A Study to Evaluate Two Concentrations of DFD-07 Cream, in Subjects With Actinic Keratosis (AK) of the Face and/or Scalp Over a 12-week Treatment Period

A Multi-Center, Randomized, Double-Blind, Parallel-Group, Vehicle-Controlled Study to Evaluate the Dose-Response Relationship of the Efficacy and Safety of Two Concentrations of DFD-07 Cream, in Subjects With Actinic Keratosis (AK) of the Face and/or Scalp Over a 12-week Treatment Period.

Once or twice daily 12 week treatment in patients with Actinic Keratosis randomized to treatment in one of four arms.

Study Overview

• Status: Completed
• Conditions: Actinic Keratosis (AK)
• Intervention / Treatment: Drug: Low dose DFD07 once daily; Drug: High dose DFD07 once daily; Drug: High dose DFD07 twice daily; Drug: Placebo twice daily

• Study Type: Interventional
• Enrollment (Actual): 240
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• United States
  • California
    • Cerritos, California, United States, 90703
      • Investigator Site 3
    • Fremont, California, United States, 94538
      • Investigator Site 1
    • Palm Springs, California, United States, 92262
      • Investigator Site 9
    • Santa Ana, California, United States, 92701
      • Investigator Site 18
  • Florida
    • Boca Raton, Florida, United States, 33486
      • Investigator Site 16
    • Lake City, Florida, United States, 32055
      • Investigator Site 8
    • Miami, Florida, United States, 33126
      • Investigator Site 7
    • Miami, Florida, United States, 33162
      • Investigator Site 19
    • Miami Lakes, Florida, United States, 33016
      • Investigator Site 20
    • Ormond Beach, Florida, United States, 32174
      • Investigator Site 17
    • West Palm Beach, Florida, United States, 33409
      • Investigator Site 6
  • New Jersey
    • Verona, New Jersey, United States, 07044
      • Investigator Site 13
  • New York
    • Stony Brook, New York, United States, 11790
      • Investigator Site 15
  • Pennsylvania
    • Fort Washington, Pennsylvania, United States, 19034
      • Investigator Site 14
  • Texas
    • Austin, Texas, United States, 78660
      • Investigator Site 10
    • Houston, Texas, United States, 77055
      • Investigator Site 4
    • Plano, Texas, United States, 75024
      • Investigator Site 5
    • San Antonio, Texas, United States, 78229
      • Investigator Site 11
    • San Antonio, Texas, United States, 78229
      • Investigator Site 2
    • San Antonio, Texas, United States, 78249
      • Investigator Site 12

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion:

1. Subject understands the study procedures, is willing to comply with the study procedures and required visits, and agrees to participate by giving written informed consent. Subjects with a legal guardian, must have the written informed consent of the legal guardian.
2. Subject (or legal guardian) must be willing to authorize use and disclosure of protected health information collected for the study.
3. Subjects must have 5 or more AK lesions that are non-hypertrophic and non-hyperkeratotic, contained within a single contiguous approximately 5 cm x 5 cm (25 cm2) region of face and/or scalp.
4. Subjects must be 18 years of age or older. Male and female subjects can be enrolled.

5. Female subjects of childbearing potential must agree to use contraception during the study which can include abstinence with an adequate secondary option should the subject become sexually active. All women of childbearing potential must complete a urine pregnancy test at the Baseline Visit (Visit 2) and the test result must be negative to be eligible for enrollment.

   A female is considered of childbearing potential unless she is:

   1. postmenopausal for at least 12 months prior to study product administration;
   2. without a uterus and/or both ovaries; or has been surgically sterile (i.e., tubal ligation) for at least 6 months prior to study product administration.

   Reliable methods of contraception are:

   1. hormonal methods or intrauterine device in use more than 90 days prior to study product administration; or
   2. barrier methods plus spermicide in use at least 14 days prior to study product administration.
   3. partner has had a vasectomy at least 3 months previous to study product administration.
   4. Essure

   Exception: Sexually inactive female subjects of childbearing potential are not required to practice a reliable method of contraception and may be enrolled at the investigator's discretion provided that they are counseled to remain sexually inactive for the duration of the study and understand the possible risks involved in getting pregnant during the study. An abstinent female must agree that if she becomes sexually active during the study she will use an acceptable form of contraception.

