A Randomized, Double-Blind, Vehicle-Controlled Study in Subjects With Seborrheic Keratosis
Status: | Completed |
---|---|
Conditions: | Dermatology |
Therapuetic Areas: | Dermatology / Plastic Surgery |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 2/8/2018 |
Start Date: | January 2016 |
End Date: | October 2016 |
A Randomized, Double-Blind, Vehicle-Controlled, PArallel Group Study of the Safety and Effectiveness of A-101 Solution 40% in Subjects With Seborrheic Keratosis on the Trunk, Extremities and Face.
This is a randomized, double-blind, vehicle-controlled, parallel group study.
This is a randomized, double-blind, vehicle-controlled, parallel group study. During this
study, the investigator will identify 4 eligible SK Target Lesions on each subject on the
trunk, extremities and face.
study, the investigator will identify 4 eligible SK Target Lesions on each subject on the
trunk, extremities and face.
Inclusion Criteria:
1. Subject is at least 18 years of age
2. Clinical diagnosis of stable clinically typical seborrheic keratosis
3. Subject has 4 appropriate seborrheic keratosis Target Lesions on the trunk,
extremities and face that each are eligible for treatment as defined below:
- Have a clinically typical appearance
- Have a PLA of 2 or greater and be a discrete lesion
- Not be covered with hair which, in the investigator's opinion, would interfere
with the study medication treatment or the study evaluations
- Not be in an intertriginous fold
- Not be on the eyelids
- Not be within 5mm of the orbital rim
- Not be pedunculated
4. If the subject is a woman of childbearing potential, she has a negative urine
pregnancy test and agrees to use an active method of birth control for the duration of
the study
5. Subject is non-pregnant and non-lactating
6. 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 any Target
Lesion or which exposes the subject to an unacceptable risk by study participation
7. Subject is willing and able to follow all study instructions and to attend all study
visits
8. Subject is able to comprehend and willing to sign an Informed Consent Form.
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 a current systemic malignancy 4. Subject has used any of the
following systemic therapies within the specified period prior to enrollment:
- Retinoids; 180 days
- Glucocortico-steroids;
- Anti-metabolites (e.g., methotrexate); 5. Subject has used any of the following
topical therapies within the specified period 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, photo-dynamic
therapy;
- Liquid nitrogen, electrodesiccation, curettage, imiquimod, 5-flurouracil, or ingenol
mebutate;
- Retinoids;
- Microdermabrasion or superficial chemical peels;
- Glucocortico-steroids or antibiotics 6. Subject currently has or has had any of the
following within the specified period or in a proximity to any Target Lesion that, in
the investigator's opinion, interferes with the study medication treatment or the
study assessments:
- A cutaneous malignancy;
- A sunburn; currently
- A pre-malignancy (e.g., actinic keratosis); currently
- Body art (e.g., tattoos, piercing, etc.); currently
- Excessive tan; currently 7. Subject has a history of sensitivity to any of the
ingredients in the study medications 8. Subject has any current skin disease (e.g.,
psoriasis, atopic dermatitis, eczema, sun damage, etc.), 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 9. Subject has participated in an investigational drug trial in which
administration of an investigational study medication occurred within 30 days prior to
enrollment.
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