Study of Safety, Tolerability and Effectiveness of A-101 in Subjects With Seborrheic Keratosis

Study Overview
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Brief Summary
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Evaluate the safety, tolerability of A-101 when applied to seborrheic keratosis lesions on the back of subjects.

Detailed Description
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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.

Official Title
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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

Conditions
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Seborrheic Keratosis (SK)

Intervention / Treatment
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* Drug: A-101 25%
* Drug: A-101 32.5%
* Drug: A-101 40%
* Drug: A-101 Vehicle


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: A-101 25%<br>Low dose group | Drug: A-101 25%<br>* Low Dose Concentration of A-101 applied to one of 4 Target Lesions<br>|
| Active Comparator: A-101 32.5%<br>Mid Dose Group | Drug: A-101 32.5%<br>* Mid Dose Concentration of A-101 applied to one of 4 Target Lesions<br>|
| Active Comparator: A-101 40%<br>High Dose Group | Drug: A-101 40%<br>* High Dose Concentration A-101 applied to one of 4 Target Lesions<br>|
| Placebo Comparator: A-101 Vehicle<br>Placebo group | Drug: A-101 Vehicle<br>* Placebo applied to one of 4 Target Lesions<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Visit 2 to visit 9 (78 days) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | Visit 9 (Day 78) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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SK, Seborrheic Keratosis