An A Study Assessing Subject Satisfaction With A-101 Topical Solution for Seborrheic Keratoses

NCT ID: NCT03487588

Last Updated: 2019-10-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 41 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-03-21
• Study Completion Date: 2018-11-14

Brief Summary

This study is an open-label study designed to evaluate subject's satisfaction after treatment of seborrheic keratoses with A-101 40%.

Conditions

Seborrheic Keratosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

A-101 Topical Solution

Open Label Arm

Group Type: EXPERIMENTAL

A-101 Topical Solution

Intervention Type: DRUG

A-101 Topical Solution applied Day 1, Day 15 and Day 29

Interventions

A-101 Topical Solution

A-101 Topical Solution applied Day 1, Day 15 and Day 29

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Subject can comprehend and is willing to sign an informed consent for participation in this study.

2. Male or female between the ages of 30 and 75 years old.

3. Subject has 3 eligible Seborrheic Keratoses; 2 target SKs must be on the face, and the additional 1 target SK must be on the neck or decolletage.

4. Subjects must have had cryosurgery for SK removal within the last 6 months and prior to first treatment with A-101 Topical Solution.

5. Target and non-target SKs must not have been previously treated.

6. Subject is in good general health and free of any known disease state or physical condition which, in the investigator's opinion, might impair the evaluation of any target or non-target SK or which exposes the subject to an unacceptable risk by study participation

Exclusion Criteria

1. Subject has clinically atypical and /or rapidly growing Seborrheic Keratoses.

2. Subject has current systemic malignancy.

3. Subject would require the use of any topical treatment (e.g., moisturizers, sunscreens) to any of the target or non-target SKs 12 hours prior to any study visit.

4. Subject has any current skin disease (e.g., psoriasis, atopic dermatitis, eczema, sun damage), or condition (e.g., sunburn, excessive hair, open wounds) that, in the opinion of the investigator, might put the subject at undue risk by study participation or interfere with the study conduct or evaluations

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Aclaris Therapeutics, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David Gordon, MD

Role: STUDY_DIRECTOR

Aclaris Therapeutics

Locations

Aclaris Investigational Site

Fort Washington, Pennsylvania, United States

Aclaris Investigational Site

Knoxville, Tennessee, United States

Aclaris Investigational Site

Austin, Texas, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

A-101-SEBK-402

Identifier Type: -

Identifier Source: org_study_id