A Randomized, Double-Blind, Vehicle-Controlled Study in Subjects With Seborrheic Keratosis (SK)

A Randomized, Double-Blind, Vehicle-Controlled, PArallel Group Study of the Safety and Effectiveness of A-101 Solution 40% in Subjects With Seborrheic Keratosis on the Trunk, Extremities and Face.

This is a randomized, double-blind, vehicle-controlled, parallel group study.

Study Overview

• Status: Completed
• Conditions: Seborrheic Keratosis
• Intervention / Treatment: Other: Vehicle Solution; Drug: A-101 Solution

Detailed Description

This is a randomized, double-blind, vehicle-controlled, parallel group study. During this study, the investigator will identify 4 eligible SK Target Lesions on each subject on the trunk, extremities and face.

• Study Type: Interventional
• Enrollment (Actual): 487
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Malvern, Pennsylvania, United States, 19355
      • Aclaris Therapeutics, 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 at least 18 years of age
2. Clinical diagnosis of stable clinically typical seborrheic keratosis

3. Subject has 4 appropriate seborrheic keratosis Target Lesions on the trunk, extremities and face that each are eligible for treatment as defined below:

   • Have a clinically typical appearance
   • Have a PLA of 2 or greater and be a discrete lesion
   • Not be covered with hair which, in the investigator's opinion, would interfere with the study medication treatment or the study evaluations
   • Not be in an intertriginous fold
   • Not be on the eyelids
   • Not be within 5mm of the orbital rim
   • Not be pedunculated
4. If the subject is a woman of childbearing potential, she has a negative urine pregnancy test and agrees to use an active method of birth control for the duration of the study
5. Subject is non-pregnant and non-lactating
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 evaluation of any Target Lesion or which exposes the subject to an unacceptable risk by study participation
7. Subject is willing and able to follow all study instructions and to attend all study visits
8. Subject is able to comprehend and willing to sign an Informed Consent Form.

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 Lesser -Trelat) 3. Subject has a current systemic malignancy 4. Subject has used any of the following systemic therapies within the specified period prior to enrollment:

• Retinoids; 180 days
• Glucocortico-steroids;
• Anti-metabolites (e.g., methotrexate); 5. Subject has used any of the following topical therapies within the specified period 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;
• Liquid nitrogen, electrodesiccation, curettage, imiquimod, 5-flurouracil, or ingenol mebutate;
• Retinoids;
• Microdermabrasion or superficial chemical peels;
• Glucocortico-steroids or antibiotics 6. Subject currently has or has had any of the following within the specified period or in a proximity to any Target Lesion that, in the investigator's opinion, interferes with the study medication treatment or the study assessments:
• A cutaneous malignancy;
• A sunburn; currently
• A pre-malignancy (e.g., actinic keratosis); currently
• Body art (e.g., tattoos, piercing, etc.); currently
• Excessive tan; currently 7. Subject has a history of sensitivity to any of the ingredients in the study medications 8. Subject has any current skin disease (e.g., psoriasis, atopic dermatitis, eczema, sun damage, etc.), 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 9. Subject has participated in an investigational drug trial in which administration of an investigational study medication occurred within 30 days prior to enrollment.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Vehicle Solution; Vehicle Solution administered once	Other: Vehicle Solution; Placebo
Experimental: A-101 Solution; A-101 Solution 40% administered once	Drug: A-101 Solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of Subjects With All Target Lesions Cleared According to Physician Lesion Assessment Scale	Proportion of subjects for whom all target lesions were judged to be clear on the Physician Lesion Assessment Scale (PLA=0) at Visit 8. The Physician Lesion Assessment Scale is a 4 point scale used by the investigator to assess the subject's target sk lesions.	Study day 106

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent of Lesions Cleared Scale	Proportion of Subjects for whom at least 3 of 4 target lesions were judged to be clear on the Physician Lesion Assessment Scale (PLA=0) at Visit 8	Study day 106

Collaborators and Investigators

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

Publications and helpful links

General Publications

• Smith SR, Xu S, Estes E, Shanler SD. Anatomic Site-Specific Treatment Response With 40% Hydrogen Peroxide (w/w) Topical Formulation for Raised Seborrheic Keratoses: Pooled Analysis of Data from Two Phase 3 Studies. J Drugs Dermatol. 2018 Oct 1;17(10):1092-1098.

Study record dates

Study Major Dates

• Study Start: January 1, 2016
• Primary Completion (Actual): October 1, 2016
• Study Completion (Actual): October 1, 2016

Study Registration Dates

• First Submitted: January 26, 2016
• First Submitted That Met QC Criteria: January 27, 2016
• First Posted (Estimate): January 28, 2016

Study Record Updates

• Last Update Posted (Actual): February 6, 2018
• Last Update Submitted That Met QC Criteria: January 11, 2018
• Last Verified: January 1, 2016

More Information

Terms related to this study

• Keywords: seborrheic keratosis
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Precancerous Conditions; Keratosis, Actinic; Keratosis; Keratosis, Seborrheic; Pharmaceutical Solutions
• Other Study ID Numbers: A-101-SEBK-302

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided