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
NCT ID: NCT03116698
Last Updated: 2019-04-24
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2/PHASE3
240 participants
INTERVENTIONAL
2017-02-14
2018-07-05
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Low dose DFD07 once daily
Low dose DFD07 once daily
Low dose DFD07 once daily
High dose DFD07 once daily
High dose DFD07 once daily
High dose DFD07 once daily
High dose DFD07 twice daily
High dose DFD07 twice daily
High dose DFD07 twice daily
Placebo twice daily
Placebo twice daily
Placebo twice daily
Interventions
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Low dose DFD07 once daily
Low dose DFD07 once daily
High dose DFD07 once daily
High dose DFD07 once daily
High dose DFD07 twice daily
High dose DFD07 twice daily
Placebo twice daily
Placebo twice daily
Eligibility Criteria
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Inclusion Criteria
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.
18 Years
65 Years
ALL
No
Sponsors
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Dr. Reddy's Laboratories Limited
INDUSTRY
Responsible Party
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Principal Investigators
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Srinivas R. Sidgiddi, M.D.
Role: STUDY_DIRECTOR
Dr. Reddy's Laboratories
Locations
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Investigator Site 3
Cerritos, California, United States
Investigator Site 1
Fremont, California, United States
Investigator Site 9
Palm Springs, California, United States
Investigator Site 18
Santa Ana, California, United States
Investigator Site 16
Boca Raton, Florida, United States
Investigator Site 8
Lake City, Florida, United States
Investigator Site 7
Miami, Florida, United States
Investigator Site 19
Miami, Florida, United States
Investigator Site 20
Miami Lakes, Florida, United States
Investigator Site 17
Ormond Beach, Florida, United States
Investigator Site 6
West Palm Beach, Florida, United States
Investigator Site 13
Verona, New Jersey, United States
Investigator Site 15
Stony Brook, New York, United States
Investigator Site 14
Fort Washington, Pennsylvania, United States
Investigator Site 10
Austin, Texas, United States
Investigator Site 4
Houston, Texas, United States
Investigator Site 5
Plano, Texas, United States
Investigator Site 11
San Antonio, Texas, United States
Investigator Site 2
San Antonio, Texas, United States
Investigator Site 12
San Antonio, Texas, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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DFD-07-CD-002
Identifier Type: -
Identifier Source: org_study_id
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