Plaque PsoriasisPhase 4NCT02749799
Patient Satisfaction Following Twice Daily Dosing With DFD-01 in Subjects With Moderate Plaque Psoriasis
A Phase 4 study testing DFD-01 (betamethasone dipropionate) Spray, 0.05% in people with Plaque Psoriasis, run by Primus Pharmaceuticals at 4 sites in United States.
Trial summary
The purpose of this study is to assess clinical response and patient satisfaction when DFD-01 is used topically twice a day for moderate plaque psoriasis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Plaque Psoriasis
- What is being tested?
- DFD-01 (betamethasone dipropionate) Spray, 0.05%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 4 sitesUnited States
- Study dates
- Feb 2016to Aug 2016
- Phase
- Phase 4
- 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
- Patient understands the study procedures and agrees to participate by giving written informed consent. Patients must be willing to authorize use and disclosure of protected health information collected for the study.
- Patient must be at least 18 years of age.
- Patient must present with a clinical diagnosis of stable (at least 3 months) plaque-type psoriasis.
- At least 3% Body Surface Area involved, not including the face, scalp, groin, axillae and other intertriginous areas.
- Female patients of childbearing potential must agree to use contraception during the study which can include abstinence with an adequate secondary option should the patient become sexually active. A female is considered of childbearing potential unless she is:
- Postmenopausal for at least 12 months prior to study product administration;
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- Without a uterus and/or both ovaries; or has been surgically sterile (i.e., tubal ligation) for at least 6 months prior to study product administration.
- Reliable methods of contraception are:
- Hormonal methods or intrauterine device in use > 90 days prior to study product administration; or
- Barrier methods plus spermicide in use at least 14 days prior to study product administration.
- Partner has had a vasectomy at least 3 months previous to study product administration.
- Essure® that has been in place for at least 3 months before the screening visit with radiograph confirmation of fallopian tube blockage.
- Exception: Sexually inactive female patients of childbearing potential are not required to practice a reliable method of contraception and may be enrolled at the Investigator's discretion provided that they are counseled to remain sexually inactive for the duration of the study and understand the possible risks involved in getting pregnant during the study. An abstinent female must agree that if she becomes sexually active during the study she will use an acceptable form of contraception.
- All women must complete a urine pregnancy test at the Baseline Visit (Day 1) and the test result must be negative to be eligible for enrollment.
- Patient 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 (temperature, blood pressure and pulse).
- Patient is physically able to apply study product to all affected areas or can obtain help.
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, pigmented lesions, tattoos or sunburn that 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.
- Ongoing infection (including viral lesions of the skin, fungal or bacterial skin infections, ulcers or wounds) or evidence of chronic infectious disease, history of or current system disorder, organ disorder or other medical condition that in the Investigator's opinion would place the study patient at undue risk by participation in the study.
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- Use within 180 days before Baseline Visit of biologic treatment for psoriasis (e.g., infliximab, adalimumab, etanercept, ustekinumab, secukinumab, 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) that are allowed if at least 1 year before the Baseline Visit.
- Use within 60 days before 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 before the Baseline Visit of: 1) systemic corticosteroids, 2) Ultraviolet light therapy, or 3) systemic anti-inflammatory agents* (e.g., mycophenolate mofetil, sulfasalazine, 6-thioguanine). * Over-the-counter strength non-steroidal anti-inflammatory drugs used for transitional and common aches are permitted during the study.
- Use within 14 days before 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.
- History of unresolved or current hypothalamic-pituitary-adrenal suppression or significant endocrine disorder (Cushing's disease or Addison's disease) or uncontrolled diabetes.
- Patients who have participated in a study of an investigational drug 30 days before the Baseline Visit.
- Patients unable to comply with study requirements.
- Female patients who are pregnant (or planning to become pregnant) or breast-feeding.
- History of drug or alcohol abuse within the last year.
- Planned use of a tanning bed during the study.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Site Four
Arlington Heights, Illinois, 60005
Site Three
Las Vegas, Nevada, 89129
Site One
Louisville, Kentucky, 40202
Site Two
New Albany, Indiana, 47150
About this study
Official title: An Open-Label, Multicenter Study of Patient-Reported Satisfaction Following Twice Daily Dosing With Betamethasone Dipropionate Spray, 0.05% in Subjects With Moderate Plaque Psoriasis
The purpose of this study is to assess clinical response and patient satisfaction when DFD-01 is used topically twice a day for moderate plaque psoriasis.
