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

NCT03224598 | Completed Phase 2 Results FDA Drug

• 1 other identifier: A-101-DPN-201
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 2

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.

Conditions

Dermatosis Papulosa Nigra

Outcome Measures

Primary Outcomes (1)

• 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; 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

  Day 106

Study Arms (3)

No medical abrading

EXPERIMENTAL

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

Drug: A-101 Topical Solution 40%

Medically abrading

EXPERIMENTAL

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

Drug: A-101 Topical Solution 40%

Initial cohort - no medical abrading

EXPERIMENTAL

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

Drug: A-101 Topical Solution 40%

Interventions

A-101 Topical Solution 40% DRUG

A-101 Topical Solution 40%

Initial cohort - no medical abrading; Medically abrading; No medical abrading

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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:

Sponsors & Collaborators

• Aclaris Therapeutics, Inc.: lead

Study Sites (2)

Aclaris Investigational Site

Washington D.C., District of Columbia, 20037, United States

Location

Aclaris Investigational Site

New York, New York, 10155, United States

Location

MeSH Terms

Conditions

Dermatosis Papulosa Nigra

Results Point of Contact

• Title: Executive Director Clinical Operations
• Organization: Aclaris Therapeutics

jschnyder@aclaristx.com

4843247933

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: July 5, 2017
• First Posted: July 21, 2017
• Study Start: June 26, 2017
• Primary Completion: January 8, 2019
• Study Completion: January 8, 2019
• Last Updated: March 30, 2020
• Results First Posted: March 17, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)