
44
  42.7%
33
  33.0%
96
  37.9%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants 103 participants 100 participants 253 participants
Hispanic or Latino
3
   6.0%
9
   8.7%
4
   4.0%
16
   6.3%
Not Hispanic or Latino
43
  86.0%
89
  86.4%
88
  88.0%
220
  87.0%
Unknown or Not Reported
4
   8.0%
5
   4.9%
8
   8.0%
17
   6.7%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants 103 participants 100 participants 253 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
1
   1.0%
0
   0.0%
1
   0.4%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
4
   8.0%
4
   3.9%
8
   8.0%
16
   6.3%
White
46
  92.0%
98
  95.1%
92
  92.0%
236
  93.3%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 50 participants 103 participants 100 participants 253 participants
50 103 100 253
1.Primary Outcome
Title Mean of Per Subject Percentages of Target Lesions Judged to be Clear (PWA=0) at Visit 8
Hide Description

Mean of per subject percentages of target lesions judged to be clear (PWA=0) at Visit 8

Grade Descriptor

0 Clear: no visible seborrheic keratosis lesion

  1. Near Clear: a visible seborrheic keratosis lesion with a surface appearance different from the surrounding skin (not elevated)
  2. Thin: a visible seborrheic keratosis lesion (thickness ≤ 1 mm)
  3. Thick: a visible seborrheic keratosis lesion (thickness > 1 mm)
Time Frame Day 106
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Hide Analysis Population Description
[Not Specified]
Arm/Group Title Vehicle A-101 Low Dose A-101 High Dose
Hide Arm/Group Description:

Vehicle Topical Solution

A-101: Topical Solution

A-101 Low Dose Topical Solution

A-101: Topical Solution

A-101 High DoseTopical Solution

A-101: Topical Solution

Overall Number of Participants Analyzed 47 101 92
Overall Number of Units Analyzed
Type of Units Analyzed: Lesions
188 404 368
Mean (Standard Deviation)
Unit of Measure: Per-Subject Percent of Lesions Clear
3.72  (10.4) 49.5  (36.74) 57.88  (35.92)
Time Frame 11.5 months; 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 the subject's last visit or the end of the study, visit 8 (Day 106.)
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 Vehicle A-101 Low Dose A-101 High Dose
Hide Arm/Group Description

