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Trial record 9 of 14 for:    "Keratosis seborrheic"

Study 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: NCT02260180
Recruitment Status : Completed
First Posted : October 9, 2014
Results First Posted : December 6, 2018
Last Update Posted : December 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
Intervention Drug: A-101
Enrollment 119
Recruitment Details  
Pre-assignment Details  
Arm/Group Title A-101 40% Topical Solution A-101 32.5% Topical Solution A-101 Vehicle Topical Solution
Hide Arm/Group Description

A-101 40% Topical Solution

A-101: Topical Solution

A-101 32.5% Topical Solution

A-101: Topical Solution

A-101 0% Topical Solution (vehicle)

A-101: Topical Solution

Period Title: Overall Study
Started 39 39 41
Completed 37 39 40
Not Completed 2 0 1
Reason Not Completed
Adverse Event             2             0             1
Arm/Group Title A-101 40% A-101 32.5% A-101 Vehicle Topical Solution Total
Hide Arm/Group Description A-101 40% Topical Solution A-101 32.5% Topical Solution A-101 0% Topical Solution (vehicle) Total of all reporting groups
Overall Number of Baseline Participants 39 39 41 119
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Mean (Full Range)
Unit of measure:  Years
Age Number Analyzed 39 participants 39 participants 41 participants 119 participants
71
(53 to 93)
71
(33 to 88)
67
(47 to 87)
70
(33 to 93)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 39 participants 39 participants 41 participants 119 participants
Female
21
  53.8%
24
  61.5%
20
  48.8%
65
  54.6%
Male
18
  46.2%
15
  38.5%
21
  51.2%
54
  45.4%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 39 participants 39 participants 41 participants 119 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
1
   2.6%
0
   0.0%
0
   0.0%
1
   0.8%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
White
38
  97.4%
39
 100.0%
41
 100.0%
118
  99.2%
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%
1.Primary Outcome
Title Mean of Per-subject Percentages of Target Lesions Judged to be Clear on the Physician's Lesion Assessment (PLA) Score (PLA = 0) at Visit 8.
Hide Description The primary efficacy analysis was the mean of per-subject percentages of target lesions judged to be clear on the PLA (PLA = 0) at Visit 8. The PLA is a four point scale from 0 to 3 with 0 being a clear lesion and 3 being the worst lesion. A comparison between each active treatment group and the vehicle treatment group based on the proportion of subjects whose target lesion is judged to be clear on the PLA (PLA = 0) at Visit 8. A higher percentage is a better outcome.
Time Frame Day 106
Hide Outcome Measure Data
Hide Analysis Population Description
Participants completing the study.
Arm/Group Title A-101 40% A-101 32.5% A-101 Vehicle Topical Solution
Hide Arm/Group Description:
A-101 40% Topical Solution
A-101 32.5% Topical Solution
A-101 0% Topical Solution (vehicle)
Overall Number of Participants Analyzed 37 39 40
Measure Type: Count of Participants
Unit of Measure: Participants
22
  59.5%
18
  46.2%
1
   2.5%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection A-101 40%, A-101 Vehicle Topical Solution
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .001
Comments not adjusted for multiple comparisons
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection A-101 32.5%, A-101 Vehicle Topical Solution
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.001
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
2.Secondary Outcome
Title Mean Change of PLA From Baseline to Visit 8
Hide Description Change from baseline PLA was calculated for each lesion first, then per-subject mean changes from baseline were calculated and served as the basis for the ANCOVA. The physician's Lesion Analysis is a 4 point scale from0 to 3, with 0 being lesion clear and 3 being the most severe lesion. For change from baseline a higher negative score is a better outcome.
Time Frame Baseline to Visit 8
Hide Outcome Measure Data
Hide Analysis Population Description
Study day01 / visit 2 has been considered as Baseline visit for calculating mean and mean change
Arm/Group Title A-101 40% A-101 32.5% A-101 Vehicle Topical Solution
Hide Arm/Group Description:
A-101 40% Topical Solution
A-101 32.5% Topical Solution
A-101 0% Topical Solution (vehicle)
Overall Number of Participants Analyzed 37 39 40
Mean (Standard Deviation)
Unit of Measure: units on a scale
-1.68  (1.11) -1.41  (1.14) -0.13  (0.56)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection A-101 40%, A-101 Vehicle Topical Solution
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0001
Comments not adjusted for multiple observations
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection A-101 32.5%, A-101 Vehicle Topical Solution
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0001
Comments not adjusted for multiple observations
Method ANCOVA
Comments [Not Specified]
Time Frame 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 (TESAEs) had a start date on or after the date of Visit 1 (Screening). Collection continued through the patients 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 A-101 40% A-101 32.5% A-101 Vehicle Topical Solution
Hide Arm/Group Description

A-101 40% Topical Solution

A-101: Topical Solution

A-101 32.5% Topical Solution

A-101: Topical Solution

A-101 0% Topical Solution (vehicle)

