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Trial record 9 of 14 for:    "Keratosis seborrheic"

Study of A-101 for the Treatment of Seborrheic Keratosis

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ClinicalTrials.gov Identifier: NCT02260180
Recruitment Status : Completed
First Posted : October 9, 2014
Results First Posted : December 6, 2018
Last Update Posted : December 6, 2018
Sponsor:
Information provided by (Responsible Party):
Aclaris Therapeutics, Inc.

Brief Summary:
The purpose of this study is to evaluate the safety and dose-response of 2 concentrations of A-101 versus a vehicle control in the treatment of seborrheic keratosis.

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

Detailed Description:
The main objective of this study is to evaluate the dose-response relationship of 2 concentrations of A-101 Solution and its matching A-101 Solution Vehicle when applied to seborrheic Keratosis (SK) target lesions on the face. A further objective is to evaluate the safety and efficacy of 2 concentrations of A-101 Solution and its matching A-101 Solution Vehicle when applied topically up to 2 times to SK target lesions on the face.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 119 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 of the Face
Study Start Date : October 2014
Actual Primary Completion Date : March 2015
Actual Study Completion Date : March 2015

Arm Intervention/treatment
Active Comparator: A-101 40%
A-101 40% Topical Solution
Drug: A-101
Topical Solution

Active Comparator: A-101 32.5%
A-101 32.5% Topical Solution
Drug: A-101
Topical Solution

Placebo Comparator: A-101 Vehicle Topical Solution
A-101 0% Topical Solution (vehicle)
Drug: A-101
Topical Solution




Primary Outcome Measures :
  1. Mean of Per-subject Percentages of Target Lesions Judged to be Clear on the Physician's Lesion Assessment (PLA) Score (PLA = 0) at Visit 8. [ Time Frame: Day 106 ]
    The primary efficacy analysis was the mean of per-subject percentages of target lesions judged to be clear on the PLA (PLA = 0) at Visit 8. The PLA is a four point scale from 0 to 3 with 0 being a clear lesion and 3 being the worst lesion. A comparison between each active treatment group and the vehicle treatment group based on the proportion of subjects whose target lesion is judged to be clear on the PLA (PLA = 0) at Visit 8. A higher percentage is a better outcome.


Secondary Outcome Measures :
  1. Mean Change of PLA From Baseline to Visit 8 [ Time Frame: Baseline to Visit 8 ]
    Change from baseline PLA was calculated for each lesion first, then per-subject mean changes from baseline were calculated and served as the basis for the ANCOVA. The physician's Lesion Analysis is a 4 point scale from0 to 3, with 0 being lesion clear and 3 being the most severe lesion. For change from baseline a higher negative score is a better outcome.



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Ages Eligible for Study:   18 Years to 75 Years   (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 Fitzpatrick skin type of 1-4
  3. Subject has a clinical diagnosis of stable clinically typical seborrheic keratosis
  4. Subject has 1 appropriate seborrheic keratosis target lesion, as defined below (Section 5.4), on the face:

    • Have a clinically typical appearance
    • Be treatment naïve
    • Have a Physician's Lesion Assessment (PLA) of ≥2 (Section 6.1.2)
    • Have a longest axis that is ≥7mm and ≤15mm (Section 5.4)
    • Have a longest dimension perpendicular to the longest axis that is ≥7mm and ≤15mm (Section 5.4)
    • 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 on the eyelids
    • Not be within 5mm of the orbital rim
    • Not be covered with hair which, in the investigator's opinion, would interfere with the study medication application or the study evaluations (NB: the study medication may bleach hair)
    • Not be in an intertriginous fold
    • Not be pedunculated.
  5. If the subject is a woman of childbearing potential, she has a negative urine pregnancy test and agrees to use an approved effective method of birth control (Section 8) for the duration of the study
  6. Subject is non-pregnant and non-lactating
  7. 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 the target lesion or which exposes the subject to an unacceptable risk by study participation
  8. Subject is willing and able to follow all study instructions and to attend all study visits
  9. 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
    • Glucocortico-steroids; 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, which 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; 28 days
    • Liquid nitrogen, electrodesiccation, curettage, imiquimod, 5-fluorouracil, or ingenol mebutate; 60 days
    • Glucocortico-steroids or antibiotics; 14 days
  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, which 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) which, in the investigator's opinion, 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): NCT02260180


Locations
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United States, Oregon
Oregon Medical Research Center
Portland, Oregon, United States, 97223
United States, Pennsylvania
Philadelphia Institute of Dermatology
Fort Washington, Pennsylvania, United States, 19034
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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Study Director: Brian Beger, BS 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: NCT02260180     History of Changes
Other Study ID Numbers: A-101-SEBK-203
First Posted: October 9, 2014    Key Record Dates
Results First Posted: December 6, 2018
Last Update Posted: December 6, 2018
Last Verified: November 2018

Additional relevant MeSH terms:
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Keratosis, Actinic
Keratosis
Keratosis, Seborrheic
Skin Diseases
Precancerous Conditions
Neoplasms
Pharmaceutical Solutions