PsoriasisPhase 3NCT02635204
A Study of the Efficacy and Safety of DFD-06 Cream in the Treatment of Moderate to Severe Plaque Psoriasis
A Phase 3 study testing DFD06 Cream in people with Psoriasis, run by Promius Pharma, LLC at 30 sites in United States.
Trial summary
This study will compare the efficacy and safety of DFD-06 Cream to Vehicle Cream for topical treatment of moderate to severe plaque psoriasis after 3, 7, and 14 days of treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psoriasis
- What is being tested?
- DFD06 Cream
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 267 participants
- Where
- 30 sitesUnited States
- Study dates
- Dec 2015to Jul 2016
- Phase
- Phase 3
- 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
- Subject understands the study procedures and agrees to participate by giving written informed consent. Subjects must be willing to authorize use and disclosure of protected health information collected for the study.
- Subject must be at least 18 years of age.
- Subject must present with a clinical diagnosis of stable (at least 3 months) plaque-type psoriasis.
- Subject with psoriasis involving 3% or greater BSA, not including the face, scalp, groin, axillae and other intertriginous areas.
- Subject must have an IGA grade of 3 or 4 (moderate to severe) at the Baseline Visit.
- Female subjects of childbearing potential must agree to use contraception during the study which can include abstinence with an adequate secondary option should the subject become sexually active. All women of childbearing potential must complete a urine pregnancy test (test must have a sensitivity of at least 25mIU/ml for human chorionic gonadotropin) at the Baseline Visit (Visit 2) and the test result must be negative to be eligible for enrollment.
- Subject must be in good general health as determined by the investigator and supported by the medical history and normal or not clinically significant abnormal vital signs (blood pressure and pulse).
Who cannot join
- Current diagnosis of unstable forms of psoriasis including guttate, erythrodermic, exfoliative or pustular psoriasis.
- Other inflammatory skin disease that may confound the evaluation of the plaque psoriasis (e.g., atopic dermatitis, contact dermatitis, tinea corporis).
- Presence of pigmentation, extensive scarring, or pigmented lesions or sunburn which could interfere with the rating of efficacy parameters.
- History of psoriasis unresponsive to biological or topical treatments.
- History of organ transplant requiring immunosuppression, HIV, or other immunocompromised state.
- Use within 180 days prior to Baseline Visit of biologic treatment for psoriasis (e.g., infliximab, adalimumab, etanercept, ustekinumab, secukinumab, or alefacept).
Show all 11Show fewer
- Have received treatment for any type of cancer within 5 years of the Baseline Visit except skin cancer and cervical cancer (in situ) are allowed if at least 1 year before the Baseline Visit.
- Use within 60 days prior to the Baseline Visit of: 1) systemic or topical immunosuppressive drugs (e.g., tacrolimus, pimecrolimus), 2) systemic antipsoriatic treatment (e.g., methotrexate, cyclosporine, hydroxyurea) or 3) oral retinoids (e.g., acitretin, isotretinoin).
- Use within 30 days prior to the Baseline Visit of: 1) systemic steroids, 2) PUVA therapy, 3) systemic anti-inflammatory agents (e.g., mycophenolate mofetil, sulfasalazine, 6-thioguanine), or 4) UVB therapy. Inhaled, intraocular, and intranasal steroids are allowed.
- Use within 14 days prior to the Baseline Visit of: 1) topical antipsoriatic drugs (e.g., salicylic acid, anthralin, coal tar, calcipotriene), 2) topical retinoids (e.g., tazarotene, tretinoin) or 3) topical corticosteroids.
- Subjects who have participated in a study of an investigational drug 60 days prior to the Baseline Visit.
Trial locations and contacts
30 sites in 1 country.
