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

Primary Purpose

Actinic Keratosis

Status
Completed
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
DFD-07 Cream
Placebo Cream
Sponsored by
Promius Pharma, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Actinic Keratosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Site One
  • Site Two
  • Site Three

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

DFD-07 cream

Placebo cream

Arm Description

DFD-07 cream applied twice daily

Placebo cream applied twice daily

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Full Information

First Posted
December 24, 2015
Last Updated
March 5, 2020
Sponsor
Promius Pharma, LLC
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1. Study Identification

Unique Protocol Identification Number
NCT02654717
Brief Title
Eight Week Study of Treatment With DFD-07 for Actinic Keratosis of the Face and Scalp
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
November 2015 (undefined)
Primary Completion Date
August 2016 (Actual)
Study Completion Date
August 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Promius Pharma, LLC

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Actinic Keratosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
111 (Actual)

8. Arms, Groups, and Interventions

Arm Title
DFD-07 cream
Arm Type
Experimental
Arm Description
DFD-07 cream applied twice daily
Arm Title
Placebo cream
Arm Type
Placebo Comparator
Arm Description
Placebo cream applied twice daily
Intervention Type
Drug
Intervention Name(s)
DFD-07 Cream
Intervention Type
Drug
Intervention Name(s)
Placebo Cream
Primary Outcome Measure Information:
Title
Percent of Patients With Complete Clearance of Lesions
Description
Percent of patients with complete clearance of actinic keratosis (AK) lesions at the end of treatment (8 weeks)
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: To be eligible for the study, the patients have to fulfil all of the following criteria at Visit 1: Written informed consent has been signed and dated prior to any study related procedure or initiation of a wash out period Skin type I, II or III according to Fitzpatrick 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 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. 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: 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: Known or suspected hypersensitivity to any non-steroidal anti-inflammatory drug (NSAID) or a 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 sunscreens 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
Facility Information:
Facility Name
Site One
City
Bochum
ZIP/Postal Code
44791
Country
Germany
Facility Name
Site Two
City
Bonn
ZIP/Postal Code
53111
Country
Germany
Facility Name
Site Three
City
Wuppertal
ZIP/Postal Code
42287
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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