Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 5 of 14 for:    "Keratosis seborrheic"

Study of Safety, Tolerability and Effectiveness of A-101 in Subjects With 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: NCT01986920
Recruitment Status : Completed
First Posted : November 19, 2013
Results First Posted : December 11, 2018
Last Update Posted : December 11, 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 (SK)
Interventions Drug: A-101 25%
Drug: A-101 32.5%
Drug: A-101 40%
Drug: A-101 Vehicle
Enrollment 35
Recruitment Details  
Pre-assignment Details In this study each patient is treated with all 4 treatments on 4 different lesions on their back. Therefore, each patient participates in each group so the total enrollment matches the number of lesions treated but not the total participants.
Arm/Group Title A-101 25% A-101 32.5% A-101 40% A-101 Vehicle
Hide Arm/Group Description

Low dose group

A-101 25%: Low Dose Concentration of A-101 applied to one of 4 Target Lesions

Mid Dose Group

A-101 32.5%: Mid Dose Concentration of A-101 applied to one of 4 Target Lesions

High Dose Group

A-101 40%: High Dose Concentration A-101 applied to one of 4 Target Lesions

Placebo group

A-101 Vehicle: Placebo applied to one of 4 Target Lesions

Period Title: A- 101 25%
Number of participants Number of units (lesions) Number of participants Number of units (lesions) Number of participants Number of units (lesions) Number of participants Number of units (lesions)
Started [1] 35 35 0 0 0 0 0 0
Completed [2] 34 34 0 0 0 0 0 0
Not Completed 1 1 0 0 0 0 0 0
Reason Not Completed
Withdrawal by Subject             1                         0                         0                         0            
[1]
It is the same 35 participants in each treatment so total participants is 35.
[2]
Participants receives all treatments, one treatment/lesion simultaneously. 1 Participant=4 lesion
Period Title: A-101 32.5%
Number of participants Number of units (lesions) Number of participants Number of units (lesions) Number of participants Number of units (lesions) Number of participants Number of units (lesions)
Started 0 0 35 35 0 0 0 0
Completed 0 0 34 34 0 0 0 0
Not Completed 0 0 1 1 0 0 0 0
Reason Not Completed
Withdrawal by Subject             0                         1                         0                         0            
Period Title: A-101 40%
Number of participants Number of units (lesions) Number of participants Number of units (lesions) Number of participants Number of units (lesions) Number of participants Number of units (lesions)
Started 0 0 0 0 35 35 0 0
Completed 0 0 0 0 34 34 0 0
Not Completed 0 0 0 0 1 1 0 0
Reason Not Completed
Withdrawal by Subject             0                         0                         1                         0            
Period Title: Placebo
Number of participants Number of units (lesions) Number of participants Number of units (lesions) Number of participants Number of units (lesions) Number of participants Number of units (lesions)
Started 0 0 0 0 0 0 35 35
Completed 0 0 0 0 0 0 34 34
Not Completed 0 0 0 0 0 0 1 1
Reason Not Completed
Withdrawal by Subject             0                         0                         0                         1            
Arm/Group Title Entire Study Population
Hide Arm/Group Description Subjects were required to have 4 Target Seborrheic Keratosis Lesions their back. Each lesion was treated with one of the four treatment interventions (A-101 Solution 25%, A-101, Solution 32.5%, A-101 Solution 40% and the A-101 Solution Vehicle) in a randomized fashion.
Overall Number of Baseline Participants 35
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 35 participants
<=18 years
0
   0.0%
Between 18 and 65 years
6
  17.1%
>=65 years
29
  82.9%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 35 participants
69.43  (6.52)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 35 participants
Female
20
  57.1%
Male
15
  42.9%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 35 participants
Hispanic or Latino
1
   2.9%
Not Hispanic or Latino
34
  97.1%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 35 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
35
 100.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 35 participants
35
 100.0%
1.Primary Outcome
Title Mean Change in Physician Lesion Assessment Scale
Hide Description

Mean Change in Score on the Physician Lesion Assessment Scale (PLA) of each Target Lesion. The PLAS is a four point scale from 0-3 with 0 being clear and 3 being the worst lesion.

