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Can a generic cream match the brand for psoriasis relief?

NCT ID NCT05763082

Disease control Sponsor: Padagis LLC Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 26, 2026 · Last updated Aug 27, 2026 · Updated 1 time

Summary

This Phase 3 trial tests whether a generic version of roflumilast cream 0.3% works as well as the approved Zoryve cream for treating plaque psoriasis. About 416 people aged 12 to 75 with moderate psoriasis will apply one of the creams or a placebo daily. The main goal is to see if the generic is as effective as the brand in clearing skin lesions after 8 weeks.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
roflumilast cream 0.3%
What this could lead to
If successful, this could provide a more affordable, equally effective topical treatment option for plaque psoriasis, potentially improving access to care.
What could go wrong
This is a comparative trial, not a new discovery. The generic may not prove as effective as the brand, and results may not apply to all psoriasis severities.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

416 people

The number who actually took part.

Started

Feb 2023

Finished

Aug 2023

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

12 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Signed IRB approved written informed consent/assent 2. 12 to 75 years of age, inclusive. 3. Subjects must have a clinical diagnosis of stable symptomatic plaque psoriasis. 4. Baseline Investigator's Global Assessment Score of 3 (moderate). 5. Subjects must have a Body Surface Area (BSA) between 2% to 20% 6. 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. Exclusion Criteria: 1. Pregnant, breastfeeding or planning a pregnancy within the period of their study participation period. 2. Current diagnosis of unstable forms of psoriasis in the treatment area. 3. History of unresponsiveness to topical treatment for psoriasis 4. Presence of any other skin condition that, in the Investigator's opinion, might interfere with psoriasis diagnosis and/or evaluations 5. 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 6. 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 7. Subject consumes excessive alcohol, abuses drugs, or has a condition that could compromise the subject's ability to comply with study requirements. 8. Subjects who in the opinion of the investigator, are unlikely to be able to follow the restrictions of the protocol and complete the study

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Conditions

The condition(s) this trial relates to.

psoriasis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Plaque psoriasis

Contacts and locations

Locations

  • DS Research

    Louisville, Kentucky, 40241, United States

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