Study of A-101 for the Treatment of Seborrheic Keratosis

NCT02260180 | Completed Phase 2 Results

• 1 other identifier: A-101-SEBK-203
• Study Type: interventional
• Target: 119
• Locations: 1 country
• Sites: 4

Brief Summary

The purpose of this study is to evaluate the safety and dose-response of 2 concentrations of A-101 versus a vehicle control in the treatment of seborrheic keratosis.

Conditions

Seborrheic Keratosis

Outcome Measures

Primary Outcomes (1)

• Percentage of PLA Responders With Target Lesion Clear (PLA = 0) in Each Arm at Visit 8.

  The primary effectiveness analysis was a comparison between each A-101 group and the vehicle group based on the percentage with target lesions judged to be clear on the PLA (PLA = 0) at Visit 8. The three arms of the study are A-101 40% Topical Solution, A-101 32.5% Topical Solution, and A-101 0% Topical Solution (vehicle). The Physician's Lesion Analysis ( PLA) is a 4 point scale from 0 to 3, with 0 being lesion clear and 3 being the most severe lesion. A larger proportion of subjects with a PLA =0 is better.

  Day 106

Secondary Outcomes (1)

• Mean Change From Baseline PLA Score at Visit 8

  Day 106

Study Arms (3)

A-101 40%

ACTIVE COMPARATOR

A-101 40% Topical Solution

Drug: A-101

A-101 32.5%

ACTIVE COMPARATOR

A-101 32.5% Topical Solution

Drug: A-101

A-101 Vehicle Topical Solution

PLACEBO COMPARATOR

A-101 0% Topical Solution (vehicle)

Drug: A-101

Interventions

A-101 DRUG

Topical Solution

A-101 32.5%; A-101 40%; A-101 Vehicle Topical Solution

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject is at least 18 years of age
• Subject has a Fitzpatrick skin type of 1-4
• Subject has a clinical diagnosis of stable clinically typical seborrheic keratosis
• Subject has 1 appropriate seborrheic keratosis target lesion, as defined below (Section 5.4), on the face:
• Have a clinically typical appearance
• Be treatment naïve
• Have a Physician's Lesion Assessment (PLA) of ≥2 (Section 6.1.2)
• Have a longest axis that is ≥7mm and ≤15mm (Section 5.4)
• Have a longest dimension perpendicular to the longest axis that is ≥7mm and ≤15mm (Section 5.4)
• Have a thickness that is ≤2mm
• Be a discrete lesion
• Be, when centered in the area outlined by the provided 3cm diameter circular template, the only seborrheic keratosis lesion present
• Not be on the eyelids
• Not be within 5mm of the orbital rim
• Not be covered with hair which, in the investigator's opinion, would interfere with the study medication application or the study evaluations (NB: the study medication may bleach hair)

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 a current systemic malignancy
• Subject has a history of keloid formation or hypertrophic scarring
• Subject has used any of the following systemic therapies within the specified period prior to Visit 1:
• Retinoids; 180 days
• Glucocortico-steroids; 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 the target lesion, which in the investigator's opinion, interferes with the application of the study medication or the study assessments:
• LASER, light (e.g., intense pulsed light (IPL), photo-dynamic therapy(PDT)) or other energy based therapy; 180 days
• Retinoids; 28 days
• Liquid nitrogen, electrodesiccation, curettage, imiquimod, 5-fluorouracil, or ingenol mebutate; 60 days
• Glucocortico-steroids 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 the target lesion, which in the investigator's opinion, interferes with the application of the study medication or the study assessments :
• A cutaneous malignancy; 180 days

Sponsors & Collaborators

• Aclaris Therapeutics, Inc.: lead

Study Sites (4)

Oregon Medical Research Center

Portland, Oregon, 97223, United States

Location

Philadelphia Institute of Dermatology

Fort Washington, Pennsylvania, 19034, United States

Location

DermReseach, Inc.

Austin, Texas, 78759, United States

Location

The Education & Research Foundation, Inc.

Lynchburg, Virginia, 24501, 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: Judith Schnyder, Senior Director of Clinical Operations
• Organization: Aclaris Therapeutics, Inc.

jschnyder@aclaristx.com

1-484-329-2144

Study Officials

• Brian Beger, BS

  Aclaris Therapeutics, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

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: October 3, 2014
• First Posted: October 9, 2014
• Study Start: October 1, 2014
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: December 2, 2020
• Results First Posted: December 6, 2018

Record last verified: 2020-11

Locations

US (4)