Study of Safety, Tolerability and Effectiveness of A-101 in Subjects With Seborrheic Keratosis
Primary Purpose
Seborrheic Keratosis (SK)
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
A-101 25%
A-101 32.5%
A-101 40%
A-101 Vehicle
Sponsored by
About this trial
This is an interventional treatment trial for Seborrheic Keratosis (SK) focused on measuring SK, Seborrheic Keratosis
Eligibility Criteria
Inclusion Criteria:
- Is at least 18 years of age
- Has a clinical diagnosis of stable clinically typical seborrheic keratosis
- Has at least 4 appropriate seborrheic keratosis target lesions on the back
- If subject is a women of childbearing potential, she must have a negative urine pregnancy test and must agree to use an active form of birth control for the duration of the study
- Is non-pregnant and non-lactating
- Is in good general health and free of any 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
- Is willing and able to follow all study instructions and to attend all study visits
- Is able to comprehend and willing to sign an Informed Consent Form (ICF).
Exclusion Criteria:
- Has clinically atypical and/or rapidly growing seborrheic keratosis lesions
- Has presence of multiple eruptive seborrheic keratosis lesions (Sign of Leser-Trelat)
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
Has used any of the following topical therapies on the treatment area within the specified period prior to Visit 1:
- 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
- Has had any LASER, light (e.g., intense pulsed light (IPL), photo-dynamic therapy (PDT)) or other energy based therapy on the treatment area within 180 days prior to Visit 1
- Has a history of keloid formation or hypertrophic scarring
- Has a current systemic malignancy
- Has a history of, within the 180 days prior to Visit 1, or has a current cutaneous malignancy on the treatment area
- Has a current pre-malignancy (e.g., actinic keratosis) on the treatment area
- Has had body art (e.g., tattoos, piercing, sculpting, etc.) or any other invasive, non-therapeutic procedure performed on the treatment area that, in the opinion of the investigator, might put the subject at undue risk or interfere with the study conduct or evaluations
- Has excessive tan on the treatment area that, in the opinion of the investigator, might put the subject at undue risk or interfere with the study conduct or evaluations
- Has experienced a sunburn on the treatment area within the previous 4 weeks
- Has a history of sensitivity to any of the ingredients in the study medications
- Has any current skin disease (e.g., psoriasis, atopic dermatitis, eczema, sun damage, etc.), or condition (e.g., sunburn, tattoos, excessive hair, open wounds on the back) that, in the opinion of the investigator, might put the subject at undue risk or interfere with the study conduct or evaluations
- Has participated in an investigational drug trial in which administration of an investigational study medication occurred within 30 days prior to Visit 1.
Sites / Locations
- DermResearch, Inc.
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
Active Comparator
Active Comparator
Placebo Comparator
Arm Label
A-101 25%
A-101 32.5%
A-101 40%
A-101 Vehicle
Arm Description
Low dose group
Mid Dose Group
High Dose Group
Placebo group
Outcomes
Primary Outcome Measures
Mean Change in Physician Lesion Assessment Scale
Mean Change in Score on the Physician Lesion Assessment Scale (PLA) of each Target Lesion. The PLAS is a four point scale from 0-3 with 0 being clear and 3 being the worst lesion.
The primary effectiveness will consist of the mean change from Visit 2 to Visit 9 in PLA performed using Analysis of Covariance (ANCOVA) with Visit 2 PLAS as the covariate. Comparisons between vehicle and each active treatment group will be performed within the model using least-squares means and the common error term.
Secondary Outcome Measures
Subject's Self Assessment Scale
Subjects self assessment of the condition of their lesions based on a scale of Clear (Grade 0), Mild (Grade 1), Moderate (Grade 2), Severe (Grade 3).
Full Information
NCT ID
NCT01986920
First Posted
November 6, 2013
Last Updated
November 15, 2018
Sponsor
Aclaris Therapeutics, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT01986920
Brief Title
Study of Safety, Tolerability and Effectiveness of A-101 in Subjects With Seborrheic Keratosis
Official Title
A Randomized, Double-Blind, Vehicle-Controlled, Within-Subject, Comparison Study of the Safety, Tolerability, And Effectiveness of A-101 Topical Solution in Subjects With Seborrheic Keratosis
Study Type
Interventional
2. Study Status
Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
October 22, 2013 (undefined)
Primary Completion Date
February 25, 2014 (Actual)
Study Completion Date
February 25, 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Aclaris Therapeutics, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Evaluate the safety, tolerability of A-101 when applied to seborrheic keratosis lesions on the back of subjects.
