PsoriasisPhase 3NCT01967069

A Comparison of DFD01 Spray Versus Vehicle Spray in Subjects With Moderate Psoriasis

A Phase 3 study testing DFD01 Spray in people with Psoriasis, run by Primus Pharmaceuticals at 28 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

The objectives of this study are to compare the efficacy and safety of DFD01 Spray to Vehicle Spray for topical treatment of moderate plaque psoriasis Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Psoriasis
What is being tested?: DFD01 Spray
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 277 participants
Where: 28 sitesUnited States
Study dates: Nov 2013to Jul 2014
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

Subjects must present with a clinical diagnosis of stable (at least 3 months) plaque-type psoriasis.
Subjects with psoriasis involving 10 to 20% BSA, not including the face, scalp, groin, axillae and other intertriginous areas.
Subjects must have an IGA grade of 3 (moderate) at the Baseline Visit

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 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, or alefacept).
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 within 1 year of the Baseline Visit.
Use within 60 days prior to the Baseline Visit of: 1) immunosuppressive drugs (e.g., tacrolimus, pimecrolimus), 2) systemic antipsoriatic treatment (e.g., methotrexate, cyclosporine, hydroxyurea) or 3) oral retinoids (e.g., acitretin, isotretinoin).

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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.
Require use of beta blockers, lithium, ACE inhibitors, and/or NSAIDs (indomethacin, ibuprofen, aspirin, naproxen) with a medical history that these medications affect the subject's psoriasis, except if the subject has been using the medication routinely during the 180 days prior to the Baseline Visit, these medications are allowed.

Trial locations and contacts

28 sites in 1 country.

City, postcode or hospital

28 sites in 1 country

United States28 sites

Augusta Centre for Dermatology and Skin Renewal, LLC
Augusta, Georgia, 30909
Skin Care Research, Inc.
Boca Raton, Florida, 33486
MOORE Clinical Research, Inc.
Brandon, Florida, 33511
Charlottesville Medical Research Center, LLC
Charlottesville, Virginia, 22911
Radiant Research, Inc.
Cincinnati, Ohio, 45249
MLFKnuckles, MD, PSC
Corbin, Kentucky, 40701
Horizons Clinical Research Center, LLC
Denver, Colorado, 80220
Henry Ford Medical Center, New Center One
Detroit, Michigan, 48202
Hamzavi Dermatology
Fort Gratiot, Michigan, 48059
Bettencourt Skin Center
Henderson, Nevada, 89074
Center for Clinical Studies, LTD, LLP
Houston, Texas, 77004
Shondra L. Smith, MD Dermatology & Advanced Aesthetics
Lake Charles, Louisiana, 70605
FXM Research Corop.
Miami, Florida, 33175
Coastal Clinical Research, Inc.
Mobile, Alabama, 36608
Dr. Tory P. Sullivan, MD, PA
North Miami Beach, Florida, 33162
Dermatology Specialists, Inc.
Oceanside, California, 92056
Skin Specialists P.C.
Omaha, Nebraska, 68144
Paddington Testing Company, Inc.
Philadelphia, Pennsylvania, 19103
Skin Search of Rochester, Inc.
Rochester, New York, 14623
Dermatology Clinical Research Center of San Antonio
San Antonio, Texas, 78229
Progressive Clinical Reesearch, PA
San Antonio, Texas, 78229
University Clinical Trials, Inc
San Diego, California, 92123
Clinical Science Institute
Santa Monica, California, 90404
Gwinnett Clinical Research Center, Inc.
Snellville, Georgia, 30078
Hudson Dermatology/Clinical Research Advantage
Tempe, Arizona, 85282
Eastern Washington Dermatology
Walla Walla, Washington, 99362
Grekin Skin Institute
Warren, Michigan, 48088
Brodell Medical, Inc.
Warren, Ohio, 44483

Other trials in United States

About this study

The objectives of this study are to compare the efficacy and safety of DFD01 Spray to Vehicle Spray for topical treatment of moderate plaque psoriasis

Conditions: Psoriasis
Being tested: DFD01 Spray, Vehicle Spray
Medical subject headings: Psoriasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

DFD01 SprayDrug
Vehicle SprayDrug

Study groups in NCT01967069
Study group	Role	What they receive
DFD01 Spray	Active comparator	DFD01 Spray twice daily Receives: Drug: DFD01 Spray
Vehicle Spray	Placebo comparator	Vehicle Spray twice daily Receives: Drug: Vehicle Spray

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of Participants With Treatment Success According to the Investigator's Global Assessment (IGA)
IGA of clear or almost clear
Measured: Day 15

Timeline

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

Nov 2013Jul 2014

First posted22 Oct 2013 (estimated)
Study startNov 2013
Primary completionJul 2014
Study completionJul 2014