30 sites in 1 country
United States30 sites
128
Arlington, Texas, 76014
Site 103
Arlington Heights, Illinois, 60005
Site 127
Beverly, Massachusetts, 01915
Site 108
Brandon, Florida, 33511
Site 126
Cincinnati, Ohio, 45255
Site 112
Coral Gables, Florida, 33134
Site 101
Dallas, Texas, 75234
Site 113
Denver, Colorado, 80220
Site 124
Fountain Valley, California, 92708
Site 116
Glendale, Arizona, 85308
129
Henderson, Nevada, 89052
Site 102
Houston, Texas, 77056
Site 106
Jacksonville, Florida, 32204
Site 120
Laguna Hills, California, 92653
Site 107
Nashville, Tennessee, 37215
Site 117
New Haven, Connecticut, 06511
Site 114
New York, New York, 10019
Site 118
Norfolk, Virginia, 23507
Site 115
Overland Park, Kansas, 66215
Site 110
Pinellas Park, Florida, 33781
Site 119
Quincy, Massachusetts, 02169
Site 125
Richmond, Virginia, 23294
Site 104
Rocky Mount, North Carolina, 27804
Site 111
Rogers, Arkansas, 72758
Site 109
San Antonio, Texas, 78229
Site 122
San Diego, California, 92108
Site 123
San Diego, California, 92123
Site 121
Warwick, Rhode Island, 02886
130
West Palm Beach, Florida, 33406
Site 105
Wilmington, North Carolina, 28401
About this study
Official title: A Randomized, Double-Blind, Vehicle-Controlled, Multicenter, Parallel Group Study of the Efficacy and Safety of DFD-06 Cream in the Treatment of Moderate to Severe Plaque Psoriasis for 14 Days
This study will compare the efficacy and safety of DFD-06 Cream to Vehicle Cream for topical treatment of moderate to severe plaque psoriasis after 3, 7, and 14 days of treatment.
Read the detailed description
This study will be a multicenter (approximately 30 sites), randomized, vehicle-controlled, double-blind, and parallel group design. Approximately 264 subjects with moderate to severe plaque psoriasis will be randomized to treatment with DFD-06 Cream or Vehicle Cream. Subjects will use study product twice daily for 14 days. Subject visits are scheduled at Screening, Baseline (Day 1) and Days 4, 8, and 15. Clinical determinations of disease severity will be performed using the total sign score (TSS) for the target lesion and Investigator Global Assessment (IGA) for overall severity.
- Conditions
- Psoriasis
- Being tested
- DFD06 Cream, Vehicle Cream
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DFD06 CreamDrug
Also called Clobetasol propionate Cream, 0.025%
Twice daily topical application for 14 days.
Vehicle CreamDrug
Twice daily topical application for 14 days.
| Study group | Role | What they receive |
|---|---|---|
| DFD-06 Cream | Experimental | DFD-06 Cream will be applied to subjects with moderate plaque psoriasis twice daily for 14 days. Receives: Drug: DFD06 Cream |
| Vehicle Cream | Placebo comparator | Vehicle Cream will be applied to subjects with moderate plaque psoriasis twice daily for 14 days. Receives: Drug: Vehicle Cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Subjects With Treatment Success at Day 15
The percentage of subjects with treatment success (defined as IGA = 0 or 1 and at least a 2-grade reduction from baseline) at the Day 15 visit. Primary analysis was done with multiple imputations. Results are combined analyses from 5 imputed data sets.
Measured: Day 15 Visit
Secondary outcomes (2)
Percent Change From Baseline in Body Surface Area at Day 15
Percent change from baseline in body surface area affected by psoriasis at Day 15. The analysis was done with multiple imputations. Results are combined analyses from 5 imputed data sets.
Measured: Baseline and Day 15
Percent of Subjects With Treatment Success at Day 8 Visit
Percent of subjects with treatment success at Day 8 Visit defined as an IGA of 0 or 1 with at least a 2 grade reduction from baseline. The analysis was done with multiple imputations. Results are combined analyses from 5 imputed data sets.
