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Evaluate the safety and efficacy of hydrogen peroxide, A-101 Solution 40% for the treatment of DPN lesions on subjects with a Fitzpatrick Skin Type of 5 or 6.
The main objective of this study is to evaluate the safety and efficacy of hydrogen peroxide, A-101 Solution 40% for the treatment of DPN lesions on subjects with a Fitzpatrick Skin Type of 5 or 6.
The secondary objectives of this study include:
An exploratory objective of this study will evaluate the subject's assessment of the treatment of A-101 to DPN lesions using a Subject Self-Assessment Scale.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| No medical abrading | Experimental | A-101 40% without medically abrading the identified DPN prior to treatment |
|
| Medically abrading | Experimental | A-101 40% with the identified DPN lesions medically abraded prior to treatment |
|
| Initial cohort - no medical abrading | Experimental | A-101 40% without medically abrading the identified DPN prior to treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| A-101 Topical Solution 40% | Drug | A-101 Topical Solution 40% |
|
| Measure | Description | Time Frame |
|---|---|---|
| Physician's DPN Lesions Assessment | 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;
| Day 106 |
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Inclusion Criteria:
Exclusion Criteria:
Subject has clinically atypical and /or rapidly growing DPN lesion.
Subject has current systemic malignancy.
Subject has a history of keloids
Subject has a history of post inflammatory hyperpigmentation lasting longer than 1 year.
Subject has used any of the following systemic therapies within the specified period prior to Visit 1:
Subject has used any of the following topical therapies within the specified period prior to Visit 1 on, or in a proximity to any Target Lesion, that in the investigator's opinion interferes with the study medication treatment or the study assessments:
Subject currently has or has had any of the following within the specified period prior to Visit 1 on or in a proximity to any Target Lesion that, in the investigator's opinion, interferes with the study medication treatment or the study assessments:
Subject has a history of sensitivity to any of the ingredients in the study medications.
Subject has any current skin disease (e.g. psoriasis, atopic dermatitis, eczema, sun damage), or condition (e.g. sunburn, excessive hair, open wounds) that, in the opinion of the investigator, might put the subject at undue risk by study participation or interfere with the study conduct or evaluations.
Participation in another therapeutic investigational drug trial in which administration of an investigational study medication occurred with 30 days prior to Visit 1.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aclaris Investigational Site | Washington D.C. | District of Columbia | 20037 | United States | ||
| Aclaris Investigational Site |
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| ID | Title | Description |
|---|---|---|
| FG000 | No Medical Abrading | A-101 40% without medically abrading the identified DPN prior to treatment A-101 Topical Solution 40%: A-101 Topical Solution 40% |
| FG001 | Medically Abrading | A-101 40% with the identified DPN lesions medically abraded prior to treatment A-101 Topical Solution 40%: A-101 Topical Solution 40% |
| FG002 | Initial Cohort - no Medical Abrading | initial cohort no medical abrading different treatment schedule |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | No Medical Abrading | A-101 40% without medically abrading the identified DPN prior to treatment A-101 Topical Solution 40%: A-101 Topical Solution 40% |
| BG001 | Medically Abrading |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Physician's DPN Lesions Assessment | 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;
| per-protocol | Posted | Mean | Standard Deviation | score on a scale (PLA) | Day 106 |
|
106 days
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
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | No Medical Abrading | A-101 40% without medically abrading the identified DPN prior to treatment A-101 Topical Solution 40%: A-101 Topical Solution 40% |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| eye pain | Eye disorders | MedDRA (21.1) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Executive Director Clinical Operations | Aclaris Therapeutics | 4843247933 | jschnyder@aclaristx.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 28, 2018 | Jan 14, 2020 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 19, 2019 | Jan 14, 2020 | SAP_001.pdf |
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| ID | Term |
|---|---|
| C562379 | Dermatosis Papulosa Nigra |
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The first cohort of the study will enroll a total of 12 subjects. In the second part of the study, subjects will be a randomized to additional two-arm cohorts. Subjects will be randomized to one of the following 2 treatment arms:
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| New York |
| New York |
| 10155 |
| United States |
A-101 40% with the identified DPN lesions medically abraded prior to treatment
A-101 Topical Solution 40%: A-101 Topical Solution 40%
| BG002 | Initial Cohort - no Medical Abrading | 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 |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Fitzpatrick Skin Type | Count of Participants | Participants |
|
| OG001 | Medically Abrading | A-101 40% with the identified DPN lesions medically abraded prior to treatment A-101 Topical Solution 40%: A-101 Topical Solution 40% |
| OG002 | Initial Cohort - no Medical Abrading | initial cohort no medical abrading different treatment schedule |
|
|
| 0 |
| 9 |
| 0 |
| 9 |
| 1 |
| 9 |
| EG001 | Medically Abrading | A-101 40% with the identified DPN lesions medically abraded prior to treatment A-101 Topical Solution 40%: A-101 Topical Solution 40% | 0 | 17 | 0 | 17 | 2 | 17 |
| EG002 | Initial Cohort - no Medical Abrading | initial cohort no medical abrading different treatment schedule | 0 | 13 | 0 | 13 | 1 | 13 |
| Lacrimation increased | Eye disorders | MedDRA (21.1) | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA (21.1) | Systematic Assessment |
|
| Muscle strain | Musculoskeletal and connective tissue disorders | MedDRA (21.1) | Systematic Assessment |
|
| headache | Nervous system disorders | MedDRA (21.1) | Systematic Assessment |
|
| Rash vesicular | Skin and subcutaneous tissue disorders | MedDRA (21.1) | Systematic Assessment |
|
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