Vehicle Topical Solution

A-101: Topical Solution

A-101 Low Dose Topical Solution

A-101: Topical Solution

A-101 High DoseTopical Solution

A-101: Topical Solution

All-Cause Mortality
Vehicle A-101 Low Dose A-101 High Dose
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/50 (0.00%)      0/103 (0.00%)      0/100 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Vehicle A-101 Low Dose A-101 High Dose
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/50 (2.00%)      2/103 (1.94%)      1/100 (1.00%)    
Cardiac disorders       
Atrial Fibrillation  1  1/50 (2.00%)  1 0/103 (0.00%)  0 0/100 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Pancreatic Cancer  1  0/50 (0.00%)  0 0/103 (0.00%)  0 1/100 (1.00%)  1
Nervous system disorders       
Syncope and Collapse  1  0/50 (0.00%)  0 1/103 (0.97%)  1 0/100 (0.00%)  0
Vascular disorders       
Deep Vein Thrombosis  1  0/50 (0.00%)  0 1/103 (0.97%)  1 0/100 (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 0%
Vehicle A-101 Low Dose A-101 High Dose
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   11/50 (22.00%)      18/103 (17.48%)      26/100 (26.00%)    
Cardiac disorders       
Atrial Fibrillation  1  1/50 (2.00%)  1 0/103 (0.00%)  0 0/100 (0.00%)  0
Bundle Branch Block Left  1  0/50 (0.00%)  0 1/103 (0.97%)  1 0/100 (0.00%)  0
Tachycardia  1  1/50 (2.00%)  1 0/103 (0.00%)  0 0/100 (0.00%)  0
Eye disorders       
Eyelid Oedema  1  0/50 (0.00%)  0 1/103 (0.97%)  1 1/100 (1.00%)  1
Ocular Hypertension  1  0/50 (0.00%)  0 1/103 (0.97%)  1 0/100 (0.00%)  0
Gastrointestinal disorders       
Abdominal Discomfort  1  1/50 (2.00%)  1 0/103 (0.00%)  0 0/100 (0.00%)  0
General disorders       
Malaise  1  0/50 (0.00%)  0 1/103 (0.97%)  1 0/100 (0.00%)  0
Hepatobiliary disorders       
Bile Duct Obstruction  1  0/50 (0.00%)  0 0/103 (0.00%)  0 1/100 (1.00%)  1
Immune system disorders       
Seasonal allergy  1  0/50 (0.00%)  0 1/103 (0.97%)  1 0/100 (0.00%)  0
Infections and infestations       
Bronchitis  1  1/50 (2.00%)  1 0/103 (0.00%)  0 3/100 (3.00%)  3
Nasopharyngitis  1  1/50 (2.00%)  1 2/103 (1.94%)  2 2/100 (2.00%)  2
Gastroenteritis viral  1  0/50 (0.00%)  0 1/103 (0.97%)  1 1/100 (1.00%)  1
Cellulitis  1  0/50 (0.00%)  0 0/103 (0.00%)  0 1/100 (1.00%)  1
Cystitis  1  0/50 (0.00%)  0 0/103 (0.00%)  0 1/100 (1.00%)  1
Gastroenteritis  1  0/50 (0.00%)  0 0/103 (0.00%)  0 1/100 (1.00%)  1
Hordeolum  1  0/50 (0.00%)  0 0/103 (0.00%)  0 1/100 (1.00%)  1
Influenza  1  0/50 (0.00%)  0 0/103 (0.00%)  0 1/100 (1.00%)  1
Viral upper respiratory tract infection  1  0/50 (0.00%)  0 0/103 (0.00%)  0 1/100 (1.00%)  1
Upper respiratory tract infection  1  1/50 (2.00%)  1 1/103 (0.97%)  1 0/100 (0.00%)  0
Body Tinea  1  0/50 (0.00%)  0 1/103 (0.97%)  1 0/100 (0.00%)  0
Folliculitis  1  0/50 (0.00%)  0 1/103 (0.97%)  1 0/100 (0.00%)  0
Oral herpes  1  0/50 (0.00%)  0 1/103 (0.97%)  1 0/100 (0.00%)  0
Post operative wound infection  1  0/50 (0.00%)  0 1/103 (0.97%)  1 0/100 (0.00%)  0
Sinusitis  1  0/50 (0.00%)  0 1/103 (0.97%)  1 0/100 (0.00%)  0
Staphylococcal skin infection  1  0/50 (0.00%)  0 1/103 (0.97%)  1 0/100 (0.00%)  0
Viral infection  1  0/50 (0.00%)  0 1/103 (0.97%)  1 0/100 (0.00%)  0
Injury, poisoning and procedural complications       
Fall  1  0/50 (0.00%)  0 0/103 (0.00%)  0 1/100 (1.00%)  1