The primary effectiveness will consist of the mean change from Visit 2 to Visit 9 in PLA performed using Analysis of Covariance (ANCOVA) with Visit 2 PLAS as the covariate. Comparisons between vehicle and each active treatment group will be performed within the model using least-squares means and the common error term.

Time Frame Visit 2 to visit 9 (78 days)
Hide Outcome Measure Data
Hide Analysis Population Description
A total of 35 subjects were enrolled with 34 subjects in the analysis population. Each target lesion on a subject was treated with one of the 4 study medications in a random fashion.
Arm/Group Title A-101 25% A-101 32.5% A-101 40% A-101 Vehicle
Hide Arm/Group Description:

Low dose group

A-101 25%: Low Dose Concentration of A-101 applied to one of 4 Target Lesions

Mid Dose Group

A-101 32.5%: Mid Dose Concentration of A-101 applied to one of 4 Target Lesions

High Dose Group

A-101 40%: High Dose Concentration A-101 applied to one of 4 Target Lesions

Placebo group

A-101 Vehicle: Placebo applied to one of 4 Target Lesions

Overall Number of Participants Analyzed 34 34 34 34
Mean (Standard Deviation)
Unit of Measure: Change in Score on a scale
-0.47  (0.66) -0.88  (0.73) -1.12  (0.81) -0.15  (0.36)
2.Secondary Outcome
Title Subject's Self Assessment Scale
Hide Description Subjects self assessment of the condition of their lesions based on a scale of Clear (Grade 0), Mild (Grade 1), Moderate (Grade 2), Severe (Grade 3).
Time Frame Visit 9 (Day 78)
Hide Outcome Measure Data
Hide Analysis Population Description
A total of 35 subjects were enrolled with 34 subjects in the analysis population. Each target lesion on a subject was treated with one of the 4 study medications in a random fashion.
Arm/Group Title A-101 25% A-101 32.5% A-101 40% A-101 Vehicle
Hide Arm/Group Description:

Low dose group

A-101 25%: Low Dose Concentration of A-101 applied to one of 4 Target Lesions

Mid Dose Group

A-101 32.5%: Mid Dose Concentration of A-101 applied to one of 4 Target Lesions

High Dose Group

A-101 40%: High Dose Concentration A-101 applied to one of 4 Target Lesions

Placebo group

A-101 Vehicle: Placebo applied to one of 4 Target Lesions

Overall Number of Participants Analyzed 34 34 34 34
Measure Type: Count of Participants
Unit of Measure: Participants
Clear
7
  20.6%
09
  26.5%
08
  23.5%
01
   2.9%
Mild
12
  35.3%
09
  26.5%
13
  38.2%
13
  38.2%
Moderate
13
  38.2%
12
  35.3%
11
  32.4%
18
  52.9%
Severe
02
   5.9%
04
  11.8%
02
   5.9%
02
   5.9%
Time Frame Serious adverse events were collected from the time the subject signed the informed consent until the subject's last visit. Adverse events were collected from the time immediately after the first application of the study medication until the subject's last visit.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title A-101 25% A-101 32.5% A-101 40% A-101 Vehicle
Hide Arm/Group Description

