PsoriasisPhase 3NCT01947491
A Comparison of DFD01 Spray Versus Comp01 Lotion, Vehicle Spray and Vehicle Lotion in Subjects With Moderate Psoriasis
A Phase 3 study testing DFD01 Spray and Comp01 Lotion in people with Psoriasis, run by Primus Pharmaceuticals at 40 sites in United States.
Trial summary
The objectives of this study are to compare the safety of DFD01 Spray to Comp01 Lotion for topical treatment of moderate plaque psoriasis and to compare the efficacy of DFD01 Spray to Placebo Spray for topical treatment of moderate plaque psoriasis after 28 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?
- DFD01 Spray and Comp01 Lotion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 394 participants
- Where
- 40 sitesUnited States
- Study dates
- Nov 2013to Jan 2015
- 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.
Trial locations and contacts
40 sites in 1 country.
40 sites in 1 country
United States40 sites
Academic Dermatology Associates
Albuquerque, New Mexico, 87106
David Fivenson, MD, PLC
Ann Arbor, Michigan, 48103
DermResearch, Inc.
Austin, Texas, 78759
J & S Studies, Inc.
College Station, Texas, 77845
Cherry Creek Research, Inc.
Denver, Colorado, 80209
Colorado Medical Research Center Inc.
Denver, Colorado, 80210
Psoriasis Treatment Center of Central NJ
East Windsor, New Jersey, 08520
California Dermatology and Clinical Research Institute
Encinitas, California, 92024
Encino Research Center
Encino, California, 91436
Center for Dematology Clinical Research, Inc.
Fremont, California, 94538
Rivergate Dermatology Clinical Research Center, PLLC
Goodlettsville, Tennessee, 37072
Carolina Dermatology of Greenville, PA
Greenville, South Carolina, 29607
Zoe Diane Draelos, MD, PA
High Point, North Carolina, 27262
Burke Pharmaceutical Research
Hot Springs, Arkansas, 71913
The Center for Skin Research
Houston, Texas, 77056
Dermatology Specialists Research
Louisville, Kentucky, 40202
The Education & Research Foundation, Inc.
Lynchburg, Virginia, 24501
Florida Academic Center Research and Education
Miami, Florida, 33136
International Dermatology Research Inc.
Miami, Florida, 33144
Horizon Research Group, Inc.
Mobile, Alabama, 36608
Coastal Carolina Research Center
Mt. Pleasant, South Carolina, 29464
Tennessee Clinical Research Center
Nashville, Tennessee, 37215
The Savin Center, PC
New Haven, Connecticut, 06511
Fran Cook-Bolden, MD
New York, New York, 10155
Virginia Clinical Research, Inc.
Norfolk, Virginia, 23507
Compliant Clinical Research Inc.
Olathe, Kansas, 66061
Quality Clinical Research, Inc.
Omaha, Nebraska, 68114
The Indiana Clinical Trials Center
Plainfield, Indiana, 46168
Wake Research Associates, LLC
Raleigh, North Carolina, 27612
Lawrence J. Green, MD, LLC
Rockville, Maryland, 20850
Dermatology Research Center, Inc.
Salt Lake City, Utah, 84117
Stephen Miller, MD, PA
San Antonio, Texas, 78249
Skin Surgery Medical Group, Inc.
San Diego, California, 92117
Redwood Dermatology Research
Santa Rosa, California, 95403
South Bend Clinic, LLP
South Bend, Indiana, 46617
Haber Dermatology & Cosmetic Surgery, Inc.
South Euclid, Ohio, 44118
Premier Clinical Research
Spokane, Washington, 99204
DermResearch Center of New York Stony Brook Medical Park
Stony Brook, New York, 11790
Center for Clinical Studies
Webster, Texas, 77598
PMG Research of Winston-Salem
Winston-Salem, North Carolina, 27101
About this study
The objectives of this study are to compare the safety of DFD01 Spray to Comp01 Lotion for topical treatment of moderate plaque psoriasis and to compare the efficacy of DFD01 Spray to Placebo Spray for topical treatment of moderate plaque psoriasis after 28 days of treatment.
