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Study of A-101 for the Treatment of Seborrheic Keratosis

Primary Purpose

Seborrheic Keratosis

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
A-101
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

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

Inclusion Criteria:

  1. Subject is at least 18 years of age
  2. Subject has a Fitzpatrick skin type of 1-4
  3. Subject has a clinical diagnosis of stable clinically typical seborrheic keratosis
  4. Subject has 1 appropriate seborrheic keratosis target lesion, as defined below (Section 5.4), on the face:

    • Have a clinically typical appearance
    • Be treatment naïve
    • Have a Physician's Lesion Assessment (PLA) of ≥2 (Section 6.1.2)
    • Have a longest axis that is ≥7mm and ≤15mm (Section 5.4)
    • Have a longest dimension perpendicular to the longest axis that is ≥7mm and ≤15mm (Section 5.4)
    • Have a thickness that is ≤2mm
    • Be a discrete lesion
    • Be, when centered in the area outlined by the provided 3cm diameter circular template, the only seborrheic keratosis lesion present
    • Not be on the eyelids
    • Not be within 5mm of the orbital rim
    • Not be covered with hair which, in the investigator's opinion, would interfere with the study medication application or the study evaluations (NB: the study medication may bleach hair)
    • Not be in an intertriginous fold
    • Not be pedunculated.
  5. If the subject is a woman of childbearing potential, she has a negative urine pregnancy test and agrees to use an approved effective method of birth control (Section 8) for the duration of the study
  6. Subject is non-pregnant and non-lactating
  7. Subject is in good general health and free of any known disease state or physical condition which, in the investigator's opinion, might impair evaluation of the target lesion or which exposes the subject to an unacceptable risk by study participation
  8. Subject is willing and able to follow all study instructions and to attend all study visits
  9. Subject is able to comprehend and willing to sign an Informed Consent Form (ICF).

Exclusion Criteria:

  1. Subject has clinically atypical and/or rapidly growing seborrheic keratosis lesions
  2. Subject has presence of multiple eruptive seborrheic keratosis lesions (Sign of Leser-Trelat)
  3. Subject has a current systemic malignancy
  4. Subject has a history of keloid formation or hypertrophic scarring
  5. Subject has used any of the following systemic therapies within the specified period prior to Visit 1:

    • Retinoids; 180 days
    • Glucocortico-steroids; 28 days
    • Anti-metabolites (e.g., methotrexate); 28 days
  6. Subject has used any of the following topical therapies within the specified period prior to Visit 1 on, or in a proximity to the target lesion, which in the investigator's opinion, interferes with the application of the study medication or the study assessments:

    • LASER, light (e.g., intense pulsed light (IPL), photo-dynamic therapy(PDT)) or other energy based therapy; 180 days
    • Retinoids; 28 days
    • Liquid nitrogen, electrodesiccation, curettage, imiquimod, 5-fluorouracil, or ingenol mebutate; 60 days
    • Glucocortico-steroids or antibiotics; 14 days
  7. Subject currently has or has had any of the following within the specified period prior to Visit 1 on, or in a proximity to the target lesion, which in the investigator's opinion, interferes with the application of the study medication or the study assessments :

    • A cutaneous malignancy; 180 days
    • Experienced a sunburn; 28 days
    • A pre-malignancy (e.g., actinic keratosis); currently
    • Body art (e.g., tattoos, piercing, etc.); currently
    • Excessive tan; currently
  8. Subject has a history of sensitivity to any of the ingredients in the study medications
  9. Subject has any current skin disease (e.g., psoriasis, atopic dermatitis, eczema, sun damage, etc.), or condition (e.g., sunburn, excessive hair, open wounds) which, in the investigator's opinion, might put the subject at undue risk by study participation or interfere with the study conduct or evaluations
  10. Subject has participated in an investigational drug trial in which administration of an investigational study medication occurred within 30 days prior to Visit 1.

