A Phase 2 Randomized, Double-Blind, Vehicle-Controlled, Parallel Group Study of the Safety and Effectiveness of A-101(Hydrogen Peroxide) Topical Solution in Subjects With Seborrheic Keratosis Lesions on the Trunk, Extremities, and Face
Overview
- Phase
- Phase 2
- Intervention
- A-101
- Conditions
- Seborrheic Keratosis
- Sponsor
- Aclaris Therapeutics, Inc.
- Enrollment
- 253
- Locations
- 9
- Primary Endpoint
- Mean of Per Subject Percentages of Target Lesions Judged to be Clear (PWA=0) at Visit 8
- Status
- Completed
- Last Updated
- 6 years ago
Overview
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.
Detailed Description
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. The secondary objectives of this study include duration of response of A-101. During the study, the investigator will identify 4 eligible SK Target Lesions on each subject on the trunk, extremities and face. For each subject, at least 1 SK Target Lesion must be on the face and at least 1 Target Lesion must be on the trunk or extremities. The Target Lesions will be treated at a maximum of two treatment visits.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Arms & Interventions
Vehicle
Vehicle Topical Solution
Intervention: A-101
A-101 Low Dose
A-101 Low Dose Topical Solution
Intervention: A-101
A-101 High Dose
A-101 High DoseTopical Solution
Intervention: A-101
Outcomes
Primary Outcomes
Mean of Per Subject Percentages of Target Lesions Judged to be Clear (PWA=0) at Visit 8
Time Frame: Day 106
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)