PsoriasisPhase 2NCT03179605

Assess the Potential for Adrenal Suppression and Systemic Drug Absorption Following Multiple Dosing With DFD-06

A Phase 2 study testing DFD06 in people with Psoriasis, run by Primus Pharmaceuticals at 9 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Trial summary

The purpose of this study is to evaluate the potential of DFD-06 to suppress the hypothalamic-pituitary-adrenal (HPA) axis when applied twice daily for 15 days. Read more about this study

Who is it for?: Ages 6 to 17 years
Conditions the study is for: Psoriasis
What is being tested?: DFD06
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 22 participants
Where: 9 sitesUnited States
Study dates: 2 May 2017to 3 Jun 2020
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 6 to 17 years
All sexes
No healthy volunteers
Child

Who may be able to join

Subjects and the parent or legal guardian understand the study procedures and agree to participate by giving assent and written informed consent, respectively. Subject's parent or legal guardian must be willing to authorize use and disclosure of protected health information collected for the study.
Subjects must be at least 6 years and not more than 16.9 years of age, with body weight greater than or equal to 45 pounds at Screening.
Subjects must present with a clinical diagnosis of stable (at least 3 months) plaque psoriasis.
Subjects with psoriasis involving ≥10% Body Surface Area (BSA), not including the face, scalp, groin, axillae and other intertriginous areas at the Baseline Visit.
Subjects must have an Investigator Global Assessment (IGA) grade of at least 3 (moderate) at the Baseline Visit.

Who cannot join

Subject has a current diagnosis of unstable forms of psoriasis including guttate, erythrodermic, exfoliative or pustular psoriasis.
Subject has a history of organ transplant requiring immunosuppression, HIV, or other immunocompromised state.
Subject has 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.
Subject has a history or presence of intracranial hypertension.
Subject has had prolonged exposure to natural or artificial sources of ultraviolet radiation within 30 days prior to the initiation of treatment or is intending to have such exposure during the study that is thought by the investigator to likely modify the subject's disease

Trial locations and contacts

9 sites in 1 country.

City, postcode or hospital

9 sites in 1 country

United States9 sites

Site 106
Greenville, South Carolina, 29607
Investigational Site 102
Hialeah, Florida, 33010
Site 109
Hialeah, Florida, 33012
Investigational Site 101
Lincoln, Nebraska, 68522
Site 104
Madera, California, 93637
Site 107
Overland Park, Kansas, 66215
Site 108
Santa Ana, California, 92705
Site 105
Spokane, Washington, 99203
Site 103
St Louis, Missouri, 63141

Other trials in United States

About this study

Official title: An Open Label, Multicenter Study to Assess the Potential for Adrenal Suppression and Systemic Drug Absorption Following Multiple Dosing With DFD-06 in Pediatric Subjects With Moderate to Severe Plaque Psoriasis

The purpose of this study is to evaluate the potential of DFD-06 to suppress the hypothalamic-pituitary-adrenal (HPA) axis when applied twice daily for 15 days.

Read the detailed description

This is a 15-day, single arm, multicenter, multi-dose, open-label, two stage, sequential study. In the first stage, subjects who are at least 12 years of age and not more than 16.9 years (16 years and 11 months) of age with moderate to severe plaque psoriasis will be treated with DFD-06 (at least 20 completed subjects). In the second stage subjects who are at least 6 years of age and not more than 11.9 years (11 years and 11 months) of age with moderate to severe plaque psoriasis will be treated with DFD-06 (at least 20 completed subjects). An attempt will be made to enroll subjects throughout the age range of each cohort including the lower age range. DFD-06 will be applied twice daily to all affected areas on the body excluding face, scalp, groin, axillae and other intertriginous areas. Subjects must have ≥10% Body Surface Area (BSA) treated to achieve maximal use exposure.

