Actinic Keratosis (AK)
Conditions
Interventions
Product Name: DFD-07 (Celecoxib, Topical Cream, 1.25%)
Product Code: DFD-07
Pharmaceutical Form: Cream
INN or Proposed INN: Celecoxib
Other descriptive name: CELECOXIB
Concentration unit: % percent
Co
Sponsors
Promius Pharma LLC
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Written informed consent has been signed and dated prior to any study related procedure or the initiation of a wash-out period • Skin type I, II or III according to Fitzpatrick • 5-8 AK mild to moderate grade lesions in an approximately 25 cm2 region of scalp, forehead or face that are non-hypertrophic and non-hyperkeratotic • 18 years of age or older • 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 and be willing to be tested throughout the study. 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. • = 60 days washout from prohibited medications: o Masoprocol o 5-Fluorouracil o Cyclosporine o Retinoids o Trichloroacetic Acid/Lactic Acid Peel o 50% Glycolic Acid Peel o Topical or systemic diclofenac, celecoxib or any other NSAID (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 o Photodynamic therapy o 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 BCG Topical coal tar products Topical or systemic corticosteroids Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 30 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 80
Exclusion criteria
Exclusion criteria: • Known or suspected hypersensitivity to any NSAID or any component of the formulation of the study medication • Clinical evidence of severe, uncontrolled autoimmune, cardiovascular, gastrointestinal, hematological, hepatic, neurologic, pulmonary or renal disease. • Significant history (within the past year) of alcohol or drug abuse • Participation in any clinical research study within 60 days of the Baseline Visit. • Pregnancy, lactation or plans to become pregnant • Concomitant use of cosmetics or other topical drug products on or near the selected treatment area. However, the use of topical sun screens is allowed. • 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) • Use of sun lamps or tanning beds or booths during the 14 days prior to the Baseline Visit or planned use during the study • Any systemic cancer therapy within 6 months of the Baseline Visit
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate the efficacy of 1.25% DFD-07 after 8 weeks of self-application by the patient (1g of cream per day). The primary endpoint is the percent of patients with complete clearance of AK lesions at the End of Treatment Visit at 8 weeks (absence of clinically visible or palpable AK lesions in the treatment area). All lesions in the treatment area will be included in the count even if the lesion was a new lesion that was not identified at Baseline.;Secondary Objective: 1. Percent of patients with complete clearance of AK lesions at Week 4 for 1.25% DFD-07 compared to placebo 2. Percent of patients with complete clearance of AK lesions at the End of Study (EOS) Visit (8 weeks treatment plus 30-day follow up) for 1.25% DFD-07 compared to placebo 3. Percent of patients with partial clearance of AK lesions at Weeks 4, 8, and the EOS Visit defined as at least a 75% reduction in the number of AK lesions in the treatment area compared to Baseline for 1.25% DFD-07 compared to placebo 4. Percent change from baseline in AK lesion count at Weeks 4, 8 and the EOS Visit for 1.25% DFD-07 compared to placebo 5. Local skin reactions by dose strength (1.25% DFD-07 or placebo): a. Erythema b. Edema c. Weeping/Exudate d. Flaking/Scaling/Dryness e. Scabbing/Crusting f. Erosion/Ulceration g. Vesiculation/Blistering ;Primary end point(s): The primary endpoint is complete clearance of AK lesions at the End of Treatment Visit at 8 weeks (absence of clinically visible or palpable AK lesions in the treatment area).;Timepoint(s) of evaluation of this end point: After 8 weeks (End of treatment) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Partial clearance of AK lesions (at least 75% reduction in number of AK lesions) 2. Percent change in baseline from AK lesion counts 3. Local skin reaction;Timepoint(s) of evaluation of this end point: End of study (8 weeks + 30 days) | — |
Countries
Germany
Contacts
Public ContactManaging Director
Flexopharm GmbH & Co. KG
Outcome results
None listed