Plaque PsoriasisPhase 2BDS1307NCT02070965
DFD01 Spray vs Comp01 Lotion HPA Axis Suppression Study in Patients With Moderate to Severe Plaque Psoriasis
A Phase 2 study testing DFD01 Spray and Comp01 Lotion in people with Plaque Psoriasis, run by Primus Pharmaceuticals at 12 sites in United States.
Trial summary
The purpose of this study is to evaluate the potential of DFD01 spray to suppress the HPA (hypothalamic-pituitary-adrenal) axis as compared to Comp01 lotion when applied twice daily for 15 days. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Plaque Psoriasis
- What is being tested?
- DFD01 Spray and Comp01 Lotion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 12 sitesUnited States
- Study dates
- Jan 2014to Oct 2014
- Phase
- Phase 2
- 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 to 90 years
- 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 psoriasis.
- Subjects with psoriasis involving 20 to 50% BSA, not including the face, scalp, groin, axillae and other intertriginous areas.
- Subjects must have an IGA grade of at least 3 (moderate) 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 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 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) immunosuppressive drugs (e.g., tacrolimus, pimecrolimus), or 2) systemic antipsoriatic treatment (e.g., methotrexate, cyclosporine, hydroxyurea)
- 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.
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- Subjects who have an abnormal sleep schedule or work at night.
- 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
12 sites in 1 country.
12 sites in 1 country
United States12 sites
Academic Dermatology Associates
Albuquerque, New Mexico, 87106
DermResearch, Inc.
Austin, Texas, 78759
California Dermatology and Clinical Research Institute
Encinitas, California, 92024
Encino Research Center T. Joseph Raoof MD, Inc.
Encino, California, 91436
Bettencourt Skin Center
Henderson, Nevada, 89074
Dermatology Consulting Services
High Point, North Carolina, 27262
Center for Clinical Studies, LTD. LLP
Houston, Texas, 77004
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
Suzanne Bruce and Associates, PA The Center for Skin Research Katy/Cinco Ranch
Katy, Texas, 77494
Tennessee Clinical Research Center
Nashville, Tennessee, 37215
Paddington Testing Company, Inc.
Philadelphia, Pennsylvania, 19101
Redwood Dermatology Research
Santa Rosa, California, 95403
About this study
Official title: Randomized Parallel Group Open-Label Multicenter Study to Assess the Potential for Adrenal Supp and Syst Drug Abs Following Multi Dosing With DFD-01 (Betamethasone Dipropionate) Spray 0.05% in Adol Subjects With Mod to Sev Plaque Psoriasis
The purpose of this study is to evaluate the potential of DFD01 spray to suppress the HPA (hypothalamic-pituitary-adrenal) axis as compared to Comp01 lotion when applied twice daily for 15 days.
- Conditions
- Plaque Psoriasis
- Being tested
- DFD01 Spray, Comp01 Lotion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DFD01 SprayDrug
Comp01 LotionDrug
| Study group | Role | What they receive |
|---|---|---|
| DFD01 Spray Group 1 | Experimental | DFD01 Spray, bid, 28 days Receives: Drug: DFD01 Spray |
| Comp01 Lotion | Active comparator | Comp01 Lotion, bid, 14 days Receives: Drug: Comp01 Lotion |
| DFD01 Spray Group 2 | Experimental | DFD01 Spray, bid, 14 days Receives: Drug: DFD01 Spray |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Number of Subjects With HPA Axis Suppression
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 posted25 Feb 2014 (estimated)
- Study startJan 2014
- Primary completionOct 2014
- Study completionOct 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.
- Publications (1)Papers the sponsor has linked to this study.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 75 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
- NCT02070965
- Sponsor's protocol ID
- BDS1307
- Acronym
- BDS1307
- Status last verified
- Mar 2024
- First submitted
- 21 Feb 2014
- Last updated
- 7 Mar 2024
- Results posted
- Yes, on ClinicalTrials.gov
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
- Randomized Parallel Group Open-Label Multicenter Study to Assess the Potential for Adrenal Supp and Syst Drug Abs Following Multi Dosing With DFD-01 (Betamethasone Dipropionate) Spray 0.05% in Adol Subjects With Mod to Sev Plaque Psoriasis
- ClinicalTrials.gov ID
- NCT02070965
- Acronym / sponsor ID
- BDS1307 / BDS1307
- Conditions
- Plaque Psoriasis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Primus PharmaceuticalsIndustry (pharma, biotech, devices)
- Collaborators
- Prosoft Clinical
- Study start
- Jan 2014
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 25 Feb 2014 (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 purpose of this study is to evaluate the potential of DFD01 spray to suppress the HPA (hypothalamic-pituitary-adrenal) axis as compared to Comp01 lotion when applied twice daily for 15 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| DFD01 Spray Group 1 | Experimental | Drug: DFD01 SprayDFD01 Spray, bid, 28 days |
| Comp01 Lotion | Active comparator | Drug: Comp01 LotionComp01 Lotion, bid, 14 days |
| DFD01 Spray Group 2 | Experimental | Drug: DFD01 SprayDFD01 Spray, bid, 14 days |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subjects must present with a clinical diagnosis of stable (at least 3 months) plaque psoriasis.
- Subjects with psoriasis involving 20 to 50% BSA, not including the face, scalp, groin, axillae and other intertriginous areas.
- Subjects must have an IGA grade of at least 3 (moderate) 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 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 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) immunosuppressive drugs (e.g., tacrolimus, pimecrolimus), or 2) systemic antipsoriatic treatment (e.g., methotrexate, cyclosporine, hydroxyurea)
- 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 Spray | Drug | DFD01 Spray Group 1, DFD01 Spray Group 2 |
| Comp01 Lotion | Drug | Comp01 Lotion |
Primary outcome
The Number of Subjects With HPA Axis Suppression
Time frame: Day 15
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.
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing DFD01 Spray and Comp01 Lotion in people with Plaque Psoriasis, run by Primus Pharmaceuticals at 12 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 4 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 12 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
The Number of Subjects With HPA Axis Suppression (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 NCT02070965, 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.