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

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

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.

Study Overview

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

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.

• Study Type: Interventional
• Enrollment (Actual): 253
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • District of Columbia
    • Washington, District of Columbia, United States, 20037
      • Center for Dermatology and Dermatologic Surgery
  • Florida
    • Miami, Florida, United States, 33137
      • Baumann Research Institute
  • Georgia
    • Newnan, Georgia, United States, 30263
      • MedaPhase, Inc
  • New York
    • New York, New York, United States, 10003
      • Union Square Laser Dermatology
  • Pennsylvania
    • Fort Washington, Pennsylvania, United States, 19034
      • Philadelphia Institute - Dermatology
    • Philadelphia, Pennsylvania, United States, 19104
      • Perelman Center for Advanced Medicine
  • South Carolina
    • Greenville, South Carolina, United States, 29607
      • Greenville Dermatology
  • Tennessee
    • Knoxville, Tennessee, United States, 37922
      • The Skin Wellness Center, PC Clinical Research Division
  • Texas
    • Austin, Texas, United States, 78759
      • DermResearch Inc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Vehicle; Vehicle Topical Solution	Drug: A-101; Topical Solution
Active Comparator: A-101 Low Dose; A-101 Low Dose Topical Solution	Drug: A-101; Topical Solution
Active Comparator: A-101 High Dose; A-101 High DoseTopical Solution	Drug: A-101; Topical Solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	Day 106

Collaborators and Investigators

• Sponsor: Aclaris Therapeutics, Inc.
• Investigators: Study Director: Stuart D Shanler, MD, Aclaris Therapeutics, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): May 17, 2017
• Primary Completion (Actual): February 28, 2018
• Study Completion (Actual): April 3, 2018

Study Registration Dates

• First Submitted: May 9, 2017
• First Submitted That Met QC Criteria: May 9, 2017
• First Posted (Actual): May 11, 2017

Study Record Updates

• Last Update Posted (Actual): May 6, 2019
• Last Update Submitted That Met QC Criteria: May 2, 2019
• Last Verified: May 1, 2019

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-204

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
• product manufactured in and exported from the U.S.: No