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

NCT03116698 | Completed Phase 2 Results FDA Drug

• 1 other identifier: DFD-07-CD-002
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 20

Brief Summary

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

Conditions

Actinic Keratosis (AK)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Proportion of Subjects With Partial Clearance at Week 16

  16 weeks

Study Arms (4)

Low dose DFD07 once daily

EXPERIMENTAL

Drug: Low dose DFD07 once daily

High dose DFD07 once daily

EXPERIMENTAL

Drug: High dose DFD07 once daily

High dose DFD07 twice daily

EXPERIMENTAL

Drug: High dose DFD07 twice daily

Placebo twice daily

PLACEBO COMPARATOR

Drug: Placebo twice daily

Interventions

Low dose DFD07 once daily DRUG

Low dose DFD07 once daily

Low dose DFD07 once daily

High dose DFD07 once daily DRUG

High dose DFD07 once daily

High dose DFD07 once daily

High dose DFD07 twice daily DRUG

High dose DFD07 twice daily

High dose DFD07 twice daily

Placebo twice daily DRUG

Placebo twice daily

Placebo twice daily

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Subject (or legal guardian) must be willing to authorize use and disclosure of protected health information collected for the study.
• 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.
• Subjects must be 18 years of age or older. Male and female subjects can be enrolled.
• 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:
• postmenopausal for at least 12 months prior to study product administration;
• 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:
• hormonal methods or intrauterine device in use more than 90 days prior to study product administration; or
• barrier methods plus spermicide in use at least 14 days prior to study product administration.
• partner has had a vasectomy at least 3 months previous to study product administration.
• 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.
• 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.

You may not qualify if:

• 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.
• Known or suspected allergy to sulfonamides.
• Clinical evidence of severe, uncontrolled autoimmune, cardiovascular, gastrointestinal, hematological, hepatic, neurologic, pulmonary or renal disease.
• Recent (within 6 months) or planned coronary artery bypass graft surgery.
• Significant history (within the past year) of alcohol or drug abuse.
• Participation in any clinical research study within 30 days of the Baseline Visit.
• 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.
• Cosmetic or therapeutic procedures (e.g. laser, peeling, photodynamic therapy) within 2 weeks and within 2 cm of the selected treatment area.
• Other skin conditions within the selected treatment area (e.g. rosacea, psoriasis, atopic dermatitis, eczema, basal or squamous cell carcinoma or albinism).
• Any systemic cancer therapy or diagnosis within 6 months of the Baseline Visit.
• Females who are pregnant or lactating or planning to become pregnant during the study period.

Sponsors & Collaborators

• Dr. Reddy's Laboratories Limited: lead

Study Sites (20)

Investigator Site 3

Cerritos, California, 90703, United States

Location

Investigator Site 1

Fremont, California, 94538, United States

Location

Investigator Site 9

Palm Springs, California, 92262, United States

Location

Investigator Site 18

Santa Ana, California, 92701, United States

Location

Investigator Site 16

Boca Raton, Florida, 33486, United States

Location

Investigator Site 8

Lake City, Florida, 32055, United States

Location

Investigator Site 7

Miami, Florida, 33126, United States

Location

Investigator Site 19

Miami, Florida, 33162, United States

Location

Investigator Site 20

Miami Lakes, Florida, 33016, United States

Location

Investigator Site 17

Ormond Beach, Florida, 32174, United States

Location

Investigator Site 6

West Palm Beach, Florida, 33409, United States

Location

Investigator Site 13

Verona, New Jersey, 07044, United States

Location

Investigator Site 15

Stony Brook, New York, 11790, United States

Location

Investigator Site 14

Fort Washington, Pennsylvania, 19034, United States

Location

Investigator Site 10

Austin, Texas, 78660, United States

Location

Investigator Site 4

Houston, Texas, 77055, United States

Location

Investigator Site 5

Plano, Texas, 75024, United States

Location

Investigator Site 11

San Antonio, Texas, 78229, United States

Location

Investigator Site 2

San Antonio, Texas, 78229, United States

Location

Investigator Site 12

San Antonio, Texas, 78249, United States

Location

MeSH Terms

Conditions

Keratosis, Actinic

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Keratosis; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Dr. Srinivas Sidgiddi
• Organization: Dr. Reddy's Laboratories Inc.

srinivassidgiddi@drreddys.com

6093759910

Study Officials

• Srinivas R. Sidgiddi, M.D.

  Dr. Reddy's Laboratories

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

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: April 12, 2017
• First Posted: April 17, 2017
• Study Start: February 14, 2017
• Primary Completion: November 13, 2017
• Study Completion: July 5, 2018
• Last Updated: April 24, 2019
• Results First Posted: April 24, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (20)