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An A Study Assessing Subject Satisfaction With A-101 Topical Solution for Seborrheic Keratoses (SK-FAN)

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. Identifier: NCT03487588
Recruitment Status : Completed
First Posted : April 4, 2018
Results First Posted : October 2, 2019
Last Update Posted : October 2, 2019
Information provided by (Responsible Party):
Aclaris Therapeutics, Inc.

Brief Summary:
This study is an open-label study designed to evaluate subject's satisfaction after treatment of seborrheic keratoses with A-101 40%.

Condition or disease Intervention/treatment Phase
Seborrheic Keratosis Drug: A-101 Topical Solution Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 41 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label Study Assessing Subject Satisfaction With A-101 Hydrogen Peroxide Topical Solution, 40% (w/w) Treatment for Seborrheic Keratoses of the Face, Neck, and Decolletage
Actual Study Start Date : March 21, 2018
Actual Primary Completion Date : November 14, 2018
Actual Study Completion Date : November 14, 2018

Arm Intervention/treatment
Experimental: A-101 Topical Solution
Open Label Arm
Drug: A-101 Topical Solution
A-101 Topical Solution applied Day 1, Day 15 and Day 29

Primary Outcome Measures :
  1. Subject Satisfaction [ Time Frame: Day 113 ]
    Subject Satisfaction Questionnaire after treatment with A-101 Topical Solution

Secondary Outcome Measures :
  1. Effectiveness of Treatment [ Time Frame: Day 113 ]
    Effectiveness of treatment as measured by the Physician Lesion Assessment scale. The Physician Lesion Assessment Scale (PLA) is a 4 point scale used by the investigator to assess each subjects SK lesion. PLA=0 (Clear);PLA=1 (Near Clear; not elevated); PLA=2 (Thin;thickness </= 1 mm); PLA=3 (Thick; thickness > 1 mm).

  2. Comparison of Physician Lesion Assessment Score (PLA) to Subject Satisfaction [ Time Frame: Day 113 ]
    Effectiveness of treatment assessed by PLA (4-point scale) compared to subject reported satisfaction with treatment. The PLA scale is a 4 point scale used by the investigator to assess each subject's SK lesion.

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.

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Ages Eligible for Study:   30 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Subject can comprehend and is willing to sign an informed consent for participation in this study.
  2. Male or female between the ages of 30 and 75 years old.
  3. Subject has 3 eligible Seborrheic Keratoses; 2 target SKs must be on the face, and the additional 1 target SK must be on the neck or decolletage.
  4. Subjects must have had cryosurgery for SK removal within the last 6 months and prior to first treatment with A-101 Topical Solution.
  5. Target and non-target SKs must not have been previously treated.
  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 the evaluation of any target or non-target SK or which exposes the subject to an unacceptable risk by study participation

Exclusion Criteria:

  1. Subject has clinically atypical and /or rapidly growing Seborrheic Keratoses.
  2. Subject has current systemic malignancy.
  3. Subject would require the use of any topical treatment (e.g., moisturizers, sunscreens) to any of the target or non-target SKs 12 hours prior to any study visit.
  4. Subject has any current skin disease (e.g., psoriasis, atopic dermatitis, eczema, sun damage), 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

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 identifier (NCT number): NCT03487588

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United States, Pennsylvania
Aclaris Investigational Site
Fort Washington, Pennsylvania, United States, 19034
United States, Tennessee
Aclaris Investigational Site
Knoxville, Tennessee, United States, 37922
United States, Texas
Aclaris Investigational Site
Austin, Texas, United States, 78759
Sponsors and Collaborators
Aclaris Therapeutics, Inc.
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Study Director: David Gordon, MD Aclaris Therapeutics
  Study Documents (Full-Text)

Documents provided by Aclaris Therapeutics, Inc.:
Study Protocol  [PDF] June 18, 2018
Statistical Analysis Plan  [PDF] December 13, 2018

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Responsible Party: Aclaris Therapeutics, Inc. Identifier: NCT03487588    
Other Study ID Numbers: A-101-SEBK-402
First Posted: April 4, 2018    Key Record Dates
Results First Posted: October 2, 2019
Last Update Posted: October 2, 2019
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Keratosis, Actinic
Keratosis, Seborrheic
Skin Diseases
Precancerous Conditions