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Trial record 3 of 14 for:    "Keratosis seborrheic"

Dose-Response Profile 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: NCT02160626
Recruitment Status : Completed
First Posted : June 11, 2014
Results First Posted : December 7, 2018
Last Update Posted : January 3, 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
Interventions Drug: A-101 Vehicle
Drug: A-101 (40) Topical Solution
Drug: A-101 (32.5) Topical Solution
Enrollment 172
Recruitment Details  
Pre-assignment Details  
Arm/Group Title A-101 Vehicle A-101 (40%) Topical Solution A-101 (32.5%) Topical Solution
Hide Arm/Group Description

A-101 Vehicle (placebo) Topical Solution

A-101 Vehicle: Placebo control

A-101 (40%) Topical Solution - high dose

A-101 (40) Topical Solution: A-101 (40) Topical Solution - high dose

A-101 (32.5%) Topical Solution - low dose

A-101 (32.5) Topical Solution: A-101 (32.5) Topical Solution - low dose

Period Title: Overall Study
Started 58 57 57
Completed 57 56 56
Not Completed 1 1 1
Reason Not Completed
Adverse Event             1             0             0
Schedule not conducive to study visits             0             0             1
Withdrawal by Subject             0             1             0
Arm/Group Title A-101 Vehicle A-101 (40%) Topical Solution A-101 (32.5%) Topical Solution Total
Hide Arm/Group Description

A-101 Vehicle (placebo) Topical Solution

A-101 Vehicle: Placebo control

A-101 (40%) Topical Solution - high dose

A-101 (40%) Topical Solution: A-101 (40%) Topical Solution - high dose

A-101 (32.5%) Topical Solution - low dose

A-101 (32.5%) Topical Solution: A-101 (32.5%) Topical Solution - low dose

Total of all reporting groups
Overall Number of Baseline Participants 58 57 57 172
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 58 participants 57 participants 57 participants 172 participants
18-55
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
56-70
2
   3.4%
1
   1.8%
0
   0.0%
3
   1.7%
71 +
56
  96.6%
56
  98.2%
57
 100.0%
169
  98.3%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 58 participants 57 participants 57 participants 172 participants
Female
30
  51.7%
33
  57.9%
28
  49.1%
91
  52.9%
Male
28
  48.3%
24
  42.1%
29
  50.9%
81
  47.1%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 58 participants 57 participants 57 participants 172 participants
Hispanic or Latino
1
   1.7%
0
   0.0%
0
   0.0%
1
   0.6%
Not Hispanic or Latino
57
  98.3%
57
 100.0%
57
 100.0%
171
  99.4%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 58 participants 57 participants 57 participants 172 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
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
White
58
 100.0%
56
  98.2%
57
 100.0%
171
  99.4%
More than one race
0
   0.0%
1
   1.8%
0
   0.0%
1
   0.6%
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 58 participants 57 participants 57 participants 172 participants
58 57 57 172
Fitzpatrick skin type   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 58 participants 57 participants 57 participants 172 participants
1
4
   6.9%
4
   7.0%
3
   5.3%
11
   6.4%
2
13
  22.4%
27
  47.4%
24
  42.1%
64
  37.2%
3
30
  51.7%
19
  33.3%
20
  35.1%
69
  40.1%
4
11
  19.0%
6
  10.5%
10
  17.5%
27
  15.7%
5
0
   0.0%
1
   1.8%
0
   0.0%
1
   0.6%
6
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
[1]
Measure Description: Fitzpatrick skin type is a six point scale that evaluates the skin coloration of the patient with one being the lightest and 6 being the darkest skin coloration.
1.Primary Outcome
Title Mean Per Subject Percentage Target Lesions Judged Clear by the Physician's Lesion Assessment (PLA)
Hide Description Mean of per-subject percentages of target lesions judged to be clear on the PLA (PLA = 0) at end of study (Visit 8). The PLA is a four point scale from 0 being clear to 3 being most severe lesion.
Time Frame Baseline, visit 8
Hide Outcome Measure Data
Hide Analysis Population Description
Overall number of participants = number of participants completing the study per protocol.
Arm/Group Title A-101 Vehicle A-101 (32.5%) Topical Solution A-101 (40%) Topical Solution
Hide Arm/Group Description:

