Spots Global Cancer Trial Database for A Randomized, Vehicle-Controlled Study of 2 Concentrations of A-101 for the Treatment of Seborrheic Keratosis
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Trial Identification
Brief Title: A Randomized, Vehicle-Controlled Study of 2 Concentrations of A-101 for the Treatment of Seborrheic Keratosis
Official Title: 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
Study ID: NCT03148691
Conditions
Interventions
Study Description
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.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Center for Dermatology and Dermatologic Surgery, Washington, District of Columbia, United States
Baumann Research Institute, Miami, Florida, United States
MedaPhase, Inc, Newnan, Georgia, United States
Union Square Laser Dermatology, New York, New York, United States
Philadelphia Institute - Dermatology, Fort Washington, Pennsylvania, United States
Perelman Center for Advanced Medicine, Philadelphia, Pennsylvania, United States
Greenville Dermatology, Greenville, South Carolina, United States
The Skin Wellness Center, PC Clinical Research Division, Knoxville, Tennessee, United States
DermResearch Inc, Austin, Texas, United States
Contact Details
Name: Stuart D Shanler, MD
Affiliation: Aclaris Therapeutics, Inc.
Role: STUDY_DIRECTOR
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