NCT01986920

Study of Safety, Tolerability and Effectiveness of A-101 in Subjects With Seborrheic Keratosis

A Randomized, Double-Blind, Vehicle-Controlled, Within-Subject, Comparison Study of the Safety, Tolerability, And Effectiveness of A-101 Topical Solution in Subjects With Seborrheic Keratosis

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: Aclaris Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Evaluate the safety, tolerability of A-101 when applied to seborrheic keratosis lesions on the back of subjects.

Detailed description

The main objective of this study is to evaluate the safety, effectiveness and tolerability of three concentrations of A-101 25%, 32.5%, and 40%, when applied to individual seborrheic keratosis target lesions on the back compared with a matching A-101 vehicle.

Conditions

• Seborrheic Keratosis (SK)

Interventions

Type	Name	Description
DRUG	A-101 25%	Low Dose Concentration of A-101 applied to one of 4 Target Lesions
DRUG	A-101 32.5%	Mid Dose Concentration of A-101 applied to one of 4 Target Lesions
DRUG	A-101 40%	High Dose Concentration A-101 applied to one of 4 Target Lesions
DRUG	A-101 Vehicle	Placebo applied to one of 4 Target Lesions

Timeline

• Start date: 2013-10-22
• Primary completion: 2014-02-25
• Completion: 2014-02-25
• First posted: 2013-11-19
• Last updated: 2018-12-11
• Results posted: 2018-12-11

Locations

1 site across 1 country: United States