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

Primary Purpose

Dermatosis Papulosa Nigra

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
A-101 Topical Solution 40%
Sponsored by
Aclaris Therapeutics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dermatosis Papulosa Nigra

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Provisions of written informed consent for participation in this study.
  2. Male or female ≥ 18 years old.
  3. Subject has a clinical diagnosis of dermatosis papulose nigra.
  4. Fitzpatrick Skin Type of 5 or 6
  5. Subject has 4 target DPN lesions located in an area that has not been previously treated.
  6. Subject chemistry and complete blood count results are within normal limits for the central laboratory.
  7. Woman of childbearing potential must have a negative urine pregnancy test within 14 days of the first application of study drug and agree to use an active method of birth control for the duration of the study
  8. Subject is non-pregnant and non-lactating.
  9. Subject is in good general health and free of any known disease state or physical condition.
  10. Subject is willing and able to follow all study instructions and to attend all study visits.

Exclusion Criteria:

  1. Subject has clinically atypical and /or rapidly growing DPN lesion.
  2. Subject has current systemic malignancy.
  3. Subject has a history of keloids
  4. Subject has a history of post inflammatory hyperpigmentation lasting longer than 1 year.

  5. Subject has used any of the following systemic therapies within the specified period prior to Visit 1:

    • Retinoids; 180 days
    • Corticosteroids; 28 days
    • Antimetabolites (e.g., methotrexate); 28 days

  6. 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:

    • LASER, light or other energy based therapy (e.g., intense pulsed light [IPL], photo-dynamic therapy [PDT]; 180 days
    • Liquid nitrogen, electrodesiccation, curettage, imiquimod, 5-fluoruracil (5FU), or ingenol mebutate; 60 days
    • Retinoids; 28 days
    • Microdermabrasion or superficial chemical peels; 14 days
    • Corticosteroids or antibiotics; 14 days.

  7. 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:

    • Cutaneous malignancy; 180 days
    • Sunburn; currently
    • Pre-malignancy (e.g. actinic keratosis); currently
    • Body art (e.g. tattoos, piercing, etc.); currently
    • Excessive tan. The use of self-tanning lotions/sprays are prohibited.
  8. Subject has a history of sensitivity to any of the ingredients in the study medications.
  9. 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.
  10. Participation in another therapeutic investigational drug trial in which administration of an investigational study medication occurred with 30 days prior to Visit 1.

Sites / Locations

  • Aclaris Investigational Site
  • Aclaris Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

No medical abrading

Medically abrading

Initial cohort - no medical abrading

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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; Near Clear: a slightly visible DPN lesion; lesion may be macular Small: a visible DPN lesion with a diameter of less than 3 mm Large : a visible DPN lesion that is elevated with a diameter of ≥3 mm

Secondary Outcome Measures

Full Information

First Posted
July 5, 2017
Last Updated
March 16, 2020
Sponsor
Aclaris Therapeutics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03224598
Brief Title
A Study of A-101 Topical Solution in Subjects With Dermatosis Papulosa Nigra
Official Title
A Phase 2 Open Label Study of A-101 Topical Solution in Subjects With Dermatosis Papulosa Nigra
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
June 26, 2017 (Actual)
Primary Completion Date
January 8, 2019 (Actual)
Study Completion Date
January 8, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Aclaris Therapeutics, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
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: Durability of response Safety 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dermatosis Papulosa Nigra

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
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: A-101 40% without medically abrading the identified DPN prior to treatment A-101 40% with the identified DPN lesions medically abraded prior to treatment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
39 (Actual)

8. Arms, Groups, and Interventions

Arm Title
No medical abrading
Arm Type
Experimental
Arm Description
A-101 40% without medically abrading the identified DPN prior to treatment
Arm Title
Medically abrading
Arm Type
Experimental
Arm Description
A-101 40% with the identified DPN lesions medically abraded prior to treatment
Arm Title
Initial cohort - no medical abrading
Arm Type
Experimental
Arm Description
A-101 40% without medically abrading the identified DPN prior to treatment
Intervention Type
Drug
Intervention Name(s)
A-101 Topical Solution 40%
Intervention Description
A-101 Topical Solution 40%
Primary Outcome Measure Information:
Title
Physician's DPN Lesions Assessment
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; Near Clear: a slightly visible DPN lesion; lesion may be macular Small: a visible DPN lesion with a diameter of less than 3 mm Large : a visible DPN lesion that is elevated with a diameter of ≥3 mm
Time Frame
Day 106

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Provisions of written informed consent for participation in this study. Male or female ≥ 18 years old. Subject has a clinical diagnosis of dermatosis papulose nigra. Fitzpatrick Skin Type of 5 or 6 Subject has 4 target DPN lesions located in an area that has not been previously treated. Subject chemistry and complete blood count results are within normal limits for the central laboratory. Woman of childbearing potential must have a negative urine pregnancy test within 14 days of the first application of study drug and agree to use an active method of birth control for the duration of the study Subject is non-pregnant and non-lactating. Subject is in good general health and free of any known disease state or physical condition. Subject is willing and able to follow all study instructions and to attend all study visits. 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: Retinoids; 180 days Corticosteroids; 28 days Antimetabolites (e.g., methotrexate); 28 days 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: LASER, light or other energy based therapy (e.g., intense pulsed light [IPL], photo-dynamic therapy [PDT]; 180 days Liquid nitrogen, electrodesiccation, curettage, imiquimod, 5-fluoruracil (5FU), or ingenol mebutate; 60 days Retinoids; 28 days Microdermabrasion or superficial chemical peels; 14 days Corticosteroids or antibiotics; 14 days. 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: Cutaneous malignancy; 180 days Sunburn; currently Pre-malignancy (e.g. actinic keratosis); currently Body art (e.g. tattoos, piercing, etc.); currently Excessive tan. The use of self-tanning lotions/sprays are prohibited. 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.
Facility Information:
Facility Name
Aclaris Investigational Site
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20037
Country
United States
Facility Name
Aclaris Investigational Site
City
New York
State/Province
New York
ZIP/Postal Code
10155
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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