NCT02160626

Brief Summary

The main objective of this study is to evaluate the dose-response relationship of two concentrations of A-101 solution when applied to individual seborrheic keratosis (SK) lesions (target lesions) compared with a matching A-101 Solution Vehicle.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
172

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jun 2014

Shorter than P25 for phase_2

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2014

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

June 6, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 11, 2014

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
4 years until next milestone

Results Posted

Study results publicly available

December 7, 2018

Completed
Last Updated

January 3, 2019

Status Verified

December 1, 2018

Enrollment Period

6 months

First QC Date

June 6, 2014

Results QC Date

September 30, 2018

Last Update Submit

December 10, 2018

Conditions

Seborrheic Keratosis

Keywords

Seborrheic keratosisA101

Outcome Measures

Primary Outcomes (1)

  • Mean Per Subject Percentage Target Lesions Judged Clear by the Physician's Lesion Assessment (PLA)

    Mean of per-subject percentages of target lesions judged to be clear on the PLA (PLA = 0) at end of study (Visit 8). The PLA is a four point scale from 0 being clear to 3 being most severe lesion.

    Baseline, visit 8

Secondary Outcomes (2)

  • Mean Change From Baseline to Visit 8 in the Physician's Lesion Assessment

    Baseline, visit 8

  • Proportion of Subjects Who Had at Least 3 of 4 Target Lesions Judged to be Clear on the Physician Lesion Assessment (PLA =0) at Visit 8.

    Baseline, visit 8

Study Arms (3)

A-101 Vehicle

PLACEBO COMPARATOR

A-101 Vehicle (placebo) Topical Solution

Drug: A-101 Vehicle

A-101 (40) Topical Solution

ACTIVE COMPARATOR

A-101 (40) Topical Solution - high dose

Drug: A-101 (40) Topical Solution

A-101 (32.5) Topical Solution

ACTIVE COMPARATOR

A-101 (32.5) Topical Solution - low dose

Drug: A-101 (32.5) Topical Solution

Interventions

A-101 VehicleDRUG

Placebo control

A-101 Vehicle
A-101 (40) Topical SolutionDRUG

A-101 (40) Topical Solution - high dose

A-101 (40) Topical Solution
A-101 (32.5) Topical SolutionDRUG

A-101 (32.5) Topical Solution - low dose

A-101 (32.5) Topical Solution

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subject is at least 18 years of age
  • Subject has a clinical diagnosis of stable clinically typical seborrheic keratosis
  • Subject has 4 appropriate seborrheic keratosis target lesions, as defined below, on the trunk/extremities:
  • Have a clinically typical appearance
  • Be treatment naïve
  • Have a Physician Lesion Assessment (PLA) of ≥2
  • Have a longest axis that is ≥7mm and ≤15mm
  • Have a longest dimension perpendicular to the longest axis that is ≥7mm and ≤15mm
  • 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 in an intertriginous fold
  • Not be in an area where clothing, such as a bra, might cause physical irritation
  • Not be pedunculated.
  • If the subject is a woman of childbearing potential, she has a negative urine pregnancy test and agrees to use an active form of birth control for the duration of the study
  • +4 more criteria

You may not qualify if:

  • 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
  • Glucocorticosteroids; 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, that 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; 90 days
  • Liquid nitrogen, electrodesiccation, curettage, imiquimod, 5-fluorouracil, or ingenol mebutate; 60 days
  • Glucocorticosteroids or antibiotics; 14 days
  • Moisturizers/emollients, sunscreens; 12 hours
  • 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 that, in the investigator's opinion, interferes with the application of the study medication or the study assessments:
  • +8 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Gwinnett Clinical Research Center, Inc.

Snellville, Georgia, 30078, United States

Location

Michigan Center for Research Corp.

Clinton Township, Michigan, 48038, United States

Location

Oregon Medical Research Center

Portland, Oregon, 97223, United States

Location

DermReseach, Inc.

Austin, Texas, 78759, United States

Location

The Education & Research Foundation, Inc.

Lynchburg, Virginia, 24501, United States

Location

MeSH Terms

Conditions

Keratosis, Seborrheic

Interventions

N-phenylacetoaminomethylene-DL-p-nitrophenylalanineSolutions

Condition Hierarchy (Ancestors)

KeratosisSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Pharmaceutical Preparations

Results Point of Contact

Title
Judith Schnyder
Organization
Aclaris Therapeutics Inc.
jschnyder@aclaristx.com
+1-484-329-2144

Study Officials

  • Jonathan S Weiss, MD

    Gwinnett Clinical Research Center, Inc.

    PRINCIPAL INVESTIGATOR

  • Janet Dubois, MD

    Derm Research, PLLC

    PRINCIPAL INVESTIGATOR

  • David C Wilson, MD

    The Education & Research Foundation, Inc.

    PRINCIPAL INVESTIGATOR

  • Daniel M Stewart, DO

    Michigan Center for Research Corp.

    PRINCIPAL INVESTIGATOR

  • Andrew Blauvelt, MD, MBA

    Oregon Medical Research Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 6, 2014

First Posted

June 11, 2014

Study Start

June 1, 2014

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

January 3, 2019

Results First Posted

December 7, 2018

Record last verified: 2018-12

Locations

US(5)