A Randomized, Vehicle-Controlled Study of 2 Concentrations of A-101 for the Treatment of Seborrheic Keratosis

NCT03148691 | Completed Phase 2 Results FDA Drug

• 1 other identifier: A-101-SEBK-204
• Study Type: interventional
• Target: 253
• Locations: 1 country
• Sites: 9

Brief Summary

The primary objective of this study is to evaluate the safety and effectiveness of 2 concentrations of A-101 compared to Vehicle for the treatment of 4 seborrheic keratosis (SK) Target Lesions on the trunk, extremities and face.

Conditions

Seborrheic Keratosis

Outcome Measures

Primary Outcomes (1)

• Mean of Per Subject Percentages of Target Lesions Judged to be Clear (PWA=0) at Visit 8

  Mean of per subject percentages of target lesions judged to be clear (PWA=0) at Visit 8 Grade Descriptor 0 Clear: no visible seborrheic keratosis lesion 1. Near Clear: a visible seborrheic keratosis lesion with a surface appearance different from the surrounding skin (not elevated) 2. Thin: a visible seborrheic keratosis lesion (thickness ≤ 1 mm) 3. Thick: a visible seborrheic keratosis lesion (thickness \> 1 mm)

  Day 106

Study Arms (3)

Vehicle

PLACEBO COMPARATOR

Vehicle Topical Solution

Drug: A-101

A-101 Low Dose

ACTIVE COMPARATOR

A-101 Low Dose Topical Solution

Drug: A-101

A-101 High Dose

ACTIVE COMPARATOR

A-101 High DoseTopical Solution

Drug: A-101

Interventions

A-101 DRUG

Topical Solution

A-101 High Dose; A-101 Low Dose; Vehicle

Eligibility Criteria

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

You may qualify if:

• Subject is able to comprehend and is willing to sign an informed consent for participation in this study.
• Male or female ≥ 18 years old.
• Subject has a clinical diagnosis of stable clinically typical seborrheic keratosis.
• Subject has 4 appropriate seborrheic keratosis Target Lesions on the trunk, extremities and face, with at least 1 Target Lesion on the face and at least 1 Target Lesion on the trunk or extremities. The 4 identified Target Lesions must meet the requirements as defined below:
• Have a clinically typical appearance
• Have a Physician's Lesion Assessment of ≥ 2
• Length that is ≥ 5mm and ≤ 15mm
• Width that is ≥ 5mm and ≤ 15 mm
• Thickness that is ≤ 2mm
• Be a discrete lesion
• Be the only SK lesion present when centered in the area outlined by the provided circular template
• Not be covered with hair which, the in the investigator's opinion, would interfere with the study medication treatment or the study evaluations
• Not be in the intertriginous fold
• Not be on the eyelids
• Not be within 5mm of the orbital rim

You may not qualify if:

• Subject has clinically atypical and /or rapidly growing seborrheic keratosis lesions.
• Subject has presence of multiple eruptive seborrheic keratosis lesions (Sign of Leser - Trelat).
• Subject has current systemic malignancy.
• Subject has used any of the following systemic therapies within the specified period prior to Visit 1:
• Retinoids; 180 days
• Corticosteroids; 28 days
• Anti-metabolites (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, photo-dynamic therapy; 180 days
• Liquid nitrogen, electrodesiccation, curettage, imiquimod, 5-Fluorouracil, or ingenol mebutate; 60 days
• Hydrogen peroxide: 90 days
• Retinoids; 28 days
• Microdermabrasion or superficial chemical peels; 14 days
• Corticosteroids or antibiotics; 14 days
• Subject would require the use of any topical treatment (e.g. moisturizers, sunscreen) to any of the Target Lesions 12 hours prior to any study visit.

Sponsors & Collaborators

• Aclaris Therapeutics, Inc.: lead

Study Sites (9)

Center for Dermatology and Dermatologic Surgery

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

Location

Baumann Research Institute

Miami, Florida, 33137, United States

Location

MedaPhase, Inc

Newnan, Georgia, 30263, United States

Location

Union Square Laser Dermatology

New York, New York, 10003, United States

Location

Philadelphia Institute - Dermatology

Fort Washington, Pennsylvania, 19034, United States

Location

Perelman Center for Advanced Medicine

Philadelphia, Pennsylvania, 19104, United States

Location

Greenville Dermatology

Greenville, South Carolina, 29607, United States

Location

The Skin Wellness Center, PC Clinical Research Division

Knoxville, Tennessee, 37922, United States

Location

DermResearch Inc

Austin, Texas, 78759, United States

Location

MeSH Terms

Conditions

Keratosis, Seborrheic

Interventions

N-phenylacetoaminomethylene-DL-p-nitrophenylalanine

Condition Hierarchy (Ancestors)

Keratosis; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

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

jschnyder@aclaristx.com

4843247933

Study Officials

• Stuart D Shanler, MD

  Aclaris Therapeutics, Inc.

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2017
• First Posted: May 11, 2017
• Study Start: May 17, 2017
• Primary Completion: February 28, 2018
• Study Completion: April 3, 2018
• Last Updated: May 6, 2019
• Results First Posted: May 6, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (9)