Study of A-101 for the Treatment of Seborrheic Keratosis

• ClinicalTrials.gov Identifier: NCT02260180
• Recruitment Status: Completed
• First Posted: October 9, 2014
• Results First Posted: December 6, 2018
• Last Update Posted: December 2, 2020
• Sponsor: Aclaris Therapeutics, Inc.
• Information provided by (Responsible Party): Aclaris Therapeutics, Inc.

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.

Condition or disease	Intervention/treatment	Phase
Seborrheic Keratosis	Drug: A-101	Phase 2

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 119 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• 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 Start Date: October 2014
• Actual Primary Completion Date: March 2015
• Actual Study Completion Date: March 2015

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: A-101 40%; A-101 40% Topical Solution	Drug: A-101; Topical Solution
Active Comparator: A-101 32.5%; A-101 32.5% Topical Solution	Drug: A-101; Topical Solution
Placebo Comparator: A-101 Vehicle Topical Solution; A-101 0% Topical Solution (vehicle)	Drug: A-101; Topical Solution

Outcome Measures

Primary Outcome Measures :

1. Percentage of PLA Responders With Target Lesion Clear (PLA = 0) in Each Arm at Visit 8. [ Time Frame: Day 106 ]
   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 :

1. Mean Change From Baseline PLA Score at Visit 8 [ Time Frame: Day 106 ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 75 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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.

Contacts and Locations

Locations

United States, Oregon

Oregon Medical Research Center

Portland, Oregon, United States, 97223

United States, Pennsylvania

Philadelphia Institute of Dermatology

Fort Washington, Pennsylvania, United States, 19034

United States, Texas

DermReseach, Inc.

Austin, Texas, United States, 78759

United States, Virginia

The Education & Research Foundation, Inc.

Lynchburg, Virginia, United States, 24501

Sponsors and Collaborators

Aclaris Therapeutics, Inc.

Investigators

• Study Director: Brian Beger, BS; Aclaris Therapeutics, Inc.

  Study Documents (Full-Text)

Documents provided by Aclaris Therapeutics, Inc.:

Study Protocol and Statistical Analysis Plan  [PDF] July 1, 2014

More Information

• Responsible Party: Aclaris Therapeutics, Inc.
• ClinicalTrials.gov Identifier: NCT02260180
• Other Study ID Numbers: A-101-SEBK-203
• First Posted: October 9, 2014
• Results First Posted: December 6, 2018
• Last Update Posted: December 2, 2020
• Last Verified: November 2020

Additional relevant MeSH terms:

Keratosis, Actinic; Keratosis; Keratosis, Seborrheic; Skin Diseases; Precancerous Conditions; Neoplasms