An A Study Assessing Subject Satisfaction With A-101 Topical Solution for Seborrheic Keratoses (SK-FAN)

An Open-Label Study Assessing Subject Satisfaction With A-101 Hydrogen Peroxide Topical Solution, 40% (w/w) Treatment for Seborrheic Keratoses of the Face, Neck, and Decolletage

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

Study Overview

• Status: Completed
• Conditions: Seborrheic Keratosis
• Intervention / Treatment: Drug: A-101 Topical Solution

• Study Type: Interventional
• Enrollment (Actual): 41
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Fort Washington, Pennsylvania, United States, 19034
      • Aclaris Investigational Site
  • Tennessee
    • Knoxville, Tennessee, United States, 37922
      • Aclaris Investigational Site
  • Texas
    • Austin, Texas, United States, 78759
      • Aclaris Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 28 years to 73 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: A-101 Topical Solution; Open Label Arm	Drug: A-101 Topical Solution; A-101 Topical Solution applied Day 1, Day 15 and Day 29

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subject Satisfaction	Subject Satisfaction Questionnaire after treatment with A-101 Topical Solution	Day 113

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effectiveness of Treatment	Effectiveness of treatment as measured by the Physician Lesion Assessment scale. The Physician Lesion Assessment Scale (PLA) is a 4 point scale used by the investigator to assess each subjects SK lesion. PLA=0 (Clear);PLA=1 (Near Clear; not elevated); PLA=2 (Thin;thickness </= 1 mm); PLA=3 (Thick; thickness > 1 mm).	Day 113
Comparison of Physician Lesion Assessment Score (PLA) to Subject Satisfaction	Effectiveness of treatment assessed by PLA (4-point scale) compared to subject reported satisfaction with treatment. The PLA scale is a 4 point scale used by the investigator to assess each subject's SK lesion.	Day 113

Collaborators and Investigators

• Sponsor: Aclaris Therapeutics, Inc.
• Investigators: Study Director: David Gordon, MD, Aclaris Therapeutics

Study record dates

Study Major Dates

• Study Start (Actual): March 21, 2018
• Primary Completion (Actual): November 14, 2018
• Study Completion (Actual): November 14, 2018

Study Registration Dates

• First Submitted: March 2, 2018
• First Submitted That Met QC Criteria: April 3, 2018
• First Posted (Actual): April 4, 2018

Study Record Updates

• Last Update Posted (Actual): October 2, 2019
• Last Update Submitted That Met QC Criteria: October 1, 2019
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Precancerous Conditions; Keratosis, Actinic; Keratosis; Keratosis, Seborrheic
• Other Study ID Numbers: A-101-SEBK-402

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No