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

• Sponsor: Promius Pharma, LLC (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02654717
• Collaborator: (none)
• Enrollment: 111
• Locations: 3
• Arms: 2
• Duration (Months): 9
• Patients Per Site: 37
• Patients Per Site Per Month: 4.1

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Actinic Keratosis	Drug: DFD-07 Cream; Drug: Placebo Cream	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 111 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Study Start Date: Nov 1, 2015
• Actual Primary Completion Date: Aug 1, 2016
• Actual Study Completion Date: Aug 1, 2016

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Site One	Bochum		Germany	44791
2	Site Two	Bonn		Germany	53111
3	Site Three	Wuppertal		Germany	42287

Sponsors and Collaborators

• Promius Pharma, LLC

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Promius Pharma, LLC
• ClinicalTrials.gov Identifier: NCT02654717
• Other Study ID Numbers: DFD-07-CD-001
• First Posted: Jan 13, 2016
• Last Update Posted: Mar 17, 2020
• Last Verified: Mar 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Keratosis, Actinic; Keratosis

Study Results

Participant Flow

Arm/Group Title	DFD-07 Cream	Placebo Cream
Arm/Group Description	DFD-07 cream applied twice daily DFD-07 Cream	Placebo cream applied twice daily Placebo Cream
Period Title: Overall Study
STARTED	56	55
COMPLETED	50	50
NOT COMPLETED	6	5

Baseline Characteristics

Arm/Group Title	DFD-07 Cream	Placebo Cream	Total
Arm/Group Description	DFD-07 cream applied twice daily DFD-07 Cream	Placebo cream applied twice daily Placebo Cream	Total of all reporting groups
Overall Participants	56	55	111
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	72.0 (9.27)	72.7 (6.89)	72.4 (8.15)
Sex: Female, Male (Count of Participants)
Female	3 5.4%	6 10.9%	9 8.1%
Male	53 94.6%	49 89.1%	102 91.9%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%
Region of Enrollment (participants) [Number]
Germany	56 100%	55 100%	111 100%
Number of Actinic Keratosis lesions (Number of lesions) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Number of lesions]	6.1 (1.2)	6.1 (0.99)	6.1 (1.09)

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	DFD-07	Vehicle
Arm/Group Description	Patients treated with DFD07 for 8 weeks	Pts treated with vehicle for 8 weeks
Measure Participants	52	51
Count of Participants [Participants]	4 7.1%	4 7.3%

Adverse Events

Time Frame	Adverse events were collected from Baseline visit until 30 days after the last treatment.
Arm/Group Title	DFD-07 Cream		Placebo Cream
Arm/Group Description	DFD-07 cream applied twice daily DFD-07 Cream		Placebo cream applied twice daily Placebo Cream
All Cause Mortality
	DFD-07 Cream		Placebo Cream
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/56 (0%)		0/55 (0%)
Serious Adverse Events
	DFD-07 Cream		Placebo Cream
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/56 (1.8%)		3/55 (5.5%)
Blood and lymphatic system disorders
B-cell lymphoma	0/56 (0%)	0	1/55 (1.8%)	1
Cardiac disorders
Cardiovascular Event	0/56 (0%)	0	1/55 (1.8%)	1
Musculoskeletal and connective tissue disorders
Compression fracture of lumbar vertebral body	1/56 (1.8%)	1	0/55 (0%)	0
Knee replacement	0/56 (0%)	0	1/55 (1.8%)	1
Other (Not Including Serious) Adverse Events
	DFD-07 Cream		Placebo Cream
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3/56 (5.4%)		7/55 (12.7%)
Infections and infestations
Nasopharyngitis	3/56 (5.4%)	3	7/55 (12.7%)	7

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.