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Trial record 4 of 25 for:    aclaris

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

Tracking Information
First Submitted Date  ICMJE March 2, 2018
First Posted Date  ICMJE April 4, 2018
Results First Submitted Date  ICMJE September 12, 2019
Results First Posted Date  ICMJE October 2, 2019
Last Update Posted Date October 2, 2019
Actual Study Start Date  ICMJE March 21, 2018
Actual Primary Completion Date November 14, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 3, 2018)
Subject Satisfaction [ Time Frame: Day 113 ]
Subject Satisfaction Questionnaire after treatment with A-101 Topical Solution
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 1, 2019)
  • 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).
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: April 3, 2018)
  • Effectiveness of Treatment [ Time Frame: Day 113 ]
    Effectiveness of treatment as measured by the Physician Lesion Assessment scale. The Physician Lesion Assessment Scale is a 4 point scale used by the investigator to assess each subjects SK lesion. A PLA=0 reflects that the subject SK lesion has cleared. Lower PLA scores reflect a response to treatment.
  • 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE An A Study Assessing Subject Satisfaction With A-101 Topical Solution for Seborrheic Keratoses
Official Title  ICMJE 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
Brief Summary This study is an open-label study designed to evaluate subject's satisfaction after treatment of seborrheic keratoses with A-101 40%.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Seborrheic Keratosis
Intervention  ICMJE Drug: A-101 Topical Solution
A-101 Topical Solution applied Day 1, Day 15 and Day 29
Study Arms  ICMJE Experimental: A-101 Topical Solution
Open Label Arm
Intervention: Drug: A-101 Topical Solution
Publications * Not Provided

*   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: September 20, 2018)
41
Original Estimated Enrollment  ICMJE
 (submitted: April 3, 2018)
30
Actual Study Completion Date  ICMJE November 14, 2018
Actual Primary Completion Date November 14, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 30 Years to 75 Years   (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 NCT03487588
Other Study ID Numbers  ICMJE A-101-SEBK-402
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Aclaris Therapeutics, Inc.
Study Sponsor  ICMJE Aclaris Therapeutics, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: David Gordon, MD Aclaris Therapeutics
PRS Account Aclaris Therapeutics, Inc.
Verification Date March 2018

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