A-101: Topical Solution

All-Cause Mortality
A-101 40% A-101 32.5% A-101 Vehicle Topical Solution
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/39 (2.56%)      0/39 (0.00%)      0/41 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
A-101 40% A-101 32.5% A-101 Vehicle Topical Solution
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/39 (7.69%)      0/39 (0.00%)      1/41 (2.44%)    
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Malignant melanoma  1  0/39 (0.00%)  0 0/39 (0.00%)  0 1/41 (2.44%)  1
metastatic neoplasm  1  1/39 (2.56%)  1 0/39 (0.00%)  0 0/41 (0.00%)  0
Squamous cell carcinoma of skin  1  1/39 (2.56%)  1 0/39 (0.00%)  0 0/41 (0.00%)  0
Nervous system disorders       
Dizziness  1  1/39 (2.56%)  1 0/39 (0.00%)  0 0/41 (0.00%)  0
Renal and urinary disorders       
Renal failure  1  1/39 (2.56%)  1 0/39 (0.00%)  0 0/41 (0.00%)  0
1
Term from vocabulary, MedDRA (14.2)
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%
A-101 40% A-101 32.5% A-101 Vehicle Topical Solution
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   13/39 (33.33%)      7/39 (17.95%)      12/41 (29.27%)    
Ear and labyrinth disorders       
Eustacian Tube Obstruction  1  0/39 (0.00%)  0 0/39 (0.00%)  0 1/41 (2.44%)  1
Eye disorders       
Cataract  1  1/39 (2.56%)  1 0/39 (0.00%)  0 0/41 (0.00%)  0
Gastrointestinal disorders       
Gastroenteritis  1  1/39 (2.56%)  1 0/39 (0.00%)  0 0/41 (0.00%)  0
Immune system disorders       
Seasonal Allergy  1  3/39 (7.69%)  3 2/39 (5.13%)  2 3/41 (7.32%)  3
Infections and infestations       
Cystitis  1  0/39 (0.00%)  0 1/39 (2.56%)  1 0/41 (0.00%)  0
Eye infection  1  0/39 (0.00%)  0 0/39 (0.00%)  0 1/41 (2.44%)  1
Influenza  1  2/39 (5.13%)  2 0/39 (0.00%)  0 0/41 (0.00%)  0
Onychomycosis  1  0/39 (0.00%)  0 0/39 (0.00%)  0 1/41 (2.44%)  1
Oral Herpes  1  1/39 (2.56%)  1 0/39 (0.00%)  0 0/41 (0.00%)  0
Tooth abcess  1  0/39 (0.00%)  0 1/39 (2.56%)  1 0/41 (0.00%)  0
Upper respiratory tract infection  1  1/39 (2.56%)  1 1/39 (2.56%)  1 3/41 (7.32%)  3
Urinary tract infection  1  1/39 (2.56%)  1 0/39 (0.00%)  0 0/41 (0.00%)  0
Injury, poisoning and procedural complications       
Face injury  1  1/39 (2.56%)  1 0/39 (0.00%)  0 0/41 (0.00%)  0
Thermal burn  1  0/39 (0.00%)  0 1/39 (2.56%)  1 0/41 (0.00%)  0
Metabolism and nutrition disorders       
Hypocholestersterolaemia  1  0/39 (0.00%)  0 0/39 (0.00%)  0 1/41 (2.44%)  1
Musculoskeletal and connective tissue disorders       
Ligament sprain  1  0/39 (0.00%)  0 1/39 (2.56%)  1 0/41 (0.00%)  0
Neck pain  1  1/39 (2.56%)  1 0/39 (0.00%)  0 0/41 (0.00%)  0
Tendonitis  1  1/39 (2.56%)  1 0/39 (0.00%)  0 0/41 (0.00%)  0
Nervous system disorders       
Carpal tunnel syndrome  1  0/39 (0.00%)  0 0/39 (0.00%)  0 1/41 (2.44%)  1
Sinus Headache  1  0/39 (0.00%)  0 1/39 (2.56%)  1 0/41 (0.00%)  0
Respiratory, thoracic and mediastinal disorders       
Bronchitis  1  0/39 (0.00%)  0 0/39 (0.00%)  0 2/41 (4.88%)  2
Sinusitis  1  1/39 (2.56%)  1 1/39 (2.56%)  1 0/41 (0.00%)  0
Skin and subcutaneous tissue disorders       
Actinic Keratosis  1  0/39 (0.00%)  0 0/39 (0.00%)  0 1/41 (2.44%)  1
Ecchymosis  1  1/39 (2.56%)  1 0/39 (0.00%)  0 0/41 (0.00%)  0
Vascular disorders       
Skin Haemorrhage  1  0/39 (0.00%)  0 1/39 (2.56%)  1 0/41 (0.00%)  0
1
Term from vocabulary, MedDRA (14.2)
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: Judith Schnyder, Senior Director of Clinical Operations
Organization: Aclaris Therapeutics, Inc.
Phone: 1-484-329-2144
Responsible Party: Aclaris Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT02260180     History of Changes
Other Study ID Numbers: A-101-SEBK-203
First Submitted: October 3, 2014
First Posted: October 9, 2014
Results First Submitted: September 30, 2018
Results First Posted: December 6, 2018
Last Update Posted: December 6, 2018