6. Subjects must agree not to use any product on the treatment area during the entire course of study except for Investigator-approved cleanser, sunscreen, wash, and non-medicated make-up. Subjects should continue to use these Investigator-approved products for the duration of the study and should avoid any changes in these consumer products.
7. Subjects must be willing to comply with sun avoidance measures for the face including use of Investigator-approved sunscreen and/or hats, have limited sun exposure time, and have no tanning bed use.

8. Subjects must be in good general health as determined by the Investigator and supported by the medical history, and normal or not clinically significant abnormal vital signs (blood pressure and pulse rate). Subjects are eligible if:

   • Systolic blood pressure (BP) < 160 and > 85 mmHg
   • Diastolic BP < 100 and > 50 mmHg

Exclusion:

1. Known or suspected hypersensitivity to any non-steroidal anti-inflammatory drugs (NSAID) or any component of the formulation of the study medication, including a history of asthma, urticarial, or other allergic-type reactions after taking aspirin or other NSAIDs.
2. Known or suspected allergy to sulfonamides.
3. Clinical evidence of severe, uncontrolled autoimmune, cardiovascular, gastrointestinal, hematological, hepatic, neurologic, pulmonary or renal disease.
4. Recent (within 6 months) or planned coronary artery bypass graft surgery.
5. Significant history (within the past year) of alcohol or drug abuse.
6. Participation in any clinical research study within 30 days of the Baseline Visit.
7. Concomitant use of cosmetics or other topical drug products on or near the selected treatment area, except for Investigator-approved cleanser, sunscreen, wash, and non-medicated makeup.
8. Cosmetic or therapeutic procedures (e.g. laser, peeling, photodynamic therapy) within 2 weeks and within 2 cm of the selected treatment area.
9. Other skin conditions within the selected treatment area (e.g. rosacea, psoriasis, atopic dermatitis, eczema, basal or squamous cell carcinoma or albinism).
10. Any systemic cancer therapy or diagnosis within 6 months of the Baseline Visit.
11. Females who are pregnant or lactating or planning to become pregnant during the study period.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo twice daily	Drug: Placebo twice daily; Placebo twice daily
Experimental: Low dose DFD07 once daily	Drug: Low dose DFD07 once daily; Low dose DFD07 once daily
Experimental: High dose DFD07 once daily	Drug: High dose DFD07 once daily; High dose DFD07 once daily
Experimental: High dose DFD07 twice daily	Drug: High dose DFD07 twice daily; High dose DFD07 twice daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of Subjects With Complete Clearance of AK Lesions at the End of Study Visit at 16 Weeks	The proportion of subjects with complete clearance (absence of clinically visible or palpable AK lesions in the treatment area) of AK lesions at the End of Study Visit at 16 weeks (12 weeks treatment and 4 weeks treatment-free follow-up)	16 Weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of Subjects With Partial Clearance at Week 16	Proportion of subjects with partial clearance of AK lesions at week 16 (12 weeks treatment and 4 weeks treatment free follow up period)	16 weeks

Collaborators and Investigators

• Sponsor: Dr. Reddy's Laboratories Limited
• Investigators: Study Director: Srinivas R. Sidgiddi, M.D., Dr. Reddy's Laboratories

Study record dates

Study Major Dates

• Study Start (Actual): February 14, 2017
• Primary Completion (Actual): November 13, 2017
• Study Completion (Actual): July 5, 2018

Study Registration Dates

• First Submitted: April 12, 2017
• First Submitted That Met QC Criteria: April 14, 2017
• First Posted (Actual): April 17, 2017

Study Record Updates

• Last Update Posted (Actual): April 24, 2019
• Last Update Submitted That Met QC Criteria: April 2, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Precancerous Conditions; Keratosis, Actinic; Keratosis
• Other Study ID Numbers: DFD-07-CD-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No