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A Randomized, Vehicle-Controlled Study of 2 Concentrations 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 - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Subject is able to comprehend and is willing to sign an informed consent for participation in this study.
  2. Male or female ≥ 18 years old.
  3. Subject has a clinical diagnosis of stable clinically typical seborrheic keratosis.
  4. Subject has 4 appropriate seborrheic keratosis Target Lesions on the trunk, extremities and face, with at least 1 Target Lesion on the face and at least 1 Target Lesion on the trunk or extremities. The 4 identified Target Lesions must meet the requirements as defined below:

    1. Have a clinically typical appearance
    2. Have a Physician's Lesion Assessment of ≥ 2
    3. Length that is ≥ 5mm and ≤ 15mm
    4. Width that is ≥ 5mm and ≤ 15 mm
    5. Thickness that is ≤ 2mm
    6. Be a discrete lesion
    7. Be the only SK lesion present when centered in the area outlined by the provided circular template
    8. Not be covered with hair which, the in the investigator's opinion, would interfere with the study medication treatment or the study evaluations
    9. Not be in the intertriginous fold
    10. Not be on the eyelids
    11. Not be within 5mm of the orbital rim
    12. Not be pedunculated
  5. Subject chemistry and complete blood count results are within normal limits. If any of the laboratory values are outside normal range, the treating investigator must assess the value/s as NOT clinically significant and document this in the subject's medical chart in order for the subject to be eligible for randomization.
  6. Woman of childbearing potential must have a negative urine pregnancy test within 14 days of the first application of study drug and agree to use an active method of birth control for the duration of the study.
  7. Subject is non-pregnant and non-lactating.
  8. 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 Lesion or which exposes the subject to an unacceptable risk by study participation.
  9. Subject is willing and able to follow all study instructions and to attend all study visits.

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 current systemic malignancy.
  4. Subject has used any of the following systemic therapies within the specified period prior to Visit 1:

    • Retinoids; 180 days
    • Corticosteroids; 28 days
    • Anti-metabolites (e.g., methotrexate); 28 days
  5. Subject has used any of the following topical therapies within the specified period prior to Visit 1 on, or in a proximity to any Target Lesion, that in the investigator's opinion interferes with the study medication treatment or the study assessments:

    • LASER, light or other energy based therapy (e.g., intense pulsed light, photo-dynamic therapy; 180 days
    • Liquid nitrogen, electrodesiccation, curettage, imiquimod, 5-Fluorouracil, or ingenol mebutate; 60 days
    • Hydrogen peroxide: 90 days
    • Retinoids; 28 days
    • Microdermabrasion or superficial chemical peels; 14 days
    • Corticosteroids or antibiotics; 14 days
  6. Subject would require the use of any topical treatment (e.g. moisturizers, sunscreen) to any of the Target Lesions 12 hours prior to any study visit.
  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 any Target Lesion that, in the investigator's opinion, interferes with the study medication treatment or the study assessments:

    • Cutaneous malignancy; 180 days
    • Sunburn; currently
    • Pre-malignancy (e.g. actinic keratosis); currently
    • Body art (e.g. tattoos, piercing, etc.); currently
    • Excessive tan; currently. The use of self-tanning lotions/sprays are prohibited.
  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), 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.
  10. Participation in another therapeutic investigational drug trial in which administration of an investigational study medication occurred within 30 days prior to Visit 1.

Sites / Locations

  • Center for Dermatology and Dermatologic Surgery
  • Baumann Research Institute
  • MedaPhase, Inc
  • Union Square Laser Dermatology
  • Philadelphia Institute - Dermatology
  • Perelman Center for Advanced Medicine
  • Greenville Dermatology
  • The Skin Wellness Center, PC Clinical Research Division
  • DermResearch Inc

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Active Comparator

Active Comparator

Arm Label

Vehicle

A-101 Low Dose

A-101 High Dose

Arm Description

Vehicle Topical Solution

A-101 Low Dose Topical Solution

A-101 High DoseTopical Solution

Outcomes

Primary Outcome Measures

Mean of Per Subject Percentages of Target Lesions Judged to be Clear (PWA=0) at Visit 8
Mean of per subject percentages of target lesions judged to be clear (PWA=0) at Visit 8 Grade Descriptor 0 Clear: no visible seborrheic keratosis lesion Near Clear: a visible seborrheic keratosis lesion with a surface appearance different from the surrounding skin (not elevated) Thin: a visible seborrheic keratosis lesion (thickness ≤ 1 mm) Thick: a visible seborrheic keratosis lesion (thickness > 1 mm)

Secondary Outcome Measures

Full Information

First Posted
May 9, 2017
Last Updated
May 2, 2019
Sponsor
Aclaris Therapeutics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03148691
Brief Title
A Randomized, Vehicle-Controlled Study of 2 Concentrations of A-101 for the Treatment of Seborrheic Keratosis
Official Title
A Phase 2 Randomized, Double-Blind, Vehicle-Controlled, Parallel Group Study of the Safety and Effectiveness of A-101(Hydrogen Peroxide) Topical Solution in Subjects With Seborrheic Keratosis Lesions on the Trunk, Extremities, and Face
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
May 17, 2017 (Actual)
Primary Completion Date
February 28, 2018 (Actual)
Study Completion Date
April 3, 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
The primary objective of this study is to evaluate the safety and effectiveness of 2 concentrations of A-101 compared to Vehicle for the treatment of 4 seborrheic keratosis (SK) Target Lesions on the trunk, extremities and face.
Detailed Description
The primary objective of this study is to evaluate the safety and effectiveness of 2 concentrations of A-101 compared to Vehicle for the treatment of 4 seborrheic keratosis (SK) Target Lesions on the trunk, extremities and face. The secondary objectives of this study include duration of response of A-101. During the study, the investigator will identify 4 eligible SK Target Lesions on each subject on the trunk, extremities and face. For each subject, at least 1 SK Target Lesion must be on the face and at least 1 Target Lesion must be on the trunk or extremities. The Target Lesions will be treated at a maximum of two treatment visits.

