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

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.

Study Overview

• Status: Completed
• Conditions: Actinic Keratosis
• Intervention / Treatment: Drug: DFD-07 Cream; Drug: Placebo Cream

• Study Type: Interventional
• Enrollment (Actual): 111
• Phase: Phase 2

Contacts and Locations

Study Locations

• Germany
  • Bochum, Germany, 44791
    • Site One
  • Bonn, Germany, 53111
    • Site Two
  • Wuppertal, Germany, 42287
    • Site Three

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent of Patients With Complete Clearance of Lesions	Percent of patients with complete clearance of actinic keratosis (AK) lesions at the end of treatment (8 weeks)	8 weeks

Collaborators and Investigators

• Sponsor: Promius Pharma, LLC

Study record dates

Study Major Dates

• Study Start: November 1, 2015
• Primary Completion (Actual): August 1, 2016
• Study Completion (Actual): August 1, 2016

Study Registration Dates

• First Submitted: December 24, 2015
• First Submitted That Met QC Criteria: January 12, 2016
• First Posted (Estimate): January 13, 2016

Study Record Updates

• Last Update Posted (Actual): March 17, 2020
• Last Update Submitted That Met QC Criteria: March 5, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Precancerous Conditions; Keratosis, Actinic; Keratosis
• Other Study ID Numbers: DFD-07-CD-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No