Sites / Locations

  • Oregon Medical Research Center
  • Philadelphia Institute of Dermatology
  • DermReseach, Inc.
  • The Education & Research Foundation, Inc.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

A-101 40%

A-101 32.5%

A-101 Vehicle Topical Solution

Arm Description

A-101 40% Topical Solution

A-101 32.5% Topical Solution

A-101 0% Topical Solution (vehicle)

Outcomes

Primary Outcome Measures

Percentage of PLA Responders With Target Lesion Clear (PLA = 0) in Each Arm at Visit 8.
The primary effectiveness analysis was a comparison between each A-101 group and the vehicle group based on the percentage with target lesions judged to be clear on the PLA (PLA = 0) at Visit 8. The three arms of the study are A-101 40% Topical Solution, A-101 32.5% Topical Solution, and A-101 0% Topical Solution (vehicle). The Physician's Lesion Analysis ( PLA) is a 4 point scale from 0 to 3, with 0 being lesion clear and 3 being the most severe lesion. A larger proportion of subjects with a PLA =0 is better.

Secondary Outcome Measures

Mean Change From Baseline PLA Score at Visit 8
A secondary efficacy analysis was the mean change from baseline PLA Score at visit 8. The three arms of the study are A-101 40% Topical Solution, A-101 32.5% Topical Solution, and A-101 0% Topical Solution (vehicle). The Physician's Lesion Analysis ( PLA) is a 4 point scale from 0 to 3, with 0 being lesion clear and 3 being the most severe lesion. A larger proportion of subjects with a PLA =0 is better. A lower (more negative) mean change is a better outcome.

Full Information

First Posted
October 3, 2014
Last Updated
November 17, 2020
Sponsor
Aclaris Therapeutics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02260180
Brief Title
Study of A-101 for the Treatment of Seborrheic Keratosis
Official Title
A Randomized, Double-Blind, Vehicle-Controlled, Parallel Group Study of the Dose-Response Profile of A-101 Topical Solution in Subjects With Seborrheic Keratosis of the Face
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
October 2014 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
March 2015 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to evaluate the safety and dose-response of 2 concentrations of A-101 versus a vehicle control in the treatment of seborrheic keratosis.
Detailed Description
The main objective of this study is to evaluate the dose-response relationship of 2 concentrations of A-101 Solution and its matching A-101 Solution Vehicle when applied to seborrheic Keratosis (SK) target lesions on the face. A further objective is to evaluate the safety and efficacy of 2 concentrations of A-101 Solution and its matching A-101 Solution Vehicle when applied topically up to 2 times to SK target lesions on the face.

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 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
119 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A-101 40%
Arm Type
Active Comparator
Arm Description
A-101 40% Topical Solution
Arm Title
A-101 32.5%
Arm Type
Active Comparator
Arm Description
A-101 32.5% Topical Solution
Arm Title
A-101 Vehicle Topical Solution
Arm Type
Placebo Comparator
Arm Description
A-101 0% Topical Solution (vehicle)
Intervention Type
Drug
Intervention Name(s)
A-101
Intervention Description
Topical Solution
Primary Outcome Measure Information:
Title
Percentage of PLA Responders With Target Lesion Clear (PLA = 0) in Each Arm at Visit 8.
Description
The primary effectiveness analysis was a comparison between each A-101 group and the vehicle group based on the percentage with target lesions judged to be clear on the PLA (PLA = 0) at Visit 8. The three arms of the study are A-101 40% Topical Solution, A-101 32.5% Topical Solution, and A-101 0% Topical Solution (vehicle). The Physician's Lesion Analysis ( PLA) is a 4 point scale from 0 to 3, with 0 being lesion clear and 3 being the most severe lesion. A larger proportion of subjects with a PLA =0 is better.
Time Frame
Day 106
Secondary Outcome Measure Information:
Title
Mean Change From Baseline PLA Score at Visit 8
Description
A secondary efficacy analysis was the mean change from baseline PLA Score at visit 8. The three arms of the study are A-101 40% Topical Solution, A-101 32.5% Topical Solution, and A-101 0% Topical Solution (vehicle). The Physician's Lesion Analysis ( PLA) is a 4 point scale from 0 to 3, with 0 being lesion clear and 3 being the most severe lesion. A larger proportion of subjects with a PLA =0 is better. A lower (more negative) mean change is a better outcome.
Time Frame
Day 106

