ClinicalTrials.gov
ClinicalTrials.gov Menu

A Study of A-101 Solution 40% in Subjects With Seborrheic Keratosis.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02667236
Recruitment Status : Completed
First Posted : January 28, 2016
Results First Posted : November 13, 2017
Last Update Posted : February 6, 2018
Sponsor:
Information provided by (Responsible Party):
Aclaris Therapeutics, Inc.

Brief Summary:
This is a randomized, double-blind, vehicle-controlled, parallel group study of A-101 Solution 40% compared with Vehicle Solution.

Condition or disease Intervention/treatment Phase
Seborrheic Keratosis Drug: A-101 Solution Other: Vehicle Solution Phase 3

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. The Target Lesions will be treated, by an investigational staff member other than the evaluating investigator, a maximum of two times.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 450 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 Safety and Effectiveness of A-101 Solution 40% in Subjects With Seborrheic Keratosis on the Trunk, Extremities and Face.
Study Start Date : January 2016
Actual Primary Completion Date : October 2016
Actual Study Completion Date : October 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: A-101 Solution
A-101 Solution 40% administered once
Drug: A-101 Solution
Active Drug

Placebo Comparator: Vehicle Solution
Vehicle Solution administered once
Other: Vehicle Solution
Placebo




Primary Outcome Measures :
  1. Proportion of Subjects With Target Lesion Clearance as Assessed by the Physician Lesion Assessment [ Time Frame: Day 106 of the study ]
    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 PLA Scale is a 4 point scale used by the investigator to assess each subject's target SK Lesion.


Secondary Outcome Measures :
  1. Proportion of Subjects With 3 of 4 Target Lesion Clearance [ Time Frame: Day 106 of the study ]
    Proportion of Subjects for whom at least 3 of 4 target lesions were judged to be clear on the Physician Lesion Assessment (PLA=0) at Visit 8



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (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. 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02667236


Locations
United States, Pennsylvania
Aclaris Therapeutics, Inc.
Malvern, Pennsylvania, United States, 19355
Sponsors and Collaborators
Aclaris Therapeutics, Inc.
Investigators
Study Director: Stuart D Shanler, MD Chief SCience Officer

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Aclaris Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT02667236     History of Changes
Other Study ID Numbers: A-101-SEBK-301
First Posted: January 28, 2016    Key Record Dates
Results First Posted: November 13, 2017
Last Update Posted: February 6, 2018
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Aclaris Therapeutics, Inc.:
seborrheic keratosis

Additional relevant MeSH terms:
Keratosis
Keratosis, Actinic
Keratosis, Seborrheic
Skin Diseases
Precancerous Conditions
Neoplasms
Pharmaceutical Solutions