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

DFD05 vs. Active01 in the treatment of common warts

Study Overview

• Status: Completed
• Conditions: Common Warts
• Intervention / Treatment: Drug: DFD05 Cream; Drug: Active01 Cream

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Arkansas
    • Hot Springs, Arkansas, United States, 71913
      • Investigation Site #1
  • California
    • Fremont, California, United States, 94538
      • Investigational Site #4
    • Sacramento, California, United States, 95821
      • Investigational Site #11
  • Colorado
    • Colorado Springs, Colorado, United States, 80904
      • Investigational Site #2
  • Florida
    • Tampa, Florida, United States, 33609
      • Investigational Site #12
  • Georgia
    • Marietta, Georgia, United States, 30060
      • Investigational Site #9
  • Illinois
    • Arlington Hts, Illinois, United States, 60005
      • Investigational Site #3
  • Louisiana
    • Crowley, Louisiana, United States, 70526
      • Investigational Site #10
  • Minnesota
    • Fridley, Minnesota, United States, 55432
      • Investigational Site #8
  • Rhode Island
    • Johnston, Rhode Island, United States, 02919
      • Investigational Site #6
  • Texas
    • Austin, Texas, United States, 78759
      • Investigational Site #5
    • College Station, Texas, United States, 77845
      • Investigational Site #7

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: DFD05 Cream	Drug: DFD05 Cream
ACTIVE_COMPARATOR: Active01 Cream	Drug: Active01 Cream

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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)

Collaborators and Investigators

• Sponsor: Dr. Reddys Laboratories, SA

Study record dates

Study Major Dates

• Study Start: January 1, 2016
• Primary Completion (ACTUAL): May 1, 2016
• Study Completion (ACTUAL): August 1, 2016

Study Registration Dates

• First Submitted: June 9, 2016
• First Submitted That Met QC Criteria: June 13, 2016
• First Posted (ESTIMATE): June 14, 2016

Study Record Updates

• Last Update Posted (ESTIMATE): August 16, 2016
• Last Update Submitted That Met QC Criteria: August 15, 2016
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Virus Diseases; Infections; DNA Virus Infections; Skin Diseases, Infectious; Papillomavirus Infections; Skin Diseases, Viral; Tumor Virus Infections; Warts
• Other Study ID Numbers: DFD05-CD-001