A-101 Vehicle (placebo) Topical Solution

A-101 Vehicle: Placebo control

A-101 (32.5%) Topical Solution - low dose

A-101 (32.5%) Topical Solution: A-101 (32.5%) Topical Solution - low dose

A-101 (40%) Topical Solution - high dose

A-101 (40%) Topical Solution: A-101 (40%) Topical Solution - high dose

Overall Number of Participants Analyzed 57 56 56
Overall Number of Units Analyzed
Type of Units Analyzed: Lesions
228 224 224
Mean (Standard Deviation)
Unit of Measure: percentage of lesions cleared
4.82  (15.26) 26.79  (38.10) 45.09  (37.06)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection A-101 Vehicle, A-101 (32.5%) Topical Solution
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0003
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection A-101 Vehicle, A-101 (40%) Topical Solution
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .0001
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
2.Secondary Outcome
Title Mean Change From Baseline to Visit 8 in the Physician's Lesion Assessment
Hide Description

Change from baseline PLA will be calculated for each lesion first, then per-subject mean changes from baseline will be calculated.

The PLA is a score on a four scale from 0 to 3 with 0 being clear and 3 being the most severe, a lower score indicating a better result. For the mean change in this score, a larger mean change is a better result.

Time Frame Baseline, visit 8
Hide Outcome Measure Data
Hide Analysis Population Description
N = number of participants completing the protocol.
Arm/Group Title A-101 Vehicle A-101 (32.5%) Topical Solution A-101 (40%) Topical Solution
Hide Arm/Group Description:

A-101 Vehicle (placebo) Topical Solution

A-101 Vehicle: Placebo control

A-101 (32.5%) Topical Solution - low dose

A-101 (32.5) Topical Solution: A-101 (32.5) Topical Solution - low dose

A-101 (40%) Topical Solution - high dose

A-101 (40) Topical Solution: A-101 (40) Topical Solution - high dose

Overall Number of Participants Analyzed 57 56 56
Overall Number of Units Analyzed
Type of Units Analyzed: Lesions
228 224 224
Mean (Standard Deviation)
Unit of Measure: units on a scale
-0.32  (0.57) -0.77  (0.67) -0.91  (0.77)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection A-101 Vehicle, A-101 (32.5%) Topical Solution
Comments mean change from baseline to Visit 8 PLA will be performed using Analysis of Covariance (ANCOVA) with baseline PLA as the covariate.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection A-101 Vehicle, A-101 (40%) Topical Solution
Comments mean change from baseline to Visit 8 PLA will be performed using Analysis of Covariance (ANCOVA) with baseline PLA as the covariate.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
3.Secondary Outcome
Title Proportion of Subjects Who Had at Least 3 of 4 Target Lesions Judged to be Clear on the Physician Lesion Assessment (PLA =0) at Visit 8.
Hide Description Proportion of Subjects who had at least 3 of 4 target lesions judged to be clear on the Physician Lesion Assessment (PLA =0) at visit 8. The PLA is a 4 point scale evaluating the severity of a lesion with 0 being clear and 3 being the most severe.
Time Frame Baseline, visit 8
Hide Outcome Measure Data
Hide Analysis Population Description
N = number of subjects who completed the study per protocol.
Arm/Group Title A-101 Vehicle A-101 (32.5%) Topical Solution A-101 (40%) Topical Solution
Hide Arm/Group Description:

A-101 Vehicle (placebo) Topical Solution

A-101 Vehicle: Placebo control

A-101 (32.5%) Topical Solution - low dose

A-101 (32.5) Topical Solution: A-101 (32.5) Topical Solution - low dose

A-101 (40%) Topical Solution - high dose

A-101 (40) Topical Solution: A-101 (40) Topical Solution - high dose

Overall Number of Participants Analyzed 57 56 56
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
9
  16.1%
11
  19.6%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection A-101 Vehicle, A-101 (32.5%) Topical Solution
Comments

Secondary efficacy analyses will also be conducted based on the proportion of subjects who have at least 3 of 4 target lesions judged to be clear on the PLA (PLA=0) at Visit 8.

A separate comparison will be made between each active treatment group and the vehicle treatment group using Cochran-Mantel-Haenszel (CMH) tests stratified by site.

Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0016
Comments For all analyses, two-tail alpha will be set to 0.05 with no adjustment for multiple comparisons.
Method Cochran-Mantel-Haenszel
Comments For all analyses, two-tail alpha will be set to 0.05 with no adjustment for multiple comparisons.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection A-101 Vehicle, A-101 (40%) Topical Solution
Comments [Not Specified]
Type of Statistical Test Other
Comments For all analyses, two-tail alpha will be set to 0.05 with no adjustment for multiple comparisons.
Statistical Test of Hypothesis P-Value 0.0004
Comments For all analyses, two-tail alpha will be set to 0.05 with no adjustment for multiple comparisons.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Time Frame From subject's first study medication application to the end of the study (visit 8), up to 106 days. the end of the subject’s last visit. 106.
Adverse Event Reporting Description An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a study medication(s) and which does not necessarily have a causal relationship with the study medication. Thus any new, clinically relevant worsening of an existing sign, symptom or disease, should be considered an AE.
 
