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

Primary Purpose

Seborrheic Keratosis

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
A-101 Topical Solution
Sponsored by
Aclaris Therapeutics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Seborrheic Keratosis

Eligibility Criteria

30 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Aclaris Investigational Site
  • Aclaris Investigational Site
  • Aclaris Investigational Site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

A-101 Topical Solution

Arm Description

Open Label Arm

Outcomes

Primary Outcome Measures

Subject Satisfaction
Subject Satisfaction Questionnaire after treatment with A-101 Topical Solution

Secondary Outcome Measures

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).
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.

Full Information

First Posted
March 2, 2018
Last Updated
October 1, 2019
Sponsor
Aclaris Therapeutics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03487588
Brief Title
An A Study Assessing Subject Satisfaction With A-101 Topical Solution for Seborrheic Keratoses
Acronym
SK-FAN
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
March 21, 2018 (Actual)
Primary Completion Date
November 14, 2018 (Actual)
Study Completion Date
November 14, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Aclaris Therapeutics, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Seborrheic Keratosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
41 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A-101 Topical Solution
Arm Type
Experimental
Arm Description
Open Label Arm
Intervention Type
Drug
Intervention Name(s)
A-101 Topical Solution
Intervention Description
A-101 Topical Solution applied Day 1, Day 15 and Day 29
Primary Outcome Measure Information:
Title
Subject Satisfaction
Description
Subject Satisfaction Questionnaire after treatment with A-101 Topical Solution
Time Frame
Day 113
Secondary Outcome Measure Information:
Title
Effectiveness of Treatment
Description
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).
Time Frame
Day 113
Title
Comparison of Physician Lesion Assessment Score (PLA) to Subject Satisfaction
Description
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.
Time Frame
Day 113

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Gordon, MD
Organizational Affiliation
Aclaris Therapeutics
Official's Role
Study Director
Facility Information:
Facility Name
Aclaris Investigational Site
City
Fort Washington
State/Province
Pennsylvania
ZIP/Postal Code
19034
Country
United States
Facility Name
Aclaris Investigational Site
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37922
Country
United States
Facility Name
Aclaris Investigational Site
City
Austin
State/Province
Texas
ZIP/Postal Code
78759
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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