Detailed Description
The main objective of this study is to evaluate the safety, effectiveness and tolerability of three concentrations of A-101 25%, 32.5%, and 40%, when applied to individual seborrheic keratosis target lesions on the back compared with a matching A-101 vehicle.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Seborrheic Keratosis (SK)
Keywords
SK, Seborrheic Keratosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Model Description
The three tests solutions and the placebo solution are each applied topically to 1 of 4 target lesions on the backs of each subject (determined by the randomization schedule). If needed a second treatment may be applied at Visit 5.
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
35 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A-101 25%
Arm Type
Active Comparator
Arm Description
Low dose group
Arm Title
A-101 32.5%
Arm Type
Active Comparator
Arm Description
Mid Dose Group
Arm Title
A-101 40%
Arm Type
Active Comparator
Arm Description
High Dose Group
Arm Title
A-101 Vehicle
Arm Type
Placebo Comparator
Arm Description
Placebo group
Intervention Type
Drug
Intervention Name(s)
A-101 25%
Intervention Description
Low Dose Concentration of A-101 applied to one of 4 Target Lesions
Intervention Type
Drug
Intervention Name(s)
A-101 32.5%
Intervention Description
Mid Dose Concentration of A-101 applied to one of 4 Target Lesions
Intervention Type
Drug
Intervention Name(s)
A-101 40%
Intervention Description
High Dose Concentration A-101 applied to one of 4 Target Lesions
Intervention Type
Drug
Intervention Name(s)
A-101 Vehicle
Intervention Description
Placebo applied to one of 4 Target Lesions
Primary Outcome Measure Information:
Title
Mean Change in Physician Lesion Assessment Scale
Description
Mean Change in Score on the Physician Lesion Assessment Scale (PLA) of each Target Lesion. The PLAS is a four point scale from 0-3 with 0 being clear and 3 being the worst lesion.
The primary effectiveness will consist of the mean change from Visit 2 to Visit 9 in PLA performed using Analysis of Covariance (ANCOVA) with Visit 2 PLAS as the covariate. Comparisons between vehicle and each active treatment group will be performed within the model using least-squares means and the common error term.
Time Frame
Visit 2 to visit 9 (78 days)
Secondary Outcome Measure Information:
Title
Subject's Self Assessment Scale
Description
Subjects self assessment of the condition of their lesions based on a scale of Clear (Grade 0), Mild (Grade 1), Moderate (Grade 2), Severe (Grade 3).
Time Frame
Visit 9 (Day 78)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Is at least 18 years of age
Has a clinical diagnosis of stable clinically typical seborrheic keratosis
Has at least 4 appropriate seborrheic keratosis target lesions on the back
If subject is a women of childbearing potential, she must have a negative urine pregnancy test and must agree to use an active form of birth control for the duration of the study
Is non-pregnant and non-lactating
Is in good general health and free of any 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
Is willing and able to follow all study instructions and to attend all study visits
Is able to comprehend and willing to sign an Informed Consent Form (ICF).
Exclusion Criteria:
Has clinically atypical and/or rapidly growing seborrheic keratosis lesions
Has presence of multiple eruptive seborrheic keratosis lesions (Sign of Leser-Trelat)
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
Has used any of the following topical therapies on the treatment area within the specified period prior to Visit 1:
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
Has had any LASER, light (e.g., intense pulsed light (IPL), photo-dynamic therapy (PDT)) or other energy based therapy on the treatment area within 180 days prior to Visit 1
Has a history of keloid formation or hypertrophic scarring
Has a current systemic malignancy
Has a history of, within the 180 days prior to Visit 1, or has a current cutaneous malignancy on the treatment area
Has a current pre-malignancy (e.g., actinic keratosis) on the treatment area
Has had body art (e.g., tattoos, piercing, sculpting, etc.) or any other invasive, non-therapeutic procedure performed on the treatment area that, in the opinion of the investigator, might put the subject at undue risk or interfere with the study conduct or evaluations
Has excessive tan on the treatment area that, in the opinion of the investigator, might put the subject at undue risk or interfere with the study conduct or evaluations
Has experienced a sunburn on the treatment area within the previous 4 weeks
Has a history of sensitivity to any of the ingredients in the study medications
Has any current skin disease (e.g., psoriasis, atopic dermatitis, eczema, sun damage, etc.), or condition (e.g., sunburn, tattoos, excessive hair, open wounds on the back) that, in the opinion of the investigator, might put the subject at undue risk or interfere with the study conduct or evaluations
Has participated in an investigational drug trial in which administration of an investigational study medication occurred within 30 days prior to Visit 1.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janet Dubois, MD
Organizational Affiliation
Derm Research, PLLC
Official's Role
Principal Investigator
Facility Information:
Facility Name
DermResearch, Inc.
City
Austin
State/Province
Texas
ZIP/Postal Code
78759
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
http://www.aclaristx.com
Description
Study Sponsor Website
Learn more about this trial
Study of Safety, Tolerability and Effectiveness of A-101 in Subjects With Seborrheic Keratosis
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