Arm/Group Title A-101 Vehicle A-101 (32.5%) Topical Solution A-101 (40%) Topical Solution
Hide Arm/Group Description

A-101 Vehicle (placebo) Topical Solution

A-101 Vehicle: Placebo control

A-101 (32.5%) Topical Solution - low dose

A-101 (32.5%) Topical Solution: A-101 (32.5%) Topical Solution - low dose

A-101 (40%) Topical Solution - high dose

A-101 (40%) Topical Solution: A-101 (40%) Topical Solution - high dose

All-Cause Mortality
A-101 Vehicle A-101 (32.5%) Topical Solution A-101 (40%) Topical Solution
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/58 (0.00%)   0/57 (0.00%)   0/57 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
A-101 Vehicle A-101 (32.5%) Topical Solution A-101 (40%) Topical Solution
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/58 (1.72%)   0/57 (0.00%)   2/57 (3.51%) 
Cardiac disorders       
Atrial Fibrillation  1  0/58 (0.00%)  0/57 (0.00%)  1/57 (1.75%) 
Injury, poisoning and procedural complications       
Laceration  1 [1]  0/58 (0.00%)  0/57 (0.00%)  1/57 (1.75%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Breast Cancer  1 [2]  1/58 (1.72%)  0/57 (0.00%)  0/57 (0.00%) 
1
Term from vocabulary, MedDRA (14.1)
Indicates events were collected by systematic assessment
[1]
right leg laceration
[2]
Invasive ductal carcinoma
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
A-101 Vehicle A-101 (32.5%) Topical Solution A-101 (40%) Topical Solution
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   15/58 (25.86%)   9/57 (15.79%)   17/57 (29.82%) 
Gastrointestinal disorders       
Constipation  1  0/58 (0.00%)  1/57 (1.75%)  0/57 (0.00%) 
Diarrhoea  1  0/58 (0.00%)  0/57 (0.00%)  1/57 (1.75%) 
Gastroesophageal reflux disease  1  0/58 (0.00%)  1/57 (1.75%)  0/57 (0.00%) 
Toothache  1  0/58 (0.00%)  0/57 (0.00%)  2/57 (3.51%) 
General disorders       
Axillary Pain  1  1/58 (1.72%)  0/57 (0.00%)  0/57 (0.00%) 
Pain  1  0/58 (0.00%)  2/57 (3.51%)  0/57 (0.00%) 
Immune system disorders       
Rhinitis allergic  1  1/58 (1.72%)  0/57 (0.00%)  0/57 (0.00%) 
Seasonal allergy  1  2/58 (3.45%)  1/57 (1.75%)  0/57 (0.00%) 
Infections and infestations       
Bronchitis  1  0/58 (0.00%)  0/57 (0.00%)  1/57 (1.75%) 
Cystitis  1  1/58 (1.72%)  0/57 (0.00%)  0/57 (0.00%) 
Ear infection  1  1/58 (1.72%)  0/57 (0.00%)  0/57 (0.00%) 
Nasopharyngitis  1  0/58 (0.00%)  0/57 (0.00%)  2/57 (3.51%) 
Sinusitis  1  0/58 (0.00%)  1/57 (1.75%)  1/57 (1.75%) 
Tinea Cruris  1  1/58 (1.72%)  0/57 (0.00%)  0/57 (0.00%) 
Tooth infection  1  0/58 (0.00%)  0/57 (0.00%)  1/57 (1.75%) 
Upper respiratory tract infection  1  1/58 (1.72%)  0/57 (0.00%)  2/57 (3.51%) 
Viral upper respiratory infection  1  0/58 (0.00%)  0/57 (0.00%)  1/57 (1.75%) 
Vulvovaginal mycotic infection  1  0/58 (0.00%)  0/57 (0.00%)  1/57 (1.75%) 
Injury, poisoning and procedural complications       
Arthropod bite  1  0/58 (0.00%)  0/57 (0.00%)  1/57 (1.75%) 
Arthropod sting  1  0/58 (0.00%)  1/57 (1.75%)  0/57 (0.00%) 
Excoriation  1  1/58 (1.72%)  0/57 (0.00%)  0/57 (0.00%) 
