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Dose-Response Profile of A-101 in Subjects With Seborrheic Keratosis

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ClinicalTrials.gov Identifier: NCT02160626
Recruitment Status : Completed
First Posted : June 11, 2014
Results First Posted : December 7, 2018
Last Update Posted : January 3, 2019
Sponsor:
Information provided by (Responsible Party):
Aclaris Therapeutics, Inc.

Brief Summary:
The main objective of this study is to evaluate the dose-response relationship of two concentrations of A-101 solution when applied to individual seborrheic keratosis (SK) lesions (target lesions) compared with a matching A-101 Solution Vehicle.

Condition or disease Intervention/treatment Phase
Seborrheic Keratosis Drug: A-101 Vehicle Drug: A-101 (40) Topical Solution Drug: A-101 (32.5) Topical Solution Phase 2

Detailed Description:

The main objective of this study is to evaluate the dose-response relationship of two concentrations of A-101solution when applied to individual seborrheic keratosis (SK) lesions (target lesions) compared with a matching A-101 Solution Vehicle.

Each subject will have 4 target lesions on the trunk/extremities.

A further objective is to evaluate the safety and efficacy of two concentrations of A-101 solution and its matching vehicle when applied to SK target lesions on the trunk/extremities.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 172 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Vehicle Controlled, Parallel Group Study of the Dose-Response Profile of A-101 Topical Solution in Subjects With Seborrheic Keratosis.
Study Start Date : June 2014
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Arm Intervention/treatment
Placebo Comparator: A-101 Vehicle
A-101 Vehicle (placebo) Topical Solution
Drug: A-101 Vehicle
Placebo control

Active Comparator: A-101 (40) Topical Solution
A-101 (40) Topical Solution - high dose
Drug: A-101 (40) Topical Solution
A-101 (40) Topical Solution - high dose

Active Comparator: A-101 (32.5) Topical Solution
A-101 (32.5) Topical Solution - low dose
Drug: A-101 (32.5) Topical Solution
A-101 (32.5) Topical Solution - low dose




Primary Outcome Measures :
  1. Mean Per Subject Percentage Target Lesions Judged Clear by the Physician's Lesion Assessment (PLA) [ Time Frame: Baseline, visit 8 ]
    Mean of per-subject percentages of target lesions judged to be clear on the PLA (PLA = 0) at end of study (Visit 8). The PLA is a four point scale from 0 being clear to 3 being most severe lesion.


Secondary Outcome Measures :
  1. Mean Change From Baseline to Visit 8 in the Physician's Lesion Assessment [ Time Frame: Baseline, visit 8 ]

    Change from baseline PLA will be calculated for each lesion first, then per-subject mean changes from baseline will be calculated.

    The PLA is a score on a four scale from 0 to 3 with 0 being clear and 3 being the most severe, a lower score indicating a better result. For the mean change in this score, a larger mean change is a better result.


  2. Proportion of Subjects Who Had at Least 3 of 4 Target Lesions Judged to be Clear on the Physician Lesion Assessment (PLA =0) at Visit 8. [ Time Frame: Baseline, visit 8 ]
    Proportion of Subjects who had at least 3 of 4 target lesions judged to be clear on the Physician Lesion Assessment (PLA =0) at visit 8. The PLA is a 4 point scale evaluating the severity of a lesion with 0 being clear and 3 being the most severe.



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. Subject has a clinical diagnosis of stable clinically typical seborrheic keratosis
  3. Subject has 4 appropriate seborrheic keratosis target lesions, as defined below, on the trunk/extremities:

    • Have a clinically typical appearance
    • Be treatment naïve
    • Have a Physician Lesion Assessment (PLA) of ≥2
    • Have a longest axis that is ≥7mm and ≤15mm
    • Have a longest dimension perpendicular to the longest axis that is ≥7mm and ≤15mm
    • Have a thickness that is ≤2mm
    • Be a discrete lesion
    • Be, when centered in the area outlined by the provided 3cm diameter circular template, the only seborrheic keratosis lesion present
    • Not be in an intertriginous fold
    • Not be in an area where clothing, such as a bra, might cause physical irritation
    • 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 form 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 (ICF).

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 a current systemic malignancy
  4. Subject has a history of keloid formation or hypertrophic scarring
  5. Subject has used any of the following systemic therapies within the specified period prior to Visit 1:

    • Retinoids; 180 days
    • Glucocorticosteroids; 28 days
    • Anti-metabolites (e.g., methotrexate); 28 days
  6. Subject has used any of the following topical therapies within the specified period prior to Visit 1 on, or in a proximity to the target lesion, that in the investigator's opinion, interferes with the application of the study medication or the study assessments:

    • LASER, light (e.g., intense pulsed light (IPL), photo-dynamic therapy (PDT)) or other energy based therapy; 180 days
    • Retinoids; 90 days
    • Liquid nitrogen, electrodesiccation, curettage, imiquimod, 5-fluorouracil, or ingenol mebutate; 60 days
    • Glucocorticosteroids or antibiotics; 14 days
    • Moisturizers/emollients, sunscreens; 12 hours
  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 the target lesion that, in the investigator's opinion, interferes with the application of the study medication or the study assessments:

    • A cutaneous malignancy; 180 days
    • Experienced a sunburn; 28 days
    • A pre-malignancy (e.g., actinic keratosis); currently
    • Body art (e.g., tattoos, piercing, etc.); currently
    • Excessive tan; currently
  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, 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
  10. Subject has participated in an 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): NCT02160626


Locations
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United States, Georgia
Gwinnett Clinical Research Center, Inc.
Snellville, Georgia, United States, 30078
United States, Michigan
Michigan Center for Research Corp.
Clinton Township, Michigan, United States, 48038
United States, Oregon
Oregon Medical Research Center
Portland, Oregon, United States, 97223
United States, Texas
DermReseach, Inc.
Austin, Texas, United States, 78759
United States, Virginia
The Education & Research Foundation, Inc.
Lynchburg, Virginia, United States, 24501
Sponsors and Collaborators
Aclaris Therapeutics, Inc.
Investigators
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Principal Investigator: Jonathan S Weiss, MD Gwinnett Clinical Research Center, Inc.
Principal Investigator: Janet Dubois, MD Derm Research, PLLC
Principal Investigator: David C Wilson, MD The Education & Research Foundation, Inc.
Principal Investigator: Daniel M Stewart, DO Michigan Center for Research Corp.
Principal Investigator: Andrew Blauvelt, MD, MBA Oregon Medical Research Center
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Responsible Party: Aclaris Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT02160626    
Other Study ID Numbers: A-101-SEBK-202
First Posted: June 11, 2014    Key Record Dates
Results First Posted: December 7, 2018
Last Update Posted: January 3, 2019
Last Verified: December 2018
Keywords provided by Aclaris Therapeutics, Inc.:
Seborrheic keratosis
A101
Additional relevant MeSH terms:
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Keratosis, Actinic
Keratosis
Keratosis, Seborrheic
Skin Diseases
Precancerous Conditions
Neoplasms
Pharmaceutical Solutions