- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01986920
Study of Safety, Tolerability and Effectiveness of A-101 in Subjects With Seborrheic Keratosis
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 Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Locations
-
-
Texas
-
Austin, Texas, United States, 78759
- Dermresearch, Inc.
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: A-101 25%
Low dose group
|
Low Dose Concentration of A-101 applied to one of 4 Target Lesions
|
Active Comparator: A-101 32.5%
Mid Dose Group
|
Mid Dose Concentration of A-101 applied to one of 4 Target Lesions
|
Active Comparator: A-101 40%
High Dose Group
|
High Dose Concentration A-101 applied to one of 4 Target Lesions
|
Placebo Comparator: A-101 Vehicle
Placebo group
|
Placebo applied to one of 4 Target Lesions
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mean Change in Physician Lesion Assessment Scale
Time Frame: Visit 2 to visit 9 (78 days)
|
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. |
Visit 2 to visit 9 (78 days)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Subject's Self Assessment Scale
Time Frame: Visit 9 (Day 78)
|
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).
|
Visit 9 (Day 78)
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Janet Dubois, MD, Derm Research, PLLC
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- A-101-SEBK-201
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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