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

NCT03487588 | Completed Phase 4 Results FDA Drug

• 1 other identifier: A-101-SEBK-402
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 3

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

Outcome Measures

Primary Outcomes (1)

• Subject Satisfaction

  Subject Satisfaction Questionnaire after treatment with A-101 Topical Solution

  Day 113

Secondary Outcomes (2)

• Effectiveness of Treatment

  Day 113

• Comparison of Physician Lesion Assessment Score (PLA) to Subject Satisfaction

  Day 113

Study Arms (1)

A-101 Topical Solution

EXPERIMENTAL

Open Label Arm

Drug: A-101 Topical Solution

Interventions

A-101 Topical Solution DRUG

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

A-101 Topical Solution

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject can comprehend and is willing to sign an informed consent for participation in this study.
• Male or female between the ages of 30 and 75 years old.
• 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.
• Subjects must have had cryosurgery for SK removal within the last 6 months and prior to first treatment with A-101 Topical Solution.
• Target and non-target SKs must not have been previously treated.
• 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

You may not qualify if:

• Subject has clinically atypical and /or rapidly growing Seborrheic Keratoses.
• Subject has current systemic malignancy.
• 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.
• 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

Sponsors & Collaborators

• Aclaris Therapeutics, Inc.: lead

Study Sites (3)

Aclaris Investigational Site

Fort Washington, Pennsylvania, 19034, United States

Location

Aclaris Investigational Site

Knoxville, Tennessee, 37922, United States

Location

Aclaris Investigational Site

Austin, Texas, 78759, United States

Location

MeSH Terms

Conditions

Keratosis, Seborrheic

Condition Hierarchy (Ancestors)

Keratosis; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Executive Director Clinical Operations
• Organization: Aclaris Therapeutics

jschnyder@aclaristx.com

4843247933

Study Officials

• David Gordon, MD

  Aclaris Therapeutics

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 2, 2018
• First Posted: April 4, 2018
• Study Start: March 21, 2018
• Primary Completion: November 14, 2018
• Study Completion: November 14, 2018
• Last Updated: October 2, 2019
• Results First Posted: October 2, 2019

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)