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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.

Tracking Information
First Submitted Date  ICMJE July 5, 2017
First Posted Date  ICMJE July 21, 2017
Results First Submitted Date  ICMJE January 14, 2020
Results First Posted Date  ICMJE February 10, 2020
Last Update Posted Date March 30, 2020
Actual Study Start Date  ICMJE June 26, 2017
Actual Primary Completion Date January 8, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 27, 2020)
Physician's DPN Lesions Assessment [ Time Frame: Day 106 ]
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
Original Primary Outcome Measures  ICMJE
 (submitted: July 19, 2017)
Physician's DPN Lesions Assessment [ Time Frame: Day 106 ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of A-101 Topical Solution in Subjects With Dermatosis Papulosa Nigra
Official Title  ICMJE A Phase 2 Open Label Study of A-101 Topical Solution in Subjects With Dermatosis Papulosa Nigra
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Treatment
Condition  ICMJE Dermatosis Papulosa Nigra
Intervention  ICMJE Drug: A-101 Topical Solution 40%
A-101 Topical Solution 40%
Study Arms  ICMJE
  • Experimental: No medical abrading
    A-101 40% without medically abrading the identified DPN prior to treatment
    Intervention: Drug: A-101 Topical Solution 40%
  • Experimental: Medically abrading
    A-101 40% with the identified DPN lesions medically abraded prior to treatment
    Intervention: Drug: A-101 Topical Solution 40%
  • Experimental: Initial cohort - no medical abrading
    A-101 40% without medically abrading the identified DPN prior to treatment
    Intervention: Drug: A-101 Topical Solution 40%
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 2, 2019)
39
Original Estimated Enrollment  ICMJE
 (submitted: July 19, 2017)
12
Actual Study Completion Date  ICMJE January 8, 2019
Actual Primary Completion Date January 8, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03224598
Other Study ID Numbers  ICMJE A-101-DPN-201
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Aclaris Therapeutics, Inc.
Study Sponsor  ICMJE Aclaris Therapeutics, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Aclaris Therapeutics, Inc.
Verification Date February 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP