Common WartsPhase 2NCT02798419
Active-Controlled Study to Assess the Efficacy and Safety of DFD-05 in Subjects With Common Warts
A Phase 2 study testing DFD05 Cream and Active01 Cream in people with Common Warts, run by Dr. Reddys Laboratories, SA at 12 sites in United States.
Trial summary
DFD05 vs. Active01 in the treatment of common warts Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Common Warts
- What is being tested?
- DFD05 Cream and Active01 Cream
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 12 sitesUnited States
- Study dates
- Jan 2016to Aug 2016
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 11Show fewer
- 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
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
Investigational Site #3
Arlington Hts, Illinois, 60005
Investigational Site #5
Austin, Texas, 78759
Investigational Site #7
College Station, Texas, 77845
Investigational Site #2
Colorado Springs, Colorado, 80904
Investigational Site #10
Crowley, Louisiana, 70526
Investigational Site #4
Fremont, California, 94538
Investigational Site #8
Fridley, Minnesota, 55432
Investigation Site #1
Hot Springs, Arkansas, 71913
Investigational Site #6
Johnston, Rhode Island, 02919
Investigational Site #9
Marietta, Georgia, 30060
Investigational Site #11
Sacramento, California, 95821
Investigational Site #12
Tampa, Florida, 33609
About this study
DFD05 vs. Active01 in the treatment of common warts
- Conditions
- Common Warts
- Being tested
- DFD05 Cream, Active01 Cream
- Medical subject headings
- Warts
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DFD05 CreamDrug
Active01 CreamDrug
| Study group | Role | What they receive |
|---|---|---|
| DFD05 Cream | Experimental | DFD05 Cream Receives: Drug: DFD05 Cream |
| Active01 Cream | Active comparator | Active01 Cream Receives: Drug: Active01 Cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of subjects categorized as treatment responders (defined as having at least 91% reduction in surface area, averaged across all target warts)
Measured: Visit 5 (week 12)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2016 (estimated)
- Study startJan 2016
- Primary completionMay 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Common WartsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Reddys Laboratories, SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02798419
- Sponsor's protocol ID
- DFD05-CD-001
- Status last verified
- Aug 2016
- First submitted
- 9 Jun 2016
- Last updated
- 16 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Active-Controlled Study to Assess the Efficacy and Safety of DFD-05 in Subjects With Common Warts
- ClinicalTrials.gov ID
- NCT02798419
- Acronym / sponsor ID
- DFD05-CD-001
- Conditions
- Common Warts
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Dr. Reddys Laboratories, SAIndustry (pharma, biotech, devices)
- Study start
- Jan 2016
- Primary completion
- May 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 14 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
DFD05 vs. Active01 in the treatment of common warts
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DFD05 Cream | Experimental | Drug: DFD05 CreamDFD05 Cream |
| Active01 Cream | Active comparator | Drug: Active01 CreamActive01 Cream |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DFD05 Cream | Drug | DFD05 Cream |
| Active01 Cream | Drug | Active01 Cream |
Primary outcome
The proportion of subjects categorized as treatment responders (defined as having at least 91% reduction in surface area, averaged across all target warts)
Time frame: Visit 5 (week 12)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing DFD05 Cream and Active01 Cream in people with Common Warts, run by Dr. Reddys Laboratories, SA at 12 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of subjects categorized as treatment responders (defined as having at least 91% reduction in surface area, averaged across all target warts) (time frame: Visit 5 (week 12)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2016.