Eight Week Study of Treatment With DFD-07 for Actinic Keratosis of the Face and Scalp

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02654717
Recruitment Status : Completed
First Posted : January 13, 2016
Last Update Posted : August 3, 2016
Information provided by (Responsible Party):
Promius Pharma, LLC

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.

Condition or disease Intervention/treatment Phase
Actinic Keratosis Drug: DFD-07 Cream Drug: Placebo Cream Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 111 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Study Start Date : November 2015
Actual Primary Completion Date : August 2016
Actual Study Completion Date : August 2016

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: DFD-07 cream
DFD-07 cream applied twice daily
Drug: DFD-07 Cream
Placebo Comparator: Placebo cream
Placebo cream applied twice daily
Drug: Placebo Cream

Primary Outcome Measures :
  1. Percent of patients with complete clearance of actinic keratosis (AK) lesions at end of treatment at 8 weeks [ Time Frame: 8 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02654717

Site One
Bochum, Germany, 44791
Site Two
Bonn, Germany, 53111
Site Three
Wuppertal, Germany, 42287
Sponsors and Collaborators
Promius Pharma, LLC

Responsible Party: Promius Pharma, LLC Identifier: NCT02654717     History of Changes
Other Study ID Numbers: DFD-07-CD-001
First Posted: January 13, 2016    Key Record Dates
Last Update Posted: August 3, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Keratosis, Actinic
Skin Diseases
Precancerous Conditions