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: Double blind
Who is masked: Participant, Investigator
Enrolment: 277 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01967069
Sponsor's protocol ID: 1206
Status last verified: Mar 2024
First submitted: 17 Oct 2013
Last updated: 7 Mar 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingPhase 2
Extension Study of Safety and Tolerability of DDY391 in Participants With Moderate to Severe Psoriatic Arthritis (CDDY391A12201-extension)
Moderate to Severe Psoriatic Arthritis
Recruiting
Efficacy of a Self-Management Smartphone App to Improve Safety Skills in Patients With Inflammatory Arthritis
Rhumatoid Arthisis, Spondyloarthritis (SA)
Active, not recruitingPhase 2
Dose Ranging Study of ORKA-001 in Patients With Moderate-to-Severe Plaque Psoriasis
Plaque Psoriasis
RecruitingPhase 1
A Study of HB0017 Injection in Healthy Volunteers to Evaluate Safety and Tolerability of a Single Subcutaneous Injection in Low-Body-Weight Subjects; and Pharmacokinetics at Different Subcutaneous Injection Sites at the Same Dose
Psoriasis, Ankylosing Spondylitis
RecruitingPhase 1
A Study to Learn if Bimekizumab Given in Different Ways is Safe and Moves Similarly Throughout the Body Over Time in Adults
Psoriatic Arthritis, Axial Spondyloarthritis

All Psoriasis trials

Study at a glance

From the registry record, last updated by the sponsor on 7 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Comparison of DFD01 Spray Versus Vehicle Spray in Subjects With Moderate Psoriasis
ClinicalTrials.gov ID: NCT01967069
Acronym / sponsor ID: 1206
Conditions: Psoriasis
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 277 participants (actual)
Lead sponsor: Primus PharmaceuticalsIndustry (pharma, biotech, devices)
Collaborators: Prosoft Clinical
Study start: Nov 2013
Primary completion: Jul 2014 (actual)
Study completion: Jul 2014 (actual)
First posted: 22 Oct 2013 (estimated)
Results: Posted 13 Mar 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The objectives of this study are to compare the efficacy and safety of DFD01 Spray to Vehicle Spray for topical treatment of moderate plaque psoriasis

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
DFD01 Spray	Active comparator	Drug: DFD01 SprayDFD01 Spray twice daily
Vehicle Spray	Placebo comparator	Drug: Vehicle SprayVehicle Spray twice daily

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Subjects must present with a clinical diagnosis of stable (at least 3 months) plaque-type psoriasis.
Subjects with psoriasis involving 10 to 20% BSA, not including the face, scalp, groin, axillae and other intertriginous areas.
Subjects must have an IGA grade of 3 (moderate) at the Baseline Visit

Key exclusion criteria (9 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 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, or alefacept).
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 within 1 year 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
DFD01 Spray	Drug	DFD01 Spray
Vehicle Spray	Drug	Vehicle Spray

Primary outcome

Percentage of Participants With Treatment Success According to the Investigator's Global Assessment (IGA)
Time frame: Day 15
IGA of clear or almost clear

Results and safety

Results posted to the registry on 13 Mar 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
DFD01 Spray	182	174
Vehicle Spray	95	87

Primary outcome: Percentage of Participants With Treatment Success According to the Investigator's Global Assessment (IGA)

Time frame: Day 15. Number (95% Confidence Interval). Unit: percentage of subjects

Measure	DFD01 Spray n = 182	Vehicle Spray n = 95
Value	21.50 (15.5 to 27.5)	7.4 (2.1 to 12.7)

Population analysed: Intent to Treat

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
DFD01 Spray	1 of 179 (0.6%)	17 of 179 (9.5%)	Not reported
Vehicle Spray	2 of 93 (2.2%)	24 of 93 (25.8%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Psoriasis

Not yet recruitingPhase 2
Extension Study of Safety and Tolerability of DDY391 in Participants With Moderate to Severe Psoriatic Arthritis (CDDY391A12201-extension)
Moderate to Severe Psoriatic Arthritis
Recruiting
Efficacy of a Self-Management Smartphone App to Improve Safety Skills in Patients With Inflammatory Arthritis
Rhumatoid Arthisis, Spondyloarthritis (SA)
Active, not recruitingPhase 2
Dose Ranging Study of ORKA-001 in Patients With Moderate-to-Severe Plaque Psoriasis
Plaque Psoriasis
RecruitingPhase 1
A Study of HB0017 Injection in Healthy Volunteers to Evaluate Safety and Tolerability of a Single Subcutaneous Injection in Low-Body-Weight Subjects; and Pharmacokinetics at Different Subcutaneous Injection Sites at the Same Dose
Psoriasis, Ankylosing Spondylitis
RecruitingPhase 1
A Study to Learn if Bimekizumab Given in Different Ways is Safe and Moves Similarly Throughout the Body Over Time in Adults
Psoriatic Arthritis, Axial Spondyloarthritis

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.

28 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 DFD01 Spray in people with Psoriasis, run by Primus Pharmaceuticals at 28 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 3 inclusion and 9 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 7 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 28 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 Mar 2017). 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 Participants With Treatment Success According to the Investigator's Global Assessment (IGA) (time frame: Day 15). 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 NCT01967069.

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 7 Mar 2024.