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

Common Warts Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02798419
• Other study ID #: DFD05-CD-001
• Status: Completed
• Phase: Phase 2
• First received: June 9, 2016
• Last updated: August 15, 2016
• Start date: January 2016
• Est. completion date: August 2016

Study information

• Verified date: August 2016
• Source: Dr. Reddys Laboratories, SA
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

DFD05 vs. Active01 in the treatment of common warts

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: August 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Common Warts
• Warts

Intervention

Drug:
• DFD05 Cream

• Active01 Cream

Locations

Country	Name	City	State
United States	Investigational Site #3	Arlington Hts	Illinois
United States	Investigational Site #5	Austin	Texas
United States	Investigational Site #7	College Station	Texas
United States	Investigational Site #2	Colorado Springs	Colorado
United States	Investigational Site #10	Crowley	Louisiana
United States	Investigational Site #4	Fremont	California
United States	Investigational Site #8	Fridley	Minnesota
United States	Investigation Site #1	Hot Springs	Arkansas
United States	Investigational Site #6	Johnston	Rhode Island
United States	Investigational Site #9	Marietta	Georgia
United States	Investigational Site #11	Sacramento	California
United States	Investigational Site #12	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Dr. Reddys Laboratories, SA

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No