Active-Controlled Study to Assess the Efficacy and Safety of DFD-05 in Subjects With Common Warts
1 other identifier
interventional
50
1 country
12
Brief Summary
DFD05 vs. Active01 in the treatment of common warts
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Jan 2016
Shorter than P25 for phase_2
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2016
CompletedFirst Submitted
Initial submission to the registry
June 9, 2016
CompletedFirst Posted
Study publicly available on registry
June 14, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2016
CompletedAugust 16, 2016
August 1, 2016
4 months
June 9, 2016
August 15, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
The proportion of subjects categorized as treatment responders (defined as having at least 91% reduction in surface area, averaged across all target warts)
Visit 5 (week 12)
Study Arms (2)
DFD05 Cream
EXPERIMENTALDFD05 Cream
Active01 Cream
ACTIVE COMPARATORActive01 Cream
Interventions
Eligibility Criteria
You may qualify if:
- Subjects, any gender or race, must be in good general health as determined by the Investigator with a clinical diagnosis of common warts.
- 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).
- The warts must have been present for at least the past 12 weeks, but not more than 3 years
- 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.
- Subjects must be free of any systemic or dermatologic disorder, which in the opinion of the Investigator, will interfere with the study results.
- 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.
- Subjects are physically able to apply study product to all affected areas or can obtain help.
You may not qualify if:
- Women who are pregnant or nursing or planning to become pregnant during the study.
- Subjects who have been treated for warts within the 30 days prior to the Baseline Visit (e.g. salicylic acid, azelaic acid, cryotherapy).
- Subjects who have participated in a trial involving any investigational product in the 30 days prior to the Baseline Visit.
- 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.
- Subjects on immunosuppressive agents that would impact their immune response e.g. cyclosporine, mycophenolate mofetil, azathioprine, etc.
- Subjects who use or have used local/systemic steroids or any other immunosuppressive medication within the 30 days prior to the Baseline Visit.
- Subjects who use or have used systemic or topical retinoids within the 30 days prior to the Baseline Visit.
- Subjects who are unable to comply with study requirements.
- Subjects with other skin diseases like molluscum contagiosum that may confound the evaluation of common warts.
- 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.
- Subjects unable to comply with study requirements
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (12)
Investigation Site #1
Hot Springs, Arkansas, 71913, United States
Investigational Site #4
Fremont, California, 94538, United States
Investigational Site #11
Sacramento, California, 95821, United States
Investigational Site #2
Colorado Springs, Colorado, 80904, United States
Investigational Site #12
Tampa, Florida, 33609, United States
Investigational Site #9
Marietta, Georgia, 30060, United States
Investigational Site #3
Arlington Hts, Illinois, 60005, United States
Investigational Site #10
Crowley, Louisiana, 70526, United States
Investigational Site #8
Fridley, Minnesota, 55432, United States
Investigational Site #6
Johnston, Rhode Island, 02919, United States
Investigational Site #5
Austin, Texas, 78759, United States
Investigational Site #7
College Station, Texas, 77845, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 9, 2016
First Posted
June 14, 2016
Study Start
January 1, 2016
Primary Completion
May 1, 2016
Study Completion
August 1, 2016
Last Updated
August 16, 2016
Record last verified: 2016-08