Low dose group

A-101 25%: Low Dose Concentration of A-101 applied to one of 4 Target Lesions

Mid Dose Group

A-101 32.5%: Mid Dose Concentration of A-101 applied to one of 4 Target Lesions

High Dose Group

A-101 40%: High Dose Concentration A-101 applied to one of 4 Target Lesions

Placebo group

A-101 Vehicle: Placebo applied to one of 4 Target Lesions

All-Cause Mortality
A-101 25% A-101 32.5% A-101 40% A-101 Vehicle
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/35 (0.00%)      0/35 (0.00%)      0/35 (0.00%)      0/35 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
A-101 25% A-101 32.5% A-101 40% A-101 Vehicle
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/35 (2.86%)      1/35 (2.86%)      1/35 (2.86%)      1/35 (2.86%)    
Renal and urinary disorders         
Acute Pyelonephritis  1  1/35 (2.86%)  1 1/35 (2.86%)  1 1/35 (2.86%)  1 1/35 (2.86%)  1
1
Term from vocabulary, MedDRA (14.1)
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 25% A-101 32.5% A-101 40% A-101 Vehicle
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   21/35 (60.00%)      21/35 (60.00%)      25/35 (71.43%)      25/35 (71.43%)    
Gastrointestinal disorders         
Abdominal Pain Upper  1  1/35 (2.86%)  1/35 (2.86%)  1/35 (2.86%)  1/35 (2.86%) 
Diarrhoea * 1  1/35 (2.86%)  1/35 (2.86%)  1/35 (2.86%)  1/35 (2.86%) 
Toothache * 1  1/35 (2.86%)  1/35 (2.86%)  1/35 (2.86%)  1/35 (2.86%) 
Immune system disorders         
Seasonal allergy * 1  10/35 (28.57%)  10/35 (28.57%)  10/35 (28.57%)  10/35 (28.57%) 
Injury, poisoning and procedural complications         
Wound * 1  1/35 (2.86%)  1/35 (2.86%)  1/35 (2.86%)  1/35 (2.86%) 
Musculoskeletal and connective tissue disorders         
Arthritis * 1  4/35 (11.43%)  4/35 (11.43%)  4/35 (11.43%)  4/35 (11.43%) 
Spinal column stenosis * 1  1/35 (2.86%)  1/35 (2.86%)  1/35 (2.86%)  1/35 (2.86%) 
Nervous system disorders         
Dementia Alzheimer's type * 1  1/35 (2.86%)  1/35 (2.86%)  1/35 (2.86%)  1/35 (2.86%) 
Insomnia * 1  1/35 (2.86%)  1/35 (2.86%)  1/35 (2.86%)  1/35 (2.86%) 
Psychiatric disorders         
Depression * 1  1/35 (2.86%)  1/35 (2.86%)  1/35 (2.86%)  1/35 (2.86%) 
Renal and urinary disorders         
Cystitis * 1  1/35 (2.86%)  1/35 (2.86%)  1/35 (2.86%)  1/35 (2.86%) 
Respiratory, thoracic and mediastinal disorders         
Upper respiratory tract infection * 1  1/35 (2.86%)  1/35 (2.86%)  1/35 (2.86%)  1/35 (2.86%) 
Skin and subcutaneous tissue disorders         
Crusting * 1  6/35 (17.14%)  12/35 (34.29%)  15/35 (42.86%)  0/35 (0.00%) 
Erythema * 1  8/35 (22.86%)  17/35 (48.57%)  19/35 (54.29%)  1/35 (2.86%) 
Hyperpigmentation * 1  1/35 (2.86%)  1/35 (2.86%)  1/35 (2.86%)  0/35 (0.00%) 
Hypopigmentation * 1  2/35 (5.71%)  0/35 (0.00%)  0/35 (0.00%)  0/35 (0.00%) 
Induration * 1  3/35 (8.57%)  4/35 (11.43%)  1/35 (2.86%)  0/35 (0.00%) 
Pruritus * 1  0/35 (0.00%)  0/35 (0.00%)  1/35 (2.86%)  0/35 (0.00%) 
Scaling * 1  0/35 (0.00%)  0/35 (0.00%)  5/35 (14.29%)  0/35 (0.00%) 
Stinging * 1  0/35 (0.00%)  0/35 (0.00%)  1/35 (2.86%)  0/35 (0.00%) 
1
Term from vocabulary, MedDRA (14.1)
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
Since each patient simultaneously participates in all four treatment groups only skin site related adverse events are reported by treatment group. Systemic adverse events are reported in all treatment groups the same.
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 the investigator agree not to publish the results of this study without the written approval of the Sponsor.
Results Point of Contact
Name/Title: Christopher Powala, Chief Operating Officer
Organization: Aclaris Therapeutics
Phone: 484-324-7933
Responsible Party: Aclaris Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT01986920     History of Changes
Other Study ID Numbers: A-101-SEBK-201
First Submitted: November 6, 2013
First Posted: November 19, 2013
Results First Submitted: January 9, 2017
Results First Posted: December 11, 2018
Last Update Posted: December 11, 2018