Conditions: Psoriasis
Being tested: DFD06
Medical subject headings: Psoriasis

What participants receive

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

DFD06Drug
Also called clobetasol propionate, Impoyz Cream
Apply twice per day for 15 days

Study groups in NCT03179605
Study group	Role	What they receive
DFD-06 Cream	Experimental	This is a single arm, open label study and there will be no reference or control product used in this study Receives: Drug: DFD06

What is being measured

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

Percentage of Subjects With HPA Axis Suppression at Day 15
The percentage of subjects with abnormal cortisol response for ACTH stimulation test at Day 15 (cortisol level ≤18 µg/dL at 30 minutes post stimulation) is the primary variable
Measured: Day 15

Secondary outcomes (2)

Number of Participants With Improvement in IGA Grade From Baseline
Numbers of subjects with improvements by at least 1 pint in IGA grade will be provided as descriptive statistics.
Measured: Baseline up to Day 15
Plasma Concentration of Clobetasol Propionate
Plasma concentrations of clobetasol propionate after multiple doses of DFD-06 under maximal use condition with the final-to-be-marketed formulation.
Measured: Day 15 0 hour, 1 hour, 3 hours, 6 hours after application

Timeline

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

2 May 20173 Jun 2020

First posted7 Jun 2017
Study start2 May 2017
Primary completion3 Jun 2019
Study completion3 Jun 2020

Why it stopped: Difficulty in enrollment

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 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Sequential
Model description: In the first stage, subjects who are at least 12 years of age and not more than 16.9 years (16 years and 11 months) of age with moderate to severe plaque psoriasis will be treated with DFD-06 (at least 20 completed subjects). In the second stage subjects who are at least 6 years of age and not more than 11.9 years (11 years and 11 months) of age with moderate to severe plaque psoriasis will be treated with DFD-06 (at least 20 completed subjects).
Masking: None (open label)
Enrolment: 22 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03179605
Sponsor's protocol ID: DFD-06-CD-011
Status last verified: Mar 2024
First submitted: 12 May 2017
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

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

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Impact of Glucagon-like Peptide-1 (GLP-1) Analogs on Disease Outcomes in Psoriatic Arthritis: A Pragmatic Randomized Controlled Trial
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A Study to Evaluate the Efficacy and Safety of CS32582 in Participants With Moderate to Severe Plaque Psoriasis
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Assessing Psoriasis Treatment Outcomes
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Active, not recruitingPhase 3
Guselkumab vs Golimumab in PsA TNF Inadequate Responder Patients
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Cosmetic Efficacy Evaluation of Hydraporin AI Cream in Individuals With Atopic Dermatitis and Psoriasis
Atopic Dermatitis, Psoriasis

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: An Open Label, Multicenter Study to Assess the Potential for Adrenal Suppression and Systemic Drug Absorption Following Multiple Dosing With DFD-06 in Pediatric Subjects With Moderate to Severe Plaque Psoriasis
ClinicalTrials.gov ID: NCT03179605
Acronym / sponsor ID: DFD-06-CD-011
Conditions: Psoriasis
Phase: Phase 2
Study type: Interventional
Recruitment status: TerminatedReason stopped: Difficulty in enrollment
Enrolment: 22 participants (actual)
Lead sponsor: Primus PharmaceuticalsIndustry (pharma, biotech, devices)
Collaborators: Prosoft Clinical
Study start: 2 May 2017 (actual)
Primary completion: 3 Jun 2019 (actual)
Study completion: 3 Jun 2020 (actual)
First posted: 7 Jun 2017 (actual)
Results: Posted 1 Jun 2022

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 DFD-06 to suppress the hypothalamic-pituitary-adrenal (HPA) axis when applied twice daily for 15 days.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Sequential
Masking: None (open label)
Number of arms: 1
Model description: In the first stage, subjects who are at least 12 years of age and not more than 16.9 years (16 years and 11 months) of age with moderate to severe plaque psoriasis will be treated with DFD-06 (at least 20 completed subjects). In the second stage subjects who are at least 6 years of age and not more than 11.9 years (11 years and 11 months) of age with moderate to severe plaque psoriasis will be treated with DFD-06 (at least 20 completed subjects).

