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

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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.

Tracking Information
First Submitted Date  ICMJE January 26, 2016
First Posted Date  ICMJE January 28, 2016
Results First Submitted Date  ICMJE October 13, 2017
Results First Posted Date  ICMJE November 13, 2017
Last Update Posted Date February 6, 2018
Study Start Date  ICMJE January 2016
Actual Primary Completion Date October 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 11, 2018)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: January 26, 2016)
Lesion Clearance [ Time Frame: Day 106 of the study ]
Change History Complete list of historical versions of study NCT02667236 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 11, 2018)
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
Original Secondary Outcome Measures  ICMJE
 (submitted: January 26, 2016)
Percent of Lesion Clearance [ Time Frame: Day 106 of the study ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of A-101 Solution 40% in Subjects With Seborrheic Keratosis.
Official Title  ICMJE 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.
Brief Summary This is a randomized, double-blind, vehicle-controlled, parallel group study of A-101 Solution 40% compared with Vehicle 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. The Target Lesions will be treated, by an investigational staff member other than the evaluating investigator, a maximum of two times.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Seborrheic Keratosis
Intervention  ICMJE
  • Drug: A-101 Solution
    Active Drug
  • Other: Vehicle Solution
    Placebo
Study Arms  ICMJE
  • Active Comparator: A-101 Solution
    A-101 Solution 40% administered once
    Intervention: Drug: A-101 Solution
  • Placebo Comparator: Vehicle Solution
    Vehicle Solution administered once
    Intervention: Other: Vehicle Solution
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 1, 2016)
450
Original Estimated Enrollment  ICMJE
 (submitted: January 26, 2016)
400
Actual Study Completion Date  ICMJE October 2016
Actual Primary Completion Date October 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02667236
Other Study ID Numbers  ICMJE A-101-SEBK-301
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Aclaris Therapeutics, Inc.
Study Sponsor  ICMJE Aclaris Therapeutics, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Stuart D Shanler, MD Chief SCience Officer
PRS Account Aclaris Therapeutics, Inc.
Verification Date December 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP