Active-Controlled Study to Assess the Efficacy and Safety of DFD-05 in Subjects With Common Warts



Status:Completed
Conditions:Dermatology
Therapuetic Areas:Dermatology / Plastic Surgery
Healthy:No
Age Range:18 - 50
Updated:8/17/2016
Start Date:January 2016
End Date:August 2016

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DFD05 vs. Active01 in the treatment of common warts


Inclusion Criteria:

1. Subjects, any gender or race, must be in good general health as determined by the
Investigator with a clinical diagnosis of common warts.

2. Subjects must have at least 1 visible, discrete, common wart with at least a 3 mm
longitudinal diameter on the hands, feet (excluding soles) and palms (in that order
of priority).

3. The warts must have been present for at least the past 12 weeks, but not more than 3
years

4. Subjects must agree to only use the study products and to not use any other
wart-removing product (prescription, OTC or occlusion) during the course of the
study.

5. Subjects must be free of any systemic or dermatologic disorder, which in the opinion
of the Investigator, will interfere with the study results.

6. Female subjects of childbearing potential must agree to use contraception during the
study. All women of childbearing potential must have a negative urine pregnancy test
at Screening and Baseline and at 4, 8 & 12 weeks visits.

7. Subjects are physically able to apply study product to all affected areas or can
obtain help.

Exclusion Criteria:

1. Women who are pregnant or nursing or planning to become pregnant during the study.

2. Subjects who have been treated for warts within the 30 days prior to the Baseline
Visit (e.g. salicylic acid, azelaic acid, cryotherapy).

3. Subjects who have participated in a trial involving any investigational product in
the 30 days prior to the Baseline Visit.

4. Subjects with chronic or active liver disease, renal impairment, cutaneous or
systemic lupus erythematosus, an autoimmune disorder, immunosuppression, or any other
disease or medical condition that would interfere with the study or place the subject
at unacceptable risk, as determined by the investigator.

5. Subjects on immunosuppressive agents that would impact their immune response e.g.
cyclosporine, mycophenolate mofetil, azathioprine, etc.

6. Subjects who use or have used local/systemic steroids or any other immunosuppressive
medication within the 30 days prior to the Baseline Visit.

7. Subjects who use or have used systemic or topical retinoids within the 30 days prior
to the Baseline Visit.

8. Subjects who are unable to comply with study requirements.

9. Subjects with other skin diseases like molluscum contagiosum that may confound the
evaluation of common warts.

10. Subjects who have received treatment for any type of cancer within 5 years of the
Baseline Visit, except skin cancer and cervical cancer (in situ) are allowed if at
least 1 year before the Baseline Visit.

11. Subjects unable to comply with study requirements
We found this trial at
12
sites
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Crowley, LA
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College Station, TX
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Colorado Springs, Colorado 80910
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Fridley, MN
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Hot Springs, Arkansas 71913
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Hot Springs, AR
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Johnston, RI
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Marietta, GA
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Sacramento, CA
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Tampa, FL
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