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Trial record 11 of 14 for:    "Keratosis seborrheic"

An Open-Label Safety Study of A-101 Solution

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ClinicalTrials.gov Identifier: NCT02667288
Recruitment Status : Completed
First Posted : January 28, 2016
Results First Posted : November 17, 2017
Last Update Posted : February 7, 2018
Sponsor:
Information provided by (Responsible Party):
Aclaris Therapeutics, Inc.

Brief Summary:
This is an open-label safety study. During this study, the investigator will identify 4 eligible SK Target Lesions on each subject on the trunk, extremities and face.

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

Detailed Description:
This is an open-label safety 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 a maximum of 4 times.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 147 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label Study of the Safety 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

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



Primary Outcome Measures :
  1. Proportion of Subjects With Lesion Clearance [ Time Frame: Study day 148 ]
    Proportion of subjects for whom all target lesions were judged to be clear on the Physician Lesion Assessment (PWA) Scale. The PWA scale is a 4 point scale used by the investigator to assess each subject target SK Lesion.


Secondary Outcome Measures :
  1. Per Subject Percent of Lesion Clearance [ Time Frame: Day 148 ]
    Physician Lesion Assessment (PWA) average Per-Subject Percent of target lesions judged to be clear at Visit 12 in the per protocol population. The PWA scale is a 4 point scale used by the investigator to assess the subject's Target SK lesions.



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 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): NCT02667288


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

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Responsible Party: Aclaris Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT02667288     History of Changes
Other Study ID Numbers: A-101-SEBK-303
First Posted: January 28, 2016    Key Record Dates
Results First Posted: November 17, 2017
Last Update Posted: February 7, 2018
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Keratosis, Actinic
Keratosis
Keratosis, Seborrheic
Skin Diseases
Precancerous Conditions
Neoplasms
Pharmaceutical Solutions