Read the detailed description
This multicenter, multi-dose, open-label study was designed to assess clinical response and patient-reported satisfaction after dosing with DFD-01 twice daily for 28 days. The product was approved for the treatment of mild to moderate plaque psoriasis by the FDA on February 5, 2016 before the first patient was enrolled.
Forty five (45) adult males and females, 18 years of age and older with a clinical diagnosis of moderate plaque psoriasis who met inclusion/exclusion criteria were randomized at the Baseline Visit. Each site attempted to enroll 50% of the patients with 3% to 10% body surface area (BSA) involved and 50% of the patients with > 10% BSA involved.
The initial dose of study product was self-administered by the patient and supervised by clinic staff during the Baseline Visit. Patients continued to apply the study product to all affected areas (avoiding the face, scalp, groin, axillae or other intertriginous areas) twice daily (approximately 12 hours apart) for 28 days. Patients visited the clinic for a total of up to five scheduled visits:
- Screening (Day -60 to 1)*
- Baseline (Day 1)
- Interim Visit (Day 8 ± 2)
- Interim Visit (Day 14 ± 3)
- End of Study (Day 29 ± 3)
- Conditions
- Plaque Psoriasis
- Being tested
- DFD-01 (betamethasone dipropionate) Spray, 0.05%
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DFD-01 (betamethasone dipropionate) Spray, 0.05%Drug
Also called Sernivo (betamethasone dipropionate, 0.05%) Spray
DFD-01 (betamethasone dipropionate) Spray, 0.05% to be applied twice daily on the affected areas (avoiding the face, scalp, groin, axillae and other intertriginous areas) for 28 days.
| Study group | Role | What they receive |
|---|---|---|
| DFD-01 (betamethasone dipropionate) Spray, 0.05% | Experimental | DFD-01 (betamethasone dipropionate) Spray, 0.05% to be applied twice daily on the affected areas (avoiding the face, scalp, groin, axillae and other intertriginous areas) for 28 days. Receives: Drug: DFD-01 (betamethasone dipropionate) Spray, 0.05% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Investigator's Global Assessment Grade
The mean change in the IGA score from baseline to Day 14 was assessed. IGA score is a static assessment of disease severity and is based on overall severity of signs at each visit. It's a 4-point scale where '0' is absent disease and '4' is 'Severe/Very Severe' disease. A lower score at the end of the study compared to baseline (negative change), indicates an improvement in the disease condition.
Measured: Change from Baseline to Day 14.
Change in Percent Body Surface Area (BSA) Involved.
Change in the BSA of involvement with psoriasis from baseline to Day 14 was assessed. BSA was assessed at Baseline, Days 8, 14 and 29.
Measured: Change from Baseline to Day 14.
Change in Dermatology Life Quality Index (DLQI)
DLQI is a simple, compact, and practical questionnaire to assess limitations related to the impact of skin disease. The instrument contains ten items dealing with the participant's skin. The participant responds on a four-point scale, ranging from "Very Much" (score 3) to "Not at All" or "Not relevant" (score 0). The DLQI total score is derived by summing all item scores, which has a possible range of 0 to 30, with 30 corresponding to the worst quality of life, and 0 corresponding to the best. A lower score (i.e., negative change score) indicates improvement in the Quality of Life.
Measured: Change from Baseline to Day 14.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2016 (estimated)
- Study startFeb 2016
- Primary completionJul 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 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Primus Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Prosoft Clinical
- Responsible party
- Sponsor
- Investigators
- Srinivas Sidgiddi, MD, Study director, Dr. Reddy's Laboratories Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02749799
- Sponsor's protocol ID
- DFD-01-CD-014
- Status last verified
- Mar 2024
- First submitted
- 13 Apr 2016
- Last updated
- 7 Mar 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
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
- An Open-Label, Multicenter Study of Patient-Reported Satisfaction Following Twice Daily Dosing With Betamethasone Dipropionate Spray, 0.05% in Subjects With Moderate Plaque Psoriasis
- ClinicalTrials.gov ID
- NCT02749799
- Acronym / sponsor ID
- DFD-01-CD-014
- Conditions
- Plaque Psoriasis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Primus PharmaceuticalsIndustry (pharma, biotech, devices)
- Collaborators
- Prosoft Clinical
- Study start
- Feb 2016
- Primary completion
- Jul 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 25 Apr 2016 (estimated)
- Results
- Posted 5 Oct 2020
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 assess clinical response and patient satisfaction when DFD-01 is used topically twice a day for moderate plaque psoriasis.
