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

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ClinicalTrials.gov Identifier: NCT03224598
Recruitment Status : Active, not recruiting
First Posted : July 21, 2017
Last Update Posted : October 3, 2018
Sponsor:
Information provided by (Responsible Party):
Aclaris Therapeutics, Inc.

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.

Condition or disease Intervention/treatment Phase
Dermatosis Papulosa Nigra Drug: A-101 Topical Solution 40% Phase 2

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2 Open Label, Single Arm Pilot Study of A-101 Topical Solution in Subjects With Dermatosis Papulosa Nigra
Actual Study Start Date : June 26, 2017
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Skin Conditions

Arm Intervention/treatment
Experimental: Open-Label
A-101 Topical Solution 40%
Drug: A-101 Topical Solution 40%
A-101 Topical Solution 40%




Primary Outcome Measures :
  1. Physician's DPN Lesions Assessment [ Time Frame: Day 106 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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. Subject chemistry and complete blood count results are within normal limits for the central laboratory. If any of the laboratory values are outside normal limits, the treating investigator must assess the value/s as not clinically significant and document this in the patient's source documents.
  5. 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
  6. Subject is non-pregnant and non-lactating.
  7. Subject is in good general health and free of any known disease state or physical condition which, in the investigator's opinion, might impair the evaluation of any Target DPN Lesions or which exposes the subject to an unacceptable risk by study participation.
  8. 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-flurouracil (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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03224598


Locations
United States, District of Columbia
Aclaris Investigational Site
Washington, District of Columbia, United States, 20037
United States, New York
Aclaris Investigational Site
New York, New York, United States, 10155
Sponsors and Collaborators
Aclaris Therapeutics, Inc.

Responsible Party: Aclaris Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT03224598     History of Changes
Other Study ID Numbers: A-101-DPN-201
First Posted: July 21, 2017    Key Record Dates
Last Update Posted: October 3, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Skin Diseases
Skin Diseases, Papulosquamous
Pharmaceutical Solutions