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subject is at least 18 years of age Subject has a Fitzpatrick skin type of 1-4 Subject has a clinical diagnosis of stable clinically typical seborrheic keratosis Subject has 1 appropriate seborrheic keratosis target lesion, as defined below (Section 5.4), on the face: Have a clinically typical appearance Be treatment naïve Have a Physician's Lesion Assessment (PLA) of ≥2 (Section 6.1.2) Have a longest axis that is ≥7mm and ≤15mm (Section 5.4) Have a longest dimension perpendicular to the longest axis that is ≥7mm and ≤15mm (Section 5.4) Have a thickness that is ≤2mm Be a discrete lesion Be, when centered in the area outlined by the provided 3cm diameter circular template, the only seborrheic keratosis lesion present Not be on the eyelids Not be within 5mm of the orbital rim Not be covered with hair which, in the investigator's opinion, would interfere with the study medication application or the study evaluations (NB: the study medication may bleach hair) Not be in an intertriginous fold Not be pedunculated. If the subject is a woman of childbearing potential, she has a negative urine pregnancy test and agrees to use an approved effective method of birth control (Section 8) for the duration of the study Subject is non-pregnant and non-lactating Subject is in good general health and free of any known disease state or physical condition which, in the investigator's opinion, might impair evaluation of the target lesion or which exposes the subject to an unacceptable risk by study participation Subject is willing and able to follow all study instructions and to attend all study visits Subject is able to comprehend and willing to sign an Informed Consent Form (ICF). Exclusion Criteria: Subject has clinically atypical and/or rapidly growing seborrheic keratosis lesions Subject has presence of multiple eruptive seborrheic keratosis lesions (Sign of Leser-Trelat) Subject has a current systemic malignancy Subject has a history of keloid formation or hypertrophic scarring Subject has used any of the following systemic therapies within the specified period prior to Visit 1: Retinoids; 180 days Glucocortico-steroids; 28 days Anti-metabolites (e.g., methotrexate); 28 days Subject has used any of the following topical therapies within the specified period prior to Visit 1 on, or in a proximity to the target lesion, which in the investigator's opinion, interferes with the application of the study medication or the study assessments: LASER, light (e.g., intense pulsed light (IPL), photo-dynamic therapy(PDT)) or other energy based therapy; 180 days Retinoids; 28 days Liquid nitrogen, electrodesiccation, curettage, imiquimod, 5-fluorouracil, or ingenol mebutate; 60 days Glucocortico-steroids or antibiotics; 14 days Subject currently has or has had any of the following within the specified period prior to Visit 1 on, or in a proximity to the target lesion, which in the investigator's opinion, interferes with the application of the study medication or the study assessments : A cutaneous malignancy; 180 days Experienced a sunburn; 28 days A pre-malignancy (e.g., actinic keratosis); currently Body art (e.g., tattoos, piercing, etc.); currently Excessive tan; currently Subject has a history of sensitivity to any of the ingredients in the study medications Subject has any current skin disease (e.g., psoriasis, atopic dermatitis, eczema, sun damage, etc.), or condition (e.g., sunburn, excessive hair, open wounds) which, in the investigator's opinion, might put the subject at undue risk by study participation or interfere with the study conduct or evaluations Subject has participated in an investigational drug trial in which administration of an investigational study medication occurred within 30 days prior to Visit 1.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brian Beger, BS
Organizational Affiliation
Aclaris Therapeutics, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Oregon Medical Research Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97223
Country
United States
Facility Name
Philadelphia Institute of Dermatology
City
Fort Washington
State/Province
Pennsylvania
ZIP/Postal Code
19034
Country
United States
Facility Name
DermReseach, Inc.
City
Austin
State/Province
Texas
ZIP/Postal Code
78759
Country
United States
Facility Name
The Education & Research Foundation, Inc.
City
Lynchburg
State/Province
Virginia
ZIP/Postal Code
24501
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Study of A-101 for the Treatment of Seborrheic Keratosis

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