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
253 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vehicle
Arm Type
Placebo Comparator
Arm Description
Vehicle Topical Solution
Arm Title
A-101 Low Dose
Arm Type
Active Comparator
Arm Description
A-101 Low Dose Topical Solution
Arm Title
A-101 High Dose
Arm Type
Active Comparator
Arm Description
A-101 High DoseTopical Solution
Intervention Type
Drug
Intervention Name(s)
A-101
Intervention Description
Topical Solution
Primary Outcome Measure Information:
Title
Mean of Per Subject Percentages of Target Lesions Judged to be Clear (PWA=0) at Visit 8
Description
Mean of per subject percentages of target lesions judged to be clear (PWA=0) at Visit 8 Grade Descriptor 0 Clear: no visible seborrheic keratosis lesion Near Clear: a visible seborrheic keratosis lesion with a surface appearance different from the surrounding skin (not elevated) Thin: a visible seborrheic keratosis lesion (thickness ≤ 1 mm) Thick: a visible seborrheic keratosis lesion (thickness > 1 mm)
Time Frame
Day 106

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subject is able to comprehend and is willing to sign an informed consent for participation in this study. Male or female ≥ 18 years old. Subject has a clinical diagnosis of stable clinically typical seborrheic keratosis. Subject has 4 appropriate seborrheic keratosis Target Lesions on the trunk, extremities and face, with at least 1 Target Lesion on the face and at least 1 Target Lesion on the trunk or extremities. The 4 identified Target Lesions must meet the requirements as defined below: Have a clinically typical appearance Have a Physician's Lesion Assessment of ≥ 2 Length that is ≥ 5mm and ≤ 15mm Width that is ≥ 5mm and ≤ 15 mm Thickness that is ≤ 2mm Be a discrete lesion Be the only SK lesion present when centered in the area outlined by the provided circular template Not be covered with hair which, the in the investigator's opinion, would interfere with the study medication treatment or the study evaluations Not be in the intertriginous fold Not be on the eyelids Not be within 5mm of the orbital rim Not be pedunculated Subject chemistry and complete blood count results are within normal limits. If any of the laboratory values are outside normal range, the treating investigator must assess the value/s as NOT clinically significant and document this in the subject's medical chart in order for the subject to be eligible for randomization. Woman of childbearing potential must have a negative urine pregnancy test within 14 days of the first application of study drug and agree to use an active method of birth control 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 the evaluation of any 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. 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 current systemic malignancy. Subject has used any of the following systemic therapies within the specified period prior to Visit 1: Retinoids; 180 days Corticosteroids; 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 any Target Lesion, that in the investigator's opinion interferes with the study medication treatment or the study assessments: LASER, light or other energy based therapy (e.g., intense pulsed light, photo-dynamic therapy; 180 days Liquid nitrogen, electrodesiccation, curettage, imiquimod, 5-Fluorouracil, or ingenol mebutate; 60 days Hydrogen peroxide: 90 days Retinoids; 28 days Microdermabrasion or superficial chemical peels; 14 days Corticosteroids or antibiotics; 14 days Subject would require the use of any topical treatment (e.g. moisturizers, sunscreen) to any of the Target Lesions 12 hours prior to any study visit. Subject currently has or has had any of the following within the specified period prior to Visit 1 on or in a proximity to any Target Lesion that, in the investigator's opinion, interferes with the study medication treatment or the study assessments: Cutaneous malignancy; 180 days Sunburn; currently Pre-malignancy (e.g. actinic keratosis); currently Body art (e.g. tattoos, piercing, etc.); currently Excessive tan; currently. The use of self-tanning lotions/sprays are prohibited. 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), 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. Participation in another therapeutic 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
Stuart D Shanler, MD
Organizational Affiliation
Aclaris Therapeutics, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Center for Dermatology and Dermatologic Surgery
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20037
Country
United States
Facility Name
Baumann Research Institute
City
Miami
State/Province
Florida
ZIP/Postal Code
33137
Country
United States
Facility Name
MedaPhase, Inc
City
Newnan
State/Province
Georgia
ZIP/Postal Code
30263
Country
United States
Facility Name
Union Square Laser Dermatology
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
Facility Name
Philadelphia Institute - Dermatology
City
Fort Washington
State/Province
Pennsylvania
ZIP/Postal Code
19034
Country
United States
Facility Name
Perelman Center for Advanced Medicine
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Greenville Dermatology
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29607
Country
United States
Facility Name
The Skin Wellness Center, PC Clinical Research Division
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37922
Country
United States
Facility Name
DermResearch Inc
City
Austin
State/Province
Texas
ZIP/Postal Code
78759
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

A Randomized, Vehicle-Controlled Study of 2 Concentrations of A-101 for the Treatment of Seborrheic Keratosis

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