Laceration  1  0/50 (0.00%)  0 0/103 (0.00%)  0 1/100 (1.00%)  1
Tooth injury  1  0/50 (0.00%)  0 0/103 (0.00%)  0 1/100 (1.00%)  1
Arthropod sting  1  0/50 (0.00%)  0 1/103 (0.97%)  1 0/100 (0.00%)  0
Muscle strain  1  0/50 (0.00%)  0 1/103 (0.97%)  1 0/100 (0.00%)  0
Skin abrasion  1  0/50 (0.00%)  0 1/103 (0.97%)  1 0/100 (0.00%)  0
Spinal compression fracture  1  1/50 (2.00%)  1 0/103 (0.00%)  0 0/100 (0.00%)  0
Thermal burn  1  1/50 (2.00%)  1 0/103 (0.00%)  0 0/100 (0.00%)  0
Investigations       
Hepatic enzyme increased  1  0/50 (0.00%)  0 0/103 (0.00%)  0 1/100 (1.00%)  1
Blood osmolarity decreased  1  0/50 (0.00%)  0 1/103 (0.97%)  1 0/100 (0.00%)  0
Metabolism and nutrition disorders       
Hypercholesterolemia  1  0/50 (0.00%)  0 0/103 (0.00%)  0 1/100 (1.00%)  1
Hyponatremia  1  1/50 (2.00%)  1 1/103 (0.97%)  1 0/100 (0.00%)  0
Dehydration  1  0/50 (0.00%)  0 1/103 (0.97%)  1 0/100 (0.00%)  0
Musculoskeletal and connective tissue disorders       
Arthritis  1  0/50 (0.00%)  0 0/103 (0.00%)  0 1/100 (1.00%)  1
Bursitis  1  0/50 (0.00%)  0 0/103 (0.00%)  0 1/100 (1.00%)  1
Rotator cuff syndrome  1  1/50 (2.00%)  1 0/103 (0.00%)  0 0/100 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Basal cell carcinoma  1  0/50 (0.00%)  0 1/103 (0.97%)  1 1/100 (1.00%)  1
Pancreatic carcinoma  1  0/50 (0.00%)  0 0/103 (0.00%)  0 1/100 (1.00%)  1
Squamous cell carcinoma  1  0/50 (0.00%)  0 0/103 (0.00%)  0 1/100 (1.00%)  1
Benign neoplasm of skin  1  1/50 (2.00%)  1 0/103 (0.00%)  0 0/100 (0.00%)  0
Nervous system disorders       
Headache  1  0/50 (0.00%)  0 0/103 (0.00%)  0 2/100 (2.00%)  2
Parkinson's disease  1  0/50 (0.00%)  0 0/103 (0.00%)  0 1/100 (1.00%)  1
Presyncope  1  0/50 (0.00%)  0 0/103 (0.00%)  0 1/100 (1.00%)  1
Syncope  1  0/50 (0.00%)  0 1/103 (0.97%)  1 0/100 (0.00%)  0
Renal and urinary disorders       
Pollakiuria  1  0/50 (0.00%)  0 0/103 (0.00%)  0 1/100 (1.00%)  1
Polyuria  1  0/50 (0.00%)  0 0/103 (0.00%)  0 1/100 (1.00%)  1
Respiratory, thoracic and mediastinal disorders       
Asthma  1  0/50 (0.00%)  0 0/103 (0.00%)  0 1/100 (1.00%)  1
Cough  1  0/50 (0.00%)  0 1/103 (0.97%)  1 0/100 (0.00%)  0
Dyspnoea  1  1/50 (2.00%)  1 0/103 (0.00%)  0 0/100 (0.00%)  0
Skin and subcutaneous tissue disorders       
Drug eruption  1  0/50 (0.00%)  0 0/103 (0.00%)  0 2/100 (2.00%)  2
Dermatitis contact  1  1/50 (2.00%)  1 0/103 (0.00%)  0 1/100 (1.00%)  1
Actinic keratosis  1  0/50 (0.00%)  0 1/103 (0.97%)  1 0/100 (0.00%)  0
Eczema asteatotic  1  0/50 (0.00%)  0 1/103 (0.97%)  1 0/100 (0.00%)  0
Pruritis  1  0/50 (0.00%)  0 1/103 (0.97%)  1 0/100 (0.00%)  0
Seborrhoeic dermatitis  1  1/50 (2.00%)  1 0/103 (0.00%)  0 0/100 (0.00%)  0
Vascular disorders       
Hypertension  1  0/50 (0.00%)  0 2/103 (1.94%)  2 0/100 (0.00%)  0
Deep Vein Thrombosis  1  0/50 (0.00%)  0 1/103 (0.97%)  1 0/100 (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 NOT 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
Name/Title: Executive Director, Clinical Operations
Organization: Aclaris Therapeutics
Phone: 4843247933
Responsible Party: Aclaris Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT03148691     History of Changes
Other Study ID Numbers: A-101-SEBK-204
First Submitted: May 9, 2017
First Posted: May 11, 2017
Results First Submitted: February 13, 2019
Results First Posted: May 6, 2019
Last Update Posted: May 6, 2019