Fall  1  0/58 (0.00%)  0/57 (0.00%)  1/57 (1.75%) 
Investigations       
Blood glucose increase  1  0/58 (0.00%)  0/57 (0.00%)  1/57 (1.75%) 
Glycosylated haemoglobin increased  1  1/58 (1.72%)  0/57 (0.00%)  1/57 (1.75%) 
Metabolism and nutrition disorders       
Oedema Peripheral  1  0/58 (0.00%)  0/57 (0.00%)  1/57 (1.75%) 
Musculoskeletal and connective tissue disorders       
Arthritis  1  4/58 (6.90%)  0/57 (0.00%)  0/57 (0.00%) 
Back pain  1  2/58 (3.45%)  1/57 (1.75%)  2/57 (3.51%) 
Ligament sprain  1  1/58 (1.72%)  0/57 (0.00%)  0/57 (0.00%) 
Musculoskeletal Pain  1  1/58 (1.72%)  0/57 (0.00%)  0/57 (0.00%) 
Osteoarthritis  1  0/58 (0.00%)  0/57 (0.00%)  1/57 (1.75%) 
Pain in extremity  1  1/58 (1.72%)  0/57 (0.00%)  1/57 (1.75%) 
Pain in Jaw  1  0/58 (0.00%)  0/57 (0.00%)  1/57 (1.75%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Head and neck cancer  1  0/58 (0.00%)  1/57 (1.75%)  0/57 (0.00%) 
Squamous cell carcinoma  1  1/58 (1.72%)  0/57 (0.00%)  0/57 (0.00%) 
Nervous system disorders       
Headache  1  2/58 (3.45%)  0/57 (0.00%)  0/57 (0.00%) 
Insomnia  1  0/58 (0.00%)  0/57 (0.00%)  1/57 (1.75%) 
Psychiatric disorders       
Dementia  1  0/58 (0.00%)  1/57 (1.75%)  0/57 (0.00%) 
Renal and urinary disorders       
Nephrolithiasis  1  1/58 (1.72%)  0/57 (0.00%)  0/57 (0.00%) 
Urinary tract infection  1  0/58 (0.00%)  1/57 (1.75%)  1/57 (1.75%) 
Respiratory, thoracic and mediastinal disorders       
Asthma  1  0/58 (0.00%)  2/57 (3.51%)  0/57 (0.00%) 
Chronic obstructive pulmonary disease  1  0/58 (0.00%)  1/57 (1.75%)  0/57 (0.00%) 
Nasal congestion  1  0/58 (0.00%)  0/57 (0.00%)  1/57 (1.75%) 
Oropharyngeal pain  1  1/58 (1.72%)  0/57 (0.00%)  0/57 (0.00%) 
Skin and subcutaneous tissue disorders       
Blepharitis  1  0/58 (0.00%)  0/57 (0.00%)  1/57 (1.75%) 
Contusion  1  0/58 (0.00%)  1/57 (1.75%)  0/57 (0.00%) 
Dermatitis contact  1  0/58 (0.00%)  1/57 (1.75%)  0/57 (0.00%) 
Pain of skin  1  0/58 (0.00%)  0/57 (0.00%)  1/57 (1.75%) 
Sunburn  1  1/58 (1.72%)  0/57 (0.00%)  0/57 (0.00%) 
Surgical and medical procedures       
Acrochordon excision  1  0/58 (0.00%)  0/57 (0.00%)  1/57 (1.75%) 
Cyst removal  1  1/58 (1.72%)  0/57 (0.00%)  0/57 (0.00%) 
Injection  1  0/58 (0.00%)  0/57 (0.00%)  1/57 (1.75%) 
Skin neoplasm excision  1  0/58 (0.00%)  0/57 (0.00%)  1/57 (1.75%) 
Vascular disorders       
Migraine  1  0/58 (0.00%)  1/57 (1.75%)  0/57 (0.00%) 
1
Term from vocabulary, MedDRA (14.1)
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 investigators agree to not publish the results of this study without the permission of the sponsor.
Results Point of Contact
Name/Title: Judith Schnyder
Organization: Aclaris Therapeutics Inc.
Phone: +1-484-329-2144
Responsible Party: Aclaris Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT02160626     History of Changes
Other Study ID Numbers: A-101-SEBK-202
First Submitted: June 6, 2014
First Posted: June 11, 2014
Results First Submitted: September 30, 2018
Results First Posted: December 7, 2018
Last Update Posted: January 3, 2019