Plaque PsoriasisPhase 3NCT02527421
DFD01 Spray HPA Axis Suppression Study in Adolescent Patients With Moderate to Severe Plaque Psoriasis
A Phase 3 study testing DFD01 Spray in people with Plaque Psoriasis, run by Primus Pharmaceuticals at 8 sites in United States.
Trial summary
To evaluate the potential of DFD-01 (betamethasone dipropionate) Spray, 0.05% to suppress the hypothalamic-pituitary-adrenal (HPA) axis. Read more about this study
- Who is it for?
- Ages 12 to 16 years
- Conditions the study is for
- Plaque Psoriasis
- What is being tested?
- DFD01 Spray
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 8 sitesUnited States
- Study dates
- 19 Aug 2015to 30 Mar 2019
- 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 12 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Subjects must weigh at least 55 pounds
- Subjects must present with a clinical diagnosis of stable (at least 3 months) plaque psoriasis.
- Subjects with psoriasis involving ≥ 10% BSA, not including the face, scalp, groin, axillae and other intertriginous areas..
- Subjects must have moderate to severe plaque psoriasis at the Baseline Visit.
- Subjects whose results from the screening ACTH stimulation test are considered normal (cortisol level >18 ug/dL at 30 minutes post stimulation) and show no other signs of abnormal HPA axis function or adrenal response.
Who cannot join
- Current diagnosis of unstable forms of psoriasis including guttate, erythrodermic, exfoliative or pustular psoriasis.
- History of organ transplant requiring immunosuppression, HIV, or other immunocompromised state.
- Have received treatment for any type of cancer within 5 years 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) biologic treatment for psoriasis (e.g., infliximab, adalimumab, etanercept, ustekinumab, secukinumab, or alefacept).
- Use within 30 days prior to the Baseline Visit of: 1) topical antipsoriatic drugs (salicylic acid, anthralin, coal tar, calcipotriene), 2) PUVA therapy, 3) systemic anti-inflammatory agents (e.g., mycophenolate mofetil, sulfasalazine, 6-thioguanine), or 4) UVB therapy.
- Use within 30 days prior to the Screening Visit of any product containing corticosteroids. Inhaled, intraocular, intranasal, etc. steroids are not allowed.
Show all 9Show fewer
- Subjects who have an abnormal sleep schedule or work overnight.
- Subjects with a known history of acute adrenal crisis, Addison's disease or decreased adrenal output, low pituitary function or pituitary tumors.
- Subjects who have a history of an adverse reaction to cosyntropin injection or similar test reagents.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Site 106
Arlington, Texas, 76014
Site 102
Encino, California, 91436
Site 101
Houston, Texas, 77030
Site 104
Irvine, California, 92697-1385
Site 109
Lebanon, New Hampshire, 03756
Site 107
New York, New York, 10155
Site 105
San Antonio, Texas, 78218
Site 100
San Diego, California, 92123
About this study
Official title: A Randomized, Parallel Group, Open-Label, Multicenter Study to Assess the Potential for Adrenal Suppression and Systemic Drug Absorption Following Multiple Dosing With DFD-01 (Betamethasone Dipropionate) Spray, 0.05%
To evaluate the potential of DFD-01 (betamethasone dipropionate) Spray, 0.05% to suppress the hypothalamic-pituitary-adrenal (HPA) axis.
Read the detailed description
To evaluate the potential of DFD-01 (betamethasone dipropionate) Spray, 0.05% to suppress the hypothalamic-pituitary-adrenal (HPA) axis when applied twice daily for 15 days or when applied twice daily for 29 days, in adolescent subjects with moderate to severe plaque psoriasis under maximal use conditions.
- Conditions
- Plaque Psoriasis
- Being tested
- DFD01 Spray
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DFD01 SprayDrug
Also called betamethasone
DFD-01 (betamethasone dipropionate) Spray, 0.05%
| Study group | Role | What they receive |
|---|---|---|
| DFD01 Spray Group 1 | Experimental | DFD01 spray, twice daily, 15 days Receives: Drug: DFD01 Spray |
| DFD01 Spray Group 2 | Experimental | DFD01 spray, twice daily, 29 days Receives: Drug: DFD01 Spray |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participants With HPA Axis Suppression at End of Treatment (Day 15 or Day 28) With Recovery 29 Days Later
Number of participants with HPA axis suppression at End of Treatment (day 15 or day 28) with recovery 29 days later, by measuring the level of cortisol in the blood after ACTH stimulation test
Measured: End of Treatment (day 15 or day 28) with recovery 29 days later
Participants With HPA Axis Suppression at Day 29
Number of participants with HPA axis suppression at Day 29, by measuring the level of cortisol in the blood after ACTH stimulation test
Measured: Day 29
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2015 (estimated)
- Study start19 Aug 2015
- Primary completion30 Mar 2019
- Study completion30 Mar 2019
Why it stopped: Not able to recruit patients with the current enrollment criteria.
