Clinical trial NCT02654717: Eight Week Study of Treatment With DFD-07 for Actinic Keratosis of the Face and Scalp
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Actinic Keratosis
Lead sponsor: Promius Pharma, LLC
Sponsor class: INDUSTRY
First posted: 2016-01-13
Enrollment: 111
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to see how well DFD-07 works in treating actinic keratosis on the face and scalp during 8 weeks of treatment. The study will also look at any unwanted effects of the study drug.


Eligibility criteria: Inclusion Criteria:

To be eligible for the study, the patients have to fulfil all of the following criteria at Visit 1:

1. Written informed consent has been signed and dated prior to any study related procedure or initiation of a wash out period
2. Skin type I, II or III according to Fitzpatrick
3. 5-8 Actinic Keratosis (AK) mild to moderate grade lesions in an approximately 25 cm2 region of scalp, forehead or face that are non-hypertrophic and non-hyperkeratotic
4. 18 years of age or older
5. Female patients of childbearing potential must agree to use contraception during the study which can include abstinence with a secondary contraceptive option should the patient become sexually active. All women of childbearing potential must have a negative urine pregnancy test (test must have a sensitivity of at least 25 IU/ML for human chorionic gonadotropin) at the Baseline Visit. A female is considered of childbearing potential unless she is pre-menarche, postmenopausal with no menses for at least 12 months or surgically sterile. Reliable methods of contraception are hormonal methods or intrauterine devices in use for at least 90 days prior to the Baseline Visit or barrier methods plus spermicide use for at least 14 days prior to the Baseline Visit or a partner who has had a vasectomy at least 3 months prior to the Baseline Visit.
6. ≥ 60 days washout from prohibited medications:

   * Masoprocol
   * 5-Fluorouracil
   * Cyclosporine
   * Retinoids
   * Trichloroacetic Acid/Lactic Acid Peel
   * 50% Glycolic Acid Peel
   * Topical or systemic diclofenac, celecoxib or any other non-sterioda anti-inflammatory drug (however daily low-dose aspirin is allowed, as long as the patient has been on a stable dose, ≤ 100 mg once a day, for 60 days prior to the start of the study.) Note: Patients may use acetaminophen/paracetamol as needed
   * Photodynamic therapy
   * Topical or systemic immunomodulating agents including:

     * Systemic, topical or intralesional interferon
     * Imiquimod (Aldara, Zyclara)
     * Topical ingenol mebutate (Picato)
     * Topical tacrolimus
     * Topical pimecrolimus
     * Sirolimus
     * Cyclosporin
     * Intralesional Bacillus Calmette-Guerin (BCG)
     * Topical coal tar products
     * Topical or systemic corticosteroids

Exclusion Criteria:

Patients who fulfil one or more of the following criteria, will not be eligible for the study:

1. Known or suspected hypersensitivity to any non-steroidal anti-inflammatory drug (NSAID) or a component of the formulation of the study medication
2. Clinical evidence of severe, uncontrolled autoimmune, cardiovascular, gastrointestinal, hematological, hepatic, neurologic, pulmonary or renal disease.
3. Significant history (within the past year) of alcohol or drug abuse
4. Participation in any clinical research study within 60 days of the Baseline Visit.
5. Pregnancy, lactation or plans to become pregnant
6. Concomitant use of cosmetics or other topical drug products on or near the selected treatment area. However, the use of topical sunscreens is allowed.
7. Cosmetic or therapeutic procedures (e.g. laser, peeling, photodynamic therapy) within 2 weeks and within 2 cm of the selected treatment area.
8. Other skin conditions within the selected treatment area (e.g. rosacea, psoriasis, atopic dermatitis, eczema, basal or squamous cell carcinoma or albinism)
9. Use of sun lamps or tanning beds or booths during the 14 days prior to the Baseline Visit or planned use during the study.
10. Any systemic cancer therapy within 6 months of the Baseline Visit

Primary outcomes:
measure: Percent of Patients With Complete Clearance of Lesions
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Bochum
country: Germany
facility: Site One
city: Bonn
country: Germany
facility: Site Two
city: Wuppertal
country: Germany
facility: Site Three
Study officials:
References: