Actinic KeratosisPhase 2NCT02654717
Eight Week Study of Treatment With DFD-07 for Actinic Keratosis of the Face and Scalp
A Phase 2 study testing DFD-07 Cream in people with Actinic Keratosis, run by Promius Pharma, LLC at 3 sites in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Actinic Keratosis
- What is being tested?
- DFD-07 Cream
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 111 participants
- Where
- 3 sitesGermany
- Study dates
- Nov 2015to Aug 2016
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 26Show fewer
- ≥ 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
3 sites in 1 country.
Germany3 sites
Site One
Bochum, 44791
Site Two
Bonn, 53111
Site Three
Wuppertal, 42287
About this study
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.
- Conditions
- Actinic Keratosis
- Being tested
- DFD-07 Cream, Placebo Cream
- Medical subject headings
- Keratosis, Actinic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DFD-07 CreamDrug
Placebo CreamDrug
| Study group | Role | What they receive |
|---|---|---|
| DFD-07 cream | Experimental | DFD-07 cream applied twice daily Receives: Drug: DFD-07 Cream |
| Placebo cream | Placebo comparator | Placebo cream applied twice daily Receives: Drug: Placebo Cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2016 (estimated)
- Study startNov 2015
- Primary completionAug 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Actinic KeratosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 111 participants (actual)
Sponsor and investigators
- Lead sponsor
- Promius Pharma, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02654717
- Sponsor's protocol ID
- DFD-07-CD-001
- Status last verified
- Mar 2020
- First submitted
- 24 Dec 2015
- Last updated
- 17 Mar 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Eight Week Study of Treatment With DFD-07 for Actinic Keratosis of the Face and Scalp
- ClinicalTrials.gov ID
- NCT02654717
- Acronym / sponsor ID
- DFD-07-CD-001
- Conditions
- Actinic Keratosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 111 participants (actual)
- Lead sponsor
- Promius Pharma, LLCIndustry (pharma, biotech, devices)
- Study start
- Nov 2015
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 13 Jan 2016 (estimated)
- Results
- Posted 18 Feb 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DFD-07 cream | Experimental | Drug: DFD-07 CreamDFD-07 cream applied twice daily |
| Placebo cream | Placebo comparator | Drug: Placebo CreamPlacebo cream applied twice daily |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (26 listed)
- 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
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DFD-07 Cream | Drug | DFD-07 cream |
| Placebo Cream | Drug | Placebo cream |
Primary outcome
Percent of Patients With Complete Clearance of Lesions
Time frame: 8 weeks
Percent of patients with complete clearance of actinic keratosis (AK) lesions at the end of treatment (8 weeks)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Actinic Keratosis
Active, not recruitingPhase 1
A Study of the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of BCX17725
Netherton Syndrome
RecruitingPhase 3
Study of Reformulated Levulan Kerastick Plus PDT for Actinic Keratosis on Upper Extremities
Actinic Keratosis
RecruitingPhase 3
Study of Reformulated Levulan Kerastick Plus PDT for Actinic Keratosis on Face and Scalp
Actinic Keratosis
Active, not recruitingPhase 3
A Pilot Clinical Trial Comparing Topical Fluorouracil to Fluorouracil Plus Calcipotriene Field Treatments in Patients With Multiple Actinic Keratoses
Multiple Actinic Keratoses
RecruitingPhase 3
Basal Cell Carcinoma Chemoprevention Trial
Basal Cell Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing DFD-07 Cream in people with Actinic Keratosis, run by Promius Pharma, LLC at 3 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 26 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Feb 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent of Patients With Complete Clearance of Lesions (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2020.