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Trial record 8 of 14 for:    "Keratosis seborrheic"

A Randomized, Vehicle-Controlled Study of 2 Concentrations of A-101 for the Treatment of Seborrheic Keratosis

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ClinicalTrials.gov Identifier: NCT03148691
Recruitment Status : Completed
First Posted : May 11, 2017
Results First Posted : May 6, 2019
Last Update Posted : May 6, 2019
Sponsor:
Information provided by (Responsible Party):
Aclaris Therapeutics, Inc.

Brief Summary:
The primary objective of this study is to evaluate the safety and effectiveness of 2 concentrations of A-101 compared to Vehicle for the treatment of 4 seborrheic keratosis (SK) Target Lesions on the trunk, extremities and face.

Condition or disease Intervention/treatment Phase
Seborrheic Keratosis Drug: A-101 Phase 2

Detailed Description:

The primary objective of this study is to evaluate the safety and effectiveness of 2 concentrations of A-101 compared to Vehicle for the treatment of 4 seborrheic keratosis (SK) Target Lesions on the trunk, extremities and face.

The secondary objectives of this study include duration of response of A-101. During the study, the investigator will identify 4 eligible SK Target Lesions on each subject on the trunk, extremities and face. For each subject, at least 1 SK Target Lesion must be on the face and at least 1 Target Lesion must be on the trunk or extremities. The Target Lesions will be treated at a maximum of two treatment visits.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 253 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 2 Randomized, Double-Blind, Vehicle-Controlled, Parallel Group Study of the Safety and Effectiveness of A-101(Hydrogen Peroxide) Topical Solution in Subjects With Seborrheic Keratosis Lesions on the Trunk, Extremities, and Face
Actual Study Start Date : May 17, 2017
Actual Primary Completion Date : February 28, 2018
Actual Study Completion Date : April 3, 2018

Arm Intervention/treatment
Placebo Comparator: Vehicle
Vehicle Topical Solution
Drug: A-101
Topical Solution

Active Comparator: A-101 Low Dose
A-101 Low Dose Topical Solution
Drug: A-101
Topical Solution

Active Comparator: A-101 High Dose
A-101 High DoseTopical Solution
Drug: A-101
Topical Solution




Primary Outcome Measures :
  1. Mean of Per Subject Percentages of Target Lesions Judged to be Clear (PWA=0) at Visit 8 [ Time Frame: Day 106 ]

    Mean of per subject percentages of target lesions judged to be clear (PWA=0) at Visit 8

    Grade Descriptor

    0 Clear: no visible seborrheic keratosis lesion

    1. Near Clear: a visible seborrheic keratosis lesion with a surface appearance different from the surrounding skin (not elevated)
    2. Thin: a visible seborrheic keratosis lesion (thickness ≤ 1 mm)
    3. Thick: a visible seborrheic keratosis lesion (thickness > 1 mm)



Information from the National Library of Medicine

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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 able to comprehend and is willing to sign an informed consent for participation in this study.
  2. Male or female ≥ 18 years old.
  3. Subject has a clinical diagnosis of stable clinically typical seborrheic keratosis.
  4. Subject has 4 appropriate seborrheic keratosis Target Lesions on the trunk, extremities and face, with at least 1 Target Lesion on the face and at least 1 Target Lesion on the trunk or extremities. The 4 identified Target Lesions must meet the requirements as defined below:

