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A Study of A-101 Topical Solution in Subjects With Dermatosis Papulosa Nigra

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: NCT03224598
Recruitment Status : Completed
First Posted : July 21, 2017
Results First Posted : February 10, 2020
Last Update Posted : March 30, 2020
Sponsor:
Information provided by (Responsible Party):
Aclaris Therapeutics, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Dermatosis Papulosa Nigra
Intervention Drug: A-101 Topical Solution 40%
Enrollment 39
Recruitment Details  
Pre-assignment Details  
Arm/Group Title No Medical Abrading Medically Abrading Initial Cohort - no Medical Abrading
Hide Arm/Group Description

A-101 40% without medically abrading the identified DPN prior to treatment

A-101 Topical Solution 40%: A-101 Topical Solution 40%

A-101 40% with the identified DPN lesions medically abraded prior to treatment

A-101 Topical Solution 40%: A-101 Topical Solution 40%

initial cohort no medical abrading different treatment schedule
Period Title: Overall Study
Started 9 17 13
Completed 9 14 13
Not Completed 0 3 0
Reason Not Completed
Lost to Follow-up             0             2             0
Other             0             1             0
Arm/Group Title No Medical Abrading Medically Abrading Initial Cohort - no Medical Abrading Total
Hide Arm/Group Description

A-101 40% without medically abrading the identified DPN prior to treatment

A-101 Topical Solution 40%: A-101 Topical Solution 40%

A-101 40% with the identified DPN lesions medically abraded prior to treatment

A-101 Topical Solution 40%: A-101 Topical Solution 40%

A-101 40% without medically abrading the identified DPN prior to treatment

A-101 Topical Solution 40%: A-101 Topical Solution 40%

initial cohort no medical abrading different treatment schedule

Total of all reporting groups
Overall Number of Baseline Participants 9 17 13 39
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants 17 participants 13 participants 39 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
5
  55.6%
11
  64.7%
6
  46.2%
22
  56.4%
>=65 years
4
  44.4%
6
  35.3%
7
  53.8%
17
  43.6%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants 17 participants 13 participants 39 participants
Female
8
  88.9%
13
  76.5%
8
  61.5%
29
  74.4%
Male
1
  11.1%
4
  23.5%
5
  38.5%
10
  25.6%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants 17 participants 13 participants 39 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
9
 100.0%
16
  94.1%
13
 100.0%
38
  97.4%
White
0
   0.0%
1
   5.9%
0
   0.0%
1
   2.6%
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 9 participants 17 participants 13 participants 39 participants
9 17 13 39
Fitzpatrick Skin Type  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants 17 participants 13 participants 39 participants
fitzpatrick 5: Rarely burns, tans darkly easily
7
  77.8%
10
  58.8%
8
  61.5%
25
  64.1%
fitzpatrick 6: Never burns, always tans darkly
2
  22.2%
7
  41.2%
5
  38.5%
14
  35.9%
1.Primary Outcome
Title Physician's DPN Lesions Assessment
Hide Description

Efficacy endpoints will include summary statistics (frequency distributions, proportions, means, medians and standard deviations, as appropriate) by visit for the following parameters: Physician's DPN Lesion Assessment scale results per treated lesion, subject responders defined by Physician's DPN Lesion Assessment scale outcome, and changes from baseline treated lesion diameter

Physician's DPN Lesion Assessment Grade Descriptor 0 Clear: no visible DPN lesion;

  1. Near Clear: a slightly visible DPN lesion; lesion may be macular
  2. Small: a visible DPN lesion with a diameter of less than 3 mm
  3. Large : a visible DPN lesion that is elevated with a diameter of ≥3 mm
Time Frame Day 106
Hide Outcome Measure Data
Hide Analysis Population Description
per-protocol
Arm/Group Title No Medical Abrading Medically Abrading Initial Cohort - no Medical Abrading
Hide Arm/Group Description:

A-101 40% without medically abrading the identified DPN prior to treatment

A-101 Topical Solution 40%: A-101 Topical Solution 40%

A-101 40% with the identified DPN lesions medically abraded prior to treatment

A-101 Topical Solution 40%: A-101 Topical Solution 40%

initial cohort no medical abrading different treatment schedule
Overall Number of Participants Analyzed 9 14 13
Mean (Standard Deviation)
Unit of Measure: score on a scale (PLA)
-0.75  (0.52) -1.38  (0.90) -0.92  (0.95)
Time Frame 106 days
Adverse Event Reporting Description

An adverse event (AE) is any untoward medical occurrence in a patient that develops or worsens in severity during the conduct of a clinical study of a pharmaceutical product and does not necessarily have a causal relationship to the study drug.

assessed at all visits

 
Arm/Group Title No Medical Abrading Medically Abrading Initial Cohort - no Medical Abrading
Hide Arm/Group Description

A-101 40% without medically abrading the identified DPN prior to treatment

A-101 Topical Solution 40%: A-101 Topical Solution 40%

A-101 40% with the identified DPN lesions medically abraded prior to treatment

A-101 Topical Solution 40%: A-101 Topical Solution 40%

initial cohort no medical abrading different treatment schedule
All-Cause Mortality
No Medical Abrading Medically Abrading Initial Cohort - no Medical Abrading
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/9 (0.00%)      0/17 (0.00%)      0/13 (0.00%)    
Hide Serious Adverse Events
No Medical Abrading Medically Abrading Initial Cohort - no Medical Abrading
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/9 (0.00%)      0/17 (0.00%)      0/13 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
No Medical Abrading Medically Abrading Initial Cohort - no Medical Abrading
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/9 (11.11%)      2/17 (11.76%)      1/13 (7.69%)    
Eye disorders       
eye pain  1  0/9 (0.00%)  0 0/17 (0.00%)  0 1/13 (7.69%)  1
Lacrimation increased  1  0/9 (0.00%)  0 0/17 (0.00%)  0 1/13 (7.69%)  1
Infections and infestations       
Upper respiratory tract infection  1  0/9 (0.00%)  0 1/17 (5.88%)  1 0/13 (0.00%)  0
Musculoskeletal and connective tissue disorders       
Muscle strain  1  1/9 (11.11%)  1 0/17 (0.00%)  0 0/13 (0.00%)  0
Nervous system disorders       
headache  1  0/9 (0.00%)  0 0/17 (0.00%)  0 1/13 (7.69%)  1
Skin and subcutaneous tissue disorders       
Rash vesicular  1  0/9 (0.00%)  0 1/17 (5.88%)  1 0/13 (0.00%)  0
1
Term from vocabulary, MedDRA (21.1)
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
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: NCT03224598    
Other Study ID Numbers: A-101-DPN-201
First Submitted: July 5, 2017
First Posted: July 21, 2017
Results First Submitted: January 14, 2020
Results First Posted: February 10, 2020
Last Update Posted: March 30, 2020