A Randomized, Vehicle-Controlled Study of 2 Concentrations of A-101 for the Treatment of Seborrheic Keratosis



Status:Completed
Conditions:Dermatology
Therapuetic Areas:Dermatology / Plastic Surgery
Healthy:No
Age Range:18 - Any
Updated:10/3/2018
Start Date:May 15, 2017
End Date:April 3, 2018

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A Phase 2 Randomized, Double-Blind, Vehicle-Controlled, Parallel Group Study of the Safety and Effectiveness of A-101(Hydrogen Peroxide) Topical Solution in Subjects With Seborrheic Keratosis Lesions on the Trunk, Extremities, and Face

The primary objective of this study is to evaluate the safety and effectiveness of 2
concentrations of A-101 compared to Vehicle for the treatment of 4 seborrheic keratosis (SK)
Target Lesions on the trunk, extremities and face.

The primary objective of this study is to evaluate the safety and effectiveness of 2
concentrations of A-101 compared to Vehicle for the treatment of 4 seborrheic keratosis (SK)
Target Lesions on the trunk, extremities and face.

The secondary objectives of this study include duration of response of A-101. During the
study, the investigator will identify 4 eligible SK Target Lesions on each subject on the
trunk, extremities and face. For each subject, at least 1 SK Target Lesion must be on the
face and at least 1 Target Lesion must be on the trunk or extremities. The Target Lesions
will be treated at a maximum of two treatment visits.

Inclusion Criteria:

1. Subject is able to comprehend and is willing to sign an informed consent for
participation in this study.

2. Male or female ≥ 18 years old.

3. Subject has a clinical diagnosis of stable clinically typical seborrheic keratosis.

4. Subject has 4 appropriate seborrheic keratosis Target Lesions on the trunk,
extremities and face, with at least 1 Target Lesion on the face and at least 1 Target
Lesion on the trunk or extremities. The 4 identified Target Lesions must meet the
requirements as defined below:

1. Have a clinically typical appearance

2. Have a Physician's Lesion Assessment of ≥ 2

3. Length that is ≥ 5mm and ≤ 15mm

4. Width that is ≥ 5mm and ≤ 15 mm

5. Thickness that is ≤ 2mm

6. Be a discreet lesion

7. Be the only SK lesion present when centered in the area outlined by the provided
circular template

8. Not be covered with hair which, the in the investigator's opinion, would
interfere with the study medication treatment or the study evaluations

9. Not be in the intertriginous fold

10. Not be on the eyelids

11. Not be within 5mm of the orbital rim

12. Not be pedunculated

5. Subject chemistry and complete blood count results are within normal limits. If any of
the laboratory values are outside normal range, the treating investigator must assess
the value/s as NOT clinically significant and document this in the patient's medical
chart in order for the subject to be eligible for randomization.

6. Woman of childbearing potential must have a negative urine pregnancy test within 14
days of the first application of study drug and agree to use an active method of birth
control for the duration of the study.

7. Subject is non-pregnant and non-lactating.

8. Subject is in good general health and free of any known disease state or physical
condition which, in the investigator's opinion, might impair the evaluation of any
Target Lesion or which exposes the subject to an unacceptable risk by study
participation.

9. Subject is willing and able to follow all study instructions and to attend all study
visits.

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 Lesser
- Trelat).

3. Subject has current systemic malignancy.

4. Subject has used any of the following systemic therapies within the specified period
prior to Visit 1:

- Retinoids; 180 days

- Corticosteroids; 28 days

- Anti-metabolites (e.g., methotrexate); 28 days

5. Subject has used any of the following topical therapies within the specified period
prior to Visit 1 on, or in a proximity to any Target Lesion, that in the
investigator's opinion interferes with the study medication treatment or the study
assessments:

- LASER, light or other energy based therapy (e.g., intense pulsed light [IPL],
photo-dynamic therapy [PDT]; 180 days

- Liquid nitrogen, electrodesiccation, curettage, imiquimod, 5-FU, or ingenol
mebutate; 60 days

- Hydrogen peroxide: 90 days

- Retinoids; 28 days

- Microdermabrasion or superficial chemical peels; 14 days

- Corticosteroids or antibiotics; 14 days

6. Subject would require the use of any topical treatment (e.g. moisturizers, sunscreen)
to any of the Target Lesions 12 hours prior to any study visit.

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 any Target Lesion that, in the investigator's
opinion, interferes with the study medication treatment or the study assessments:

- Cutaneous malignancy; 180 days

- Sunburn; currently

- Pre-malignancy (e.g. actinic keratosis); currently

- Body art (e.g. tattoos, piercing, etc.); currently

- Excessive tan; currently. The use of self-tanning lotions/sprays are prohibited.

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), 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. Participation in another therapeutic investigational drug trial in which
administration of an investigational study medication occurred with 30 days prior to
Visit 1.
We found this trial at
9
sites
Philadelphia, Pennsylvania 19104
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Austin, Texas 78759
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Fort Washington, Pennsylvania 19034
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Fort Washington, PA
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Greenville, South Carolina 29607
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Greenville, SC
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10215 Kingston Pike
Knoxville, Tennessee 37922
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Knoxville, TN
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4500 Biscayne Boulevard
Miami, Florida 33137
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Miami, FL
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New York, New York 10003
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New York, NY
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Newnan, Georgia 30263
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Newnan, GA
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Washington, District of Columbia 20037
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Washington,
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