Detailed description
This multicenter, multi-dose, open-label study was designed to assess clinical response and patient-reported satisfaction after dosing with DFD-01 twice daily for 28 days. The product was approved for the treatment of mild to moderate plaque psoriasis by the FDA on February 5, 2016 before the first patient was enrolled.
Forty five (45) adult males and females, 18 years of age and older with a clinical diagnosis of moderate plaque psoriasis who met inclusion/exclusion criteria were randomized at the Baseline Visit. Each site attempted to enroll 50% of the patients with 3% to 10% body surface area (BSA) involved and 50% of the patients with > 10% BSA involved.
The initial dose of study product was self-administered by the patient and supervised by clinic staff during the Baseline Visit. Patients continued to apply the study product to all affected areas (avoiding the face, scalp, groin, axillae or other intertriginous areas) twice daily (approximately 12 hours apart) for 28 days. Patients visited the clinic for a total of up to five scheduled visits:
- Screening (Day -60 to 1)*
- Baseline (Day 1)
- Interim Visit (Day 8 ± 2)
- Interim Visit (Day 14 ± 3)
- End of Study (Day 29 ± 3)
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DFD-01 (betamethasone dipropionate) Spray, 0.05% | Experimental | Drug: DFD-01 (betamethasone dipropionate) Spray, 0.05%DFD-01 (betamethasone dipropionate) Spray, 0.05% to be applied twice daily on the affected areas (avoiding the face, scalp, groin, axillae and other intertriginous areas) 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 (16 listed)
- Patient understands the study procedures and agrees to participate by giving written informed consent. Patients must be willing to authorize use and disclosure of protected health information collected for the study.
- Patient must be at least 18 years of age.
- Patient must present with a clinical diagnosis of stable (at least 3 months) plaque-type psoriasis.
- At least 3% Body Surface Area involved, not including the face, scalp, groin, axillae and other intertriginous areas.
- Female patients of childbearing potential must agree to use contraception during the study which can include abstinence with an adequate secondary option should the patient become sexually active. A female is considered of childbearing potential unless she is:
Key exclusion criteria (17 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, pigmented lesions, tattoos or sunburn that 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 |
|---|---|---|
| DFD-01 (betamethasone dipropionate) Spray, 0.05%Also: Sernivo (betamethasone dipropionate, 0.05%) SprayDFD-01 (betamethasone dipropionate) Spray, 0.05% to be applied twice daily on the affected areas (avoiding the face, scalp, groin, axillae and other intertriginous areas) for 28 days. | Drug | DFD-01 (betamethasone dipropionate) Spray, 0.05% |
Primary outcome
Change in Investigator's Global Assessment Grade
Time frame: Change from Baseline to Day 14.
The mean change in the IGA score from baseline to Day 14 was assessed. IGA score is a static assessment of disease severity and is based on overall severity of signs at each visit. It's a 4-point scale where '0' is absent disease and '4' is 'Severe/Very Severe' disease. A lower score at the end of the study compared to baseline (negative change), indicates an improvement in the disease condition.
Change in Percent Body Surface Area (BSA) Involved.
Time frame: Change from Baseline to Day 14.
Change in the BSA of involvement with psoriasis from baseline to Day 14 was assessed. BSA was assessed at Baseline, Days 8, 14 and 29.
Change in Dermatology Life Quality Index (DLQI)
Time frame: Change from Baseline to Day 14.
DLQI is a simple, compact, and practical questionnaire to assess limitations related to the impact of skin disease. The instrument contains ten items dealing with the participant's skin. The participant responds on a four-point scale, ranging from "Very Much" (score 3) to "Not at All" or "Not relevant" (score 0). The DLQI total score is derived by summing all item scores, which has a possible range of 0 to 30, with 30 corresponding to the worst quality of life, and 0 corresponding to the best. A lower score (i.e., negative change score) indicates improvement in the Quality of Life.
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.
- 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.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing DFD-01 (betamethasone dipropionate) Spray, 0.05% in people with Plaque Psoriasis, run by Primus Pharmaceuticals at 4 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 16 inclusion and 17 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 4 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 5 Oct 2020). 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?
Change in Investigator's Global Assessment Grade (time frame: Change from Baseline to Day 14.). The study lists 3 primary outcomes in all. 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 7 Mar 2024; AzTrials last refreshed its copy on 6 Nov 2026.