Chronic Stable Plaque PsoriasisPhase 3NCT02445807

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 Chronic Stable Plaque Psoriasis, run by Promius Pharma, LLC at 30 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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: Chronic Stable Plaque Psoriasis
What is being tested?: DFD06-Cream
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 265 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).

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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.

City, postcode or hospital

30 sites in 1 country

United States30 sites

Site 104
Albuquerque, New Mexico, 87106
Site 119
Anderson, South Carolina, 29621
Site 108
Austin, Texas, 78759
Site 101
Birmingham, Alabama, 35205
Site 128
Clearwater, Florida, 33756
Site 112
Draper, Utah, 84020
Site 113
Fridley, Minnesota, 55432
Site 105
Glenn Dale, Maryland, 20769
Site 102
Greenville, South Carolina, 29607
Site 124
High Point, North Carolina, 27262
Site 122
Houston, Texas, 77030
Site 118
Indianapolis, Indiana, 46256
Site 129
Johnston, Rhode Island, 02919
Site 110
Louisville, Kentucky, 40202
Site 130
Mesa, Arizona, 85202
Site 115
Miami, Florida, 33144
Site 103
Mobile, Alabama, 36608
Site 106
Newington, New Hampshire, 03801
Site 120
North Hollywood, California, 91606
Site 116
Phoenix, Arizona, 85251
Site 107
Plano, Texas, 75024
Site 123
Saint Joseph, Missouri, 64506
Site 114
San Diego, California, 92117
Site 127
Santa Monica, California, 90404
Site 126
Spokane, Washington, 99202
Site 117
Stony Brook, New York, 11790
Site 125
Tucson, Arizona, 85712
Site 121
Walla Walla, Washington, 99362
Site 111
Warren, Michigan, 48088
Site 109
Winston-Salem, North Carolina, 27157

Other trials in United States

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: Chronic Stable Plaque Psoriasis
Being tested: DFD06-Cream, Vehicle Cream

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 groups in NCT02445807
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.

Efficacy (Percentage of Subjects With Treatment Success)
The primary efficacy endpoint is 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.
The primary analysis was done with multiple imputations. Results are combined analyses from 5 imputed data sets.
Measured: Day 15 Visit

Secondary outcomes (2)

The Percent Change in Body Surface Area of Psoriasis
The percent change from baseline in Body Surface Area at Day 15. The analysis was done with multiple imputations. Results are combined analyses from 5 imputed data sets.
Measured: From Baseline to Day 15
The Percentage of Subjects With Treatment Success at the Day 8 Visit.
The percentage of subjects with treatment success (defined as IGA = 0 or 1 and at least a 2 grade reduction from Baseline) at Day 8.
The analysis was done with multiple imputations. Results are combined analyses from 5 imputed data sets.
Measured: At Day 8 Visit

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2015Jul 2016

First posted15 May 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 Chronic Stable Plaque 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: 265 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02445807
Sponsor's protocol ID: DFD06-CD-005
Status last verified: Apr 2018
First submitted: 13 May 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: NCT02445807
Acronym / sponsor ID: DFD06-CD-005
Conditions: Chronic Stable Plaque Psoriasis
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 265 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: 15 May 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

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

Efficacy (Percentage of Subjects With Treatment Success)
Time frame: Day 15 Visit
The primary efficacy endpoint is 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. The primary analysis was done with multiple imputations. Results are combined analyses from 5 imputed data sets.

2 secondary outcomes

The Percent Change in Body Surface Area of Psoriasis
Time frame: From Baseline to Day 15
The Percentage of Subjects With Treatment Success at the Day 8 Visit.
Time frame: At Day 8 Visit

Results and safety

Results posted to the registry on 13 Apr 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
DFD-06 Cream	176	176
Vehicle Cream	89	89

Primary outcome: Efficacy (Percentage of Subjects With Treatment Success)

Time frame: Day 15 Visit. Number. Unit: percentage of participants

Measure	DFD-06 Cream n = 176	Vehicle Cream n = 89
Value	30.1	9.7

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: 6 Months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
DFD-06 Cream	1 of 176 (0.6%)	27 of 176 (15.3%)	0 of 176
Vehicle Cream	0 of 89 (0%)	26 of 89 (29.2%)	0 of 89

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

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 Chronic Stable Plaque 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?

Efficacy (Percentage of Subjects With Treatment Success) (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?

On the ClinicalTrials.gov record for NCT02445807.

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.