Measured: Baseline and Day 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2015 (estimated)
- Study startDec 2015
- Primary completionJul 2016
- Study completionJul 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 PsoriasisStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 267 participants (actual)
Sponsor and investigators
- Lead sponsor
- Promius Pharma, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Srinivas Sidgiddi, MD, Study director, Dr. Reddy's Laboratories, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02635204
- Sponsor's protocol ID
- DFD06-CD-004
- Status last verified
- Apr 2018
- First submitted
- 8 Dec 2015
- Last updated
- 15 May 2018
- 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 15 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Vehicle-Controlled, Multicenter, Parallel Group Study of the Efficacy and Safety of DFD-06 Cream in the Treatment of Moderate to Severe Plaque Psoriasis for 14 Days
- ClinicalTrials.gov ID
- NCT02635204
- Acronym / sponsor ID
- DFD06-CD-004
- Conditions
- Psoriasis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 267 participants (actual)
- Lead sponsor
- Promius Pharma, LLCIndustry (pharma, biotech, devices)
- Study start
- Dec 2015
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 18 Dec 2015 (estimated)
- Results
- Posted 13 Apr 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will compare the efficacy and safety of DFD-06 Cream to Vehicle Cream for topical treatment of moderate to severe plaque psoriasis after 3, 7, and 14 days of treatment.
Detailed description
This study will be a multicenter (approximately 30 sites), randomized, vehicle-controlled, double-blind, and parallel group design. Approximately 264 subjects with moderate to severe plaque psoriasis will be randomized to treatment with DFD-06 Cream or Vehicle Cream. Subjects will use study product twice daily for 14 days. Subject visits are scheduled at Screening, Baseline (Day 1) and Days 4, 8, and 15. Clinical determinations of disease severity will be performed using the total sign score (TSS) for the target lesion and Investigator Global Assessment (IGA) for overall severity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DFD-06 Cream | Experimental | Drug: DFD06 CreamDFD-06 Cream will be applied to subjects with moderate plaque psoriasis twice daily for 14 days. |
| Vehicle Cream | Placebo comparator | Drug: Vehicle CreamVehicle Cream will be applied to subjects with moderate plaque psoriasis twice daily for 14 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Subject understands the study procedures and agrees to participate by giving written informed consent. Subjects must be willing to authorize use and disclosure of protected health information collected for the study.
- Subject must be at least 18 years of age.
- Subject must present with a clinical diagnosis of stable (at least 3 months) plaque-type psoriasis.
- Subject with psoriasis involving 3% or greater BSA, not including the face, scalp, groin, axillae and other intertriginous areas.
- Subject must have an IGA grade of 3 or 4 (moderate to severe) at the Baseline Visit.
Key exclusion criteria (11 listed)
- Current diagnosis of unstable forms of psoriasis including guttate, erythrodermic, exfoliative or pustular psoriasis.
- Other inflammatory skin disease that may confound the evaluation of the plaque psoriasis (e.g., atopic dermatitis, contact dermatitis, tinea corporis).
- Presence of pigmentation, extensive scarring, or pigmented lesions or sunburn which could interfere with the rating of efficacy parameters.
- History of psoriasis unresponsive to biological or topical treatments.
- History of organ transplant requiring immunosuppression, HIV, or other immunocompromised state.
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 |
|---|---|---|
| DFD06 CreamAlso: Clobetasol propionate Cream, 0.025%Twice daily topical application for 14 days. | Drug | DFD-06 Cream |
| Vehicle CreamTwice daily topical application for 14 days. | Drug | Vehicle Cream |
Primary outcome
Percentage of Subjects With Treatment Success at Day 15
Time frame: Day 15 Visit
The percentage of subjects with treatment success (defined as IGA = 0 or 1 and at least a 2-grade reduction from baseline) at the Day 15 visit. Primary analysis was done with multiple imputations. Results are combined analyses from 5 imputed data sets.
2 secondary outcomes
Percent Change From Baseline in Body Surface Area at Day 15
Time frame: Baseline and Day 15
Percent of Subjects With Treatment Success at Day 8 Visit
Time frame: Baseline and Day 8
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Srinivas Sidgiddi, MD study director
Dr. Reddy's Laboratories, Inc
30 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing DFD06 Cream in people with Psoriasis, run by Promius Pharma, LLC at 30 sites in United States.
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 7 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 15 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 30 sites in United States. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 13 Apr 2018). 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?
Percentage of Subjects With Treatment Success at Day 15 (time frame: Day 15 Visit). 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 15 May 2018.