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

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

Official Title
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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.

Conditions
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Actinic Keratosis (AK)

Intervention / Treatment
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* Drug: Low dose DFD07 once daily
* Drug: High dose DFD07 once daily
* Drug: High dose DFD07 twice daily
* Drug: Placebo twice daily


Participation Criteria
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Eligibility Criteria
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Inclusion: 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. 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. 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: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Low dose DFD07 once daily<br> | Drug: Low dose DFD07 once daily<br>* Low dose DFD07 once daily<br>|
| Experimental: High dose DFD07 once daily<br> | Drug: High dose DFD07 once daily<br>* High dose DFD07 once daily<br>|
| Experimental: High dose DFD07 twice daily<br> | Drug: High dose DFD07 twice daily<br>* High dose DFD07 twice daily<br>|
| Placebo Comparator: Placebo twice daily<br> | Drug: Placebo twice daily<br>* Placebo twice daily<br>|

What is the study measuring?
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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 |