- Conditions
- Psoriasis
- Being tested
- DFD01 Spray, Comp01 Lotion, Vehicle Lotion, 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
Also called Topical corticosteroid spray
Comp01 LotionDrug
Also called Topical corticosteroid lotion
Vehicle LotionDrug
Vehicle SprayDrug
| Study group | Role | What they receive |
|---|---|---|
| DFD01 Spray | Experimental | DFD01 Spray twice daily for 28 days Receives: Drug: DFD01 Spray |
| Vehicle Spray | Placebo comparator | Vehicle Spray twice daily for 28 days Receives: Drug: Vehicle Spray |
| Comp01 Lotion | Active comparator | Comp01 Lotion twice daily for 14 days Receives: Drug: Comp01 Lotion |
| Vehicle Lotion | Placebo comparator | Vehicle Lotion twice daily for 28 days Receives: Drug: Vehicle Lotion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Success According to the Investigator 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.
- First posted20 Sep 2013 (estimated)
- Study startNov 2013
- Primary completionJan 2015
- Study completionJan 2015
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.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 394 participants (actual)
Sponsor and investigators
- Lead sponsor
- Primus Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Prosoft Clinical
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01947491
- Sponsor's protocol ID
- 1205
- Status last verified
- Mar 2024
- First submitted
- 17 Sep 2013
- Last updated
- 7 Mar 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Sidgiddi S, Pakunlu RI, Allenby K. Efficacy, Safety, and Potency of Betamethasone Dipropionate Spray 0.05%: A Treatment for Adults with Mild-to-moderate Plaque Psoriasis. J Clin Aesthet Dermatol. 2018 Apr;11(4):14-22. Epub 2018 Apr 1.
PubMed 29657667
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 Comp01 Lotion, Vehicle Spray and Vehicle Lotion in Subjects With Moderate Psoriasis
- ClinicalTrials.gov ID
- NCT01947491
- Acronym / sponsor ID
- 1205
- Conditions
- Psoriasis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 394 participants (actual)
- Lead sponsor
- Primus PharmaceuticalsIndustry (pharma, biotech, devices)
- Collaborators
- Prosoft Clinical
- Study start
- Nov 2013
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 20 Sep 2013 (estimated)
- Results
- Posted 6 Oct 2016
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 safety of DFD01 Spray to Comp01 Lotion for topical treatment of moderate plaque psoriasis and to compare the efficacy of DFD01 Spray to Placebo Spray for topical treatment of moderate plaque psoriasis after 28 days of treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| DFD01 Spray | Experimental | Drug: DFD01 SprayDFD01 Spray twice daily for 28 days |
| Vehicle Spray | Placebo comparator | Drug: Vehicle SprayVehicle Spray twice daily for 28 days |
| Comp01 Lotion | Active comparator | Drug: Comp01 LotionComp01 Lotion twice daily for 14 days |
| Vehicle Lotion | Placebo comparator | Drug: Vehicle LotionVehicle Lotion twice daily for 28 days |
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 (5 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.
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 SprayAlso: Topical corticosteroid spray | Drug | DFD01 Spray |
| Comp01 LotionAlso: Topical corticosteroid lotion | Drug | Comp01 Lotion |
| Vehicle Lotion | Drug | Vehicle Lotion |
| Vehicle Spray | Drug | Vehicle Spray |
Primary outcome
Percentage of Participants With Success According to the Investigator Global Assessment (IGA)
Time frame: Day 15
IGA of clear or almost clear
Results and safety
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.
- Derived from this study: PubMed 29657667Sidgiddi S, Pakunlu RI, Allenby K. Efficacy, Safety, and Potency of Betamethasone Dipropionate Spray 0.05%: A Treatment for Adults with Mild-to-moderate Plaque Psoriasis. J Clin Aesthet Dermatol. 2018 Apr;11(4):14-22. Epub 2018 Apr 1.
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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.
The record lists no contact. Use the official record to reach the sponsor.
40 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 and Comp01 Lotion in people with Psoriasis, run by Primus Pharmaceuticals at 40 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 5 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 40 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 6 Oct 2016). 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 Success According to the Investigator 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 NCT01947491, which also lists 1 linked publication.
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.