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 3 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
- NCT02527421
- Sponsor's protocol ID
- DFD01-CD-013
- Status last verified
- Mar 2024
- First submitted
- 10 Aug 2015
- 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
- A Randomized, Parallel Group, Open-Label, Multicenter Study to Assess the Potential for Adrenal Suppression and Systemic Drug Absorption Following Multiple Dosing With DFD-01 (Betamethasone Dipropionate) Spray, 0.05%
- ClinicalTrials.gov ID
- NCT02527421
- Acronym / sponsor ID
- DFD01-CD-013
- Conditions
- Plaque Psoriasis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Not able to recruit patients with the current enrollment criteria.
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Primus PharmaceuticalsIndustry (pharma, biotech, devices)
- Collaborators
- Prosoft Clinical
- Study start
- 19 Aug 2015 (actual)
- Primary completion
- 30 Mar 2019 (actual)
- Study completion
- 30 Mar 2019 (actual)
- First posted
- 19 Aug 2015 (estimated)
- Results
- Posted 21 Oct 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the potential of DFD-01 (betamethasone dipropionate) Spray, 0.05% to suppress the hypothalamic-pituitary-adrenal (HPA) axis.
Detailed description
To evaluate the potential of DFD-01 (betamethasone dipropionate) Spray, 0.05% to suppress the hypothalamic-pituitary-adrenal (HPA) axis when applied twice daily for 15 days or when applied twice daily for 29 days, in adolescent subjects with moderate to severe plaque psoriasis under maximal use conditions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DFD01 Spray Group 1 | Experimental | Drug: DFD01 SprayDFD01 spray, twice daily, 15 days |
| DFD01 Spray Group 2 | Experimental | Drug: DFD01 SprayDFD01 spray, twice daily, 29 days |
Who may qualify
- Ages
- 12 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Subjects must weigh at least 55 pounds
- Subjects must present with a clinical diagnosis of stable (at least 3 months) plaque psoriasis.
- Subjects with psoriasis involving ≥ 10% BSA, not including the face, scalp, groin, axillae and other intertriginous areas..
- Subjects must have moderate to severe plaque psoriasis at the Baseline Visit.
- Subjects whose results from the screening ACTH stimulation test are considered normal (cortisol level >18 ug/dL at 30 minutes post stimulation) and show no other signs of abnormal HPA axis function or adrenal response.
Key exclusion criteria (9 listed)
- Current diagnosis of unstable forms of psoriasis including guttate, erythrodermic, exfoliative or pustular psoriasis.
- History of organ transplant requiring immunosuppression, HIV, or other immunocompromised state.
- Have received treatment for any type of cancer within 5 years 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) biologic treatment for psoriasis (e.g., infliximab, adalimumab, etanercept, ustekinumab, secukinumab, or alefacept).
- Use within 30 days prior to the Baseline Visit of: 1) topical antipsoriatic drugs (salicylic acid, anthralin, coal tar, calcipotriene), 2) PUVA therapy, 3) systemic anti-inflammatory agents (e.g., mycophenolate mofetil, sulfasalazine, 6-thioguanine), or 4) UVB therapy.
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: betamethasoneDFD-01 (betamethasone dipropionate) Spray, 0.05% | Drug | DFD01 Spray Group 1, DFD01 Spray Group 2 |
Primary outcome
Participants With HPA Axis Suppression at End of Treatment (Day 15 or Day 28) With Recovery 29 Days Later
Time frame: End of Treatment (day 15 or day 28) with recovery 29 days later
Number of participants with HPA axis suppression at End of Treatment (day 15 or day 28) with recovery 29 days later, by measuring the level of cortisol in the blood after ACTH stimulation test
Participants With HPA Axis Suppression at Day 29
Time frame: Day 29
Number of participants with HPA axis suppression at Day 29, by measuring the level of cortisol in the blood after ACTH stimulation test
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
8 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 Plaque Psoriasis, run by Primus Pharmaceuticals at 8 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 5 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: stopped early, 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 8 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 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 21 Oct 2021). 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?
Participants With HPA Axis Suppression at End of Treatment (Day 15 or Day 28) With Recovery 29 Days Later (time frame: End of Treatment (day 15 or day 28) with recovery 29 days later). The study lists 2 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.