Actinic Keratosis
Conditions
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.
Interventions
DRUGDFD-07 Cream
DRUGPlacebo Cream
Sponsors
Promius Pharma, LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent of Patients With Complete Clearance of Lesions | 8 weeks | Percent of patients with complete clearance of actinic keratosis (AK) lesions at the end of treatment (8 weeks) |
Countries
Germany
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| DFD-07 Cream DFD-07 cream applied twice daily
DFD-07 Cream | 56 |
| Placebo Cream Placebo cream applied twice daily
Placebo Cream | 55 |
| Total | 111 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 2 | 2 |
| Overall Study | Non-permitted medication | 3 | 0 |
| Overall Study | Protocol Violation | 1 | 2 |
| Overall Study | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | DFD-07 Cream | Placebo Cream | Total |
|---|---|---|---|
| Age, Continuous | 72.0 Years STANDARD_DEVIATION 9.27 | 72.7 Years STANDARD_DEVIATION 6.89 | 72.4 Years STANDARD_DEVIATION 8.15 |
| Number of Actinic Keratosis lesions | 6.1 Number of lesions STANDARD_DEVIATION 1.2 | 6.1 Number of lesions STANDARD_DEVIATION 0.99 | 6.1 Number of lesions STANDARD_DEVIATION 1.09 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment Germany | 56 participants | 55 participants | 111 participants |
| Sex: Female, Male Female | 3 Participants | 6 Participants | 9 Participants |
| Sex: Female, Male Male | 53 Participants | 49 Participants | 102 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 56 | 0 / 55 |
| other Total, other adverse events | 3 / 56 | 7 / 55 |
| serious Total, serious adverse events | 1 / 56 | 3 / 55 |
Outcome results
Primary
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)
Time frame: 8 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| DFD-07 | Percent of Patients With Complete Clearance of Lesions | 4 Participants |
| Vehicle | Percent of Patients With Complete Clearance of Lesions | 4 Participants |