Arm	Type	Receives
DFD-06 Cream	Experimental	Drug: DFD06This is a single arm, open label study and there will be no reference or control product used in this study

Who may qualify

Ages: 6 to 17 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (5 listed)

Subjects and the parent or legal guardian understand the study procedures and agree to participate by giving assent and written informed consent, respectively. Subject's parent or legal guardian must be willing to authorize use and disclosure of protected health information collected for the study.
Subjects must be at least 6 years and not more than 16.9 years of age, with body weight greater than or equal to 45 pounds at Screening.
Subjects must present with a clinical diagnosis of stable (at least 3 months) plaque psoriasis.
Subjects with psoriasis involving ≥10% Body Surface Area (BSA), not including the face, scalp, groin, axillae and other intertriginous areas at the Baseline Visit.
Subjects must have an Investigator Global Assessment (IGA) grade of at least 3 (moderate) at the Baseline Visit.

Key exclusion criteria (5 listed)

Subject has a current diagnosis of unstable forms of psoriasis including guttate, erythrodermic, exfoliative or pustular psoriasis.
Subject has a history of organ transplant requiring immunosuppression, HIV, or other immunocompromised state.
Subject has 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.
Subject has a history or presence of intracranial hypertension.
Subject has had prolonged exposure to natural or artificial sources of ultraviolet radiation within 30 days prior to the initiation of treatment or is intending to have such exposure during the study that is thought by the investigator to likely modify the subject's disease

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
DFD06Also: clobetasol propionate, Impoyz CreamApply twice per day for 15 days	Drug	DFD-06 Cream

Primary outcome

Percentage of Subjects With HPA Axis Suppression at Day 15
Time frame: Day 15
The percentage of subjects with abnormal cortisol response for ACTH stimulation test at Day 15 (cortisol level ≤18 µg/dL at 30 minutes post stimulation) is the primary variable

2 secondary outcomes

Number of Participants With Improvement in IGA Grade From Baseline
Time frame: Baseline up to Day 15
Plasma Concentration of Clobetasol Propionate
Time frame: Day 15 0 hour, 1 hour, 3 hours, 6 hours after application

Results and safety

Results posted to the registry on 1 Jun 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
DFD-06 Cream	22	21

Primary outcome: Percentage of Subjects With HPA Axis Suppression at Day 15

Time frame: Day 15. Count of participants. Unit: Participants

Measure	DFD-06 Cream n = 21
Value	3

Population analysed: The Evaluable population included those subjects in the Safety population who had both Screening and Day 15 serum cortisol data (pre- and post-cosyntropin stimulation) and had a normal response to Screening Cosyntropin Stimulation Test with a 30-minute post-stimulation cortisol level of \> 18 μg/dL and applied at least 80% of expected (29) applications

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: 1 month. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
DFD-06 Cream	0 of 22 (0%)	8 of 22 (36.4%)	0 of 22

Limitations and caveats (from the sponsor): Early termination due to low enrollment with completion of 12 to 16.9 years old group only; the planned 6 to 11.9 years of age did not enroll.

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

Related trials for Psoriasis

RecruitingPhase 4
Impact of Glucagon-like Peptide-1 (GLP-1) Analogs on Disease Outcomes in Psoriatic Arthritis: A Pragmatic Randomized Controlled Trial
Psoriatic Arthritis (PsA)
RecruitingPhase 1/2
A Study to Evaluate the Efficacy and Safety of CS32582 in Participants With Moderate to Severe Plaque Psoriasis
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Not yet recruiting
Assessing Psoriasis Treatment Outcomes
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Active, not recruitingPhase 3
Guselkumab vs Golimumab in PsA TNF Inadequate Responder Patients
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Not yet recruiting
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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.

9 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 DFD06 in people with Psoriasis, run by Primus Pharmaceuticals at 9 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 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: 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 9 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 1 Jun 2022). 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 Subjects With HPA Axis Suppression at Day 15 (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 NCT03179605.

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.