Plaque PsoriasisPhase 3NCT05763082
Bioequivalence Study of Two Treatments for the Treatment of Plaque Psoriasis
A Phase 3 study testing roflumilast cream 0.3% and Zoryve in people with Plaque Psoriasis, run by Padagis LLC at 1 site in United States.
Trial summary
To compare the safety and efficacy of Padagis' product to an FDA approved product for the treatment of plaque psoriasis Read more about this study
- Who is it for?
- Ages 12 to 75 years
- Conditions the study is for
- Plaque Psoriasis
- What is being tested?
- roflumilast cream 0.3% and Zoryve
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 416 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Feb 2023to 8 Aug 2023
- 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 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Signed IRB approved written informed consent/assent
- 12 to 75 years of age, inclusive.
- Subjects must have a clinical diagnosis of stable symptomatic plaque psoriasis.
- Baseline Investigator's Global Assessment Score of 3 (moderate).
- Subjects must have a Body Surface Area (BSA) between 2% to 20%
- Females of child bearing potential (excluding women who are surgically sterilized (tubal ligation or bilateral oophorectomy or hysterectomy) or post-menopausal for at least 2 years), in addition to having a negative urine pregnancy test at Visit 1/Day1(Baseline), must be willing to use an acceptable form of birth control during the study.
Who cannot join
- Pregnant, breastfeeding or planning a pregnancy within the period of their study participation period.
- Current diagnosis of unstable forms of psoriasis in the treatment area.
- History of unresponsiveness to topical treatment for psoriasis
- Presence of any other skin condition that, in the Investigator's opinion, might interfere with psoriasis diagnosis and/or evaluations
- Any uncontrolled, chronic or serious disease or medical condition that would prevent participation in a clinical trial, or, in judgment of the investigator, would put the subject at undue risk or might confound the study assessments
- Use of medicated make-up throughout the study and significant change in the use of consumer products within 30 days (1 month) of study entry and throughout the study
- Subject consumes excessive alcohol, abuses drugs, or has a condition that could compromise the subject's ability to comply with study requirements.
- Subjects who in the opinion of the investigator, are unlikely to be able to follow the restrictions of the protocol and complete the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multi-Center, Double-Blind, Randomized, Vehicle-Controlled, Parallel-Group Study to Compare Padagis' Roflumilast Cream 0.3% to Arcutis's Zoryve™ (Roflumilast Cream 0.3%) Cream and Both Active Treatments to a Vehicle Control in the Treatment of Plaque Psoriasis
To compare the safety and efficacy of Padagis' product to an FDA approved product for the treatment of plaque psoriasis
- Conditions
- Plaque Psoriasis
- Being tested
- roflumilast cream 0.3%, Zoryve, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
roflumilast cream 0.3%Drug
test product
ZoryveDrug
Reference Listed Drug product
PlaceboDrug
placebo
| Study group | Role | What they receive |
|---|---|---|
| Padagis active product | Experimental | Not described Receives: Drug: roflumilast cream 0.3% |
| Reference product | Active comparator | Not described Receives: Drug: Zoryve |
| Padagis placebo product | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Investigator's Global Assessment (IGA)
percentage of subjects at Day 56 who achieve Treatment Success, which is defined as an IGA score of None (0) or Minimal (1) with a 2-grade improvement from Day 1
Measured: Day 1 to Day 56
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2023
- Study start7 Feb 2023
- Primary completion8 Aug 2023
- Study completion8 Aug 2023
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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 416 participants (actual)
Sponsor and investigators
- Lead sponsor
- Padagis LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05763082
- Sponsor's protocol ID
- PAD-NY-22-05
- Status last verified
- Aug 2026
- First submitted
- 28 Feb 2023
- Last updated
- 26 Aug 2026
- 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 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-Center, Double-Blind, Randomized, Vehicle-Controlled, Parallel-Group Study to Compare Padagis' Roflumilast Cream 0.3% to Arcutis's Zoryve™ (Roflumilast Cream 0.3%) Cream and Both Active Treatments to a Vehicle Control in the Treatment of Plaque Psoriasis
- ClinicalTrials.gov ID
- NCT05763082
- Acronym / sponsor ID
- PAD-NY-22-05
- Conditions
- Plaque Psoriasis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 416 participants (actual)
- Lead sponsor
- Padagis LLCIndustry (pharma, biotech, devices)
- Study start
- 7 Feb 2023 (actual)
- Primary completion
- 8 Aug 2023 (actual)
- Study completion
- 8 Aug 2023 (actual)
- First posted
- 10 Mar 2023 (actual)
- Results
- Posted 26 Aug 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To compare the safety and efficacy of Padagis' product to an FDA approved product for the treatment of plaque psoriasis
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Padagis active product | Experimental | Drug: roflumilast cream 0.3% |
| Reference product | Active comparator | Drug: Zoryve |
| Padagis placebo product | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 12 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Signed IRB approved written informed consent/assent
- 12 to 75 years of age, inclusive.
- Subjects must have a clinical diagnosis of stable symptomatic plaque psoriasis.
- Baseline Investigator's Global Assessment Score of 3 (moderate).
- Subjects must have a Body Surface Area (BSA) between 2% to 20%
Key exclusion criteria (8 listed)
- Pregnant, breastfeeding or planning a pregnancy within the period of their study participation period.
- Current diagnosis of unstable forms of psoriasis in the treatment area.
- History of unresponsiveness to topical treatment for psoriasis
- Presence of any other skin condition that, in the Investigator's opinion, might interfere with psoriasis diagnosis and/or evaluations
- Any uncontrolled, chronic or serious disease or medical condition that would prevent participation in a clinical trial, or, in judgment of the investigator, would put the subject at undue risk or might confound the study assessments
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 |
|---|---|---|
| roflumilast cream 0.3%test product | Drug | Padagis active product |
| ZoryveReference Listed Drug product | Drug | Reference product |
| Placeboplacebo | Drug | Padagis placebo product |
Primary outcome
Investigator's Global Assessment (IGA)
Time frame: Day 1 to Day 56
percentage of subjects at Day 56 who achieve Treatment Success, which is defined as an IGA score of None (0) or Minimal (1) with a 2-grade improvement from Day 1
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2026.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing roflumilast cream 0.3% and Zoryve in people with Plaque Psoriasis, run by Padagis LLC at 1 site 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 6 inclusion and 8 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 26 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 26 Aug 2026). 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?
Investigator's Global Assessment (IGA) (time frame: Day 1 to Day 56). 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 26 Aug 2026; AzTrials last refreshed its copy on 8 Nov 2026.