    1. Have a clinically typical appearance
    2. Have a Physician's Lesion Assessment of ≥ 2
    3. Length that is ≥ 5mm and ≤ 15mm
    4. Width that is ≥ 5mm and ≤ 15 mm
    5. Thickness that is ≤ 2mm
    6. Be a discrete lesion
    7. Be the only SK lesion present when centered in the area outlined by the provided circular template
    8. Not be covered with hair which, the in the investigator's opinion, would interfere with the study medication treatment or the study evaluations
    9. Not be in the intertriginous fold
    10. Not be on the eyelids
    11. Not be within 5mm of the orbital rim
    12. Not be pedunculated
  5. Subject chemistry and complete blood count results are within normal limits. If any of the laboratory values are outside normal range, the treating investigator must assess the value/s as NOT clinically significant and document this in the subject's medical chart in order for the subject to be eligible for randomization.
  6. Woman of childbearing potential must have a negative urine pregnancy test within 14 days of the first application of study drug and agree to use an active method of birth control for the duration of the study.
  7. Subject is non-pregnant and non-lactating.
  8. 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 Lesion or which exposes the subject to an unacceptable risk by study participation.
  9. Subject is willing and able to follow all study instructions and to attend all study visits.

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 Leser - Trelat).
  3. Subject has current systemic malignancy.
  4. Subject has used any of the following systemic therapies within the specified period prior to Visit 1:

    • Retinoids; 180 days
    • Corticosteroids; 28 days
    • Anti-metabolites (e.g., methotrexate); 28 days
  5. Subject has used any of the following topical therapies within the specified period prior to Visit 1 on, 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; 180 days
    • Liquid nitrogen, electrodesiccation, curettage, imiquimod, 5-Fluorouracil, or ingenol mebutate; 60 days
    • Hydrogen peroxide: 90 days
    • Retinoids; 28 days
    • Microdermabrasion or superficial chemical peels; 14 days
    • Corticosteroids or antibiotics; 14 days
  6. Subject would require the use of any topical treatment (e.g. moisturizers, sunscreen) to any of the Target Lesions 12 hours prior to any study visit.
  7. Subject currently has or has had any of the following within the specified period prior to Visit 1 on or in a proximity to any Target Lesion that, in the investigator's opinion, interferes with the study medication treatment or the study assessments:

    • Cutaneous malignancy; 180 days
    • Sunburn; currently
    • Pre-malignancy (e.g. actinic keratosis); currently
    • Body art (e.g. tattoos, piercing, etc.); currently
    • Excessive tan; currently. The use of self-tanning lotions/sprays are prohibited.
  8. Subject has a history of sensitivity to any of the ingredients in the study medications.
  9. 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.
  10. Participation in another therapeutic investigational drug trial in which administration of an investigational study medication occurred within 30 days prior to Visit 1.

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): NCT03148691


Locations
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United States, District of Columbia
Center for Dermatology and Dermatologic Surgery
Washington, District of Columbia, United States, 20037
United States, Florida
Baumann Research Institute
Miami, Florida, United States, 33137
United States, Georgia
MedaPhase, Inc
Newnan, Georgia, United States, 30263
United States, New York
Union Square Laser Dermatology
New York, New York, United States, 10003
United States, Pennsylvania
Philadelphia Institute - Dermatology
Fort Washington, Pennsylvania, United States, 19034
Perelman Center for Advanced Medicine
Philadelphia, Pennsylvania, United States, 19104
United States, South Carolina
Greenville Dermatology
Greenville, South Carolina, United States, 29607
United States, Tennessee
The Skin Wellness Center, PC Clinical Research Division
Knoxville, Tennessee, United States, 37922
United States, Texas
DermResearch Inc
Austin, Texas, United States, 78759
Sponsors and Collaborators
Aclaris Therapeutics, Inc.
Investigators
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Study Director: Stuart D Shanler, MD Aclaris Therapeutics, Inc.
  Study Documents (Full-Text)

Documents provided by Aclaris Therapeutics, Inc.:

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Responsible Party: Aclaris Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT03148691     History of Changes
Other Study ID Numbers: A-101-SEBK-204
First Posted: May 11, 2017    Key Record Dates
Results First Posted: May 6, 2019
Last Update Posted: May 6, 2019
Last Verified: May 2019
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
Keratosis, Actinic
Keratosis, Seborrheic
Skin Diseases
Precancerous Conditions
Neoplasms
Pharmaceutical Solutions