Investigator Initiated Trial to Study Duobrii® Lotion in the Treatment of Mild Plaque Psoriasis in Adults

Completed · Phase 3

Conditions studied: Plaque Psoriasis

In brief

This study seeks to evaluate the safety, tolerability, and efficacy of topical Duobrii® Lotion in adult subjects with mild plaque psoriasis.

Key facts

Study ID

NCT05203315

Run by

Austin Institute for Clinical Research

People needed

21

Starts

2022-01-13

Expected to finish

2023-10-04

Last updated by the study team

2024-07-19

Who can join

Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female, of any race, at least 18 years of age.
• Freely provides both verbal and written informed consent.
• Is willing and able to avoid prolonged exposure of the treatment area to ultraviolet radiation (natural and artificial) for the duration of the study.
• Has a clinical diagnosis of stable plaque psoriasis at least 6 months before the Baseline visit, confirmed by prior medical documentation and/or according to the subject/caregiver report.
• Has an IGA score of 2 at the Baseline visit. (The face, genitals, axillae, and intertriginous areas are to be excluded from this assessment, if psoriasis is present).
• Is in good general health based on the subject's medical history.
• If female and of childbearing potential, must have a negative urine pregnancy test at the Screening visit and Baseline visit prior to randomization.
• IF female, is either not of childbearing potential, defined as postmenopausal for at least 12 months or surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy), or is of childbearing potential and practicing 1 of the following methods of birth control throughout the study:
• Condom with spermicide, diaphragm with spermicide, intrauterine device, or abstinence
• Stable use of a hormonal contraceptive (oral, implant, insertable, injection or transdermal patch) for at least 3 months prior to the Baseline visit.
• Subject is willing to comply with study instructions and return to the clinic for required visits.

You may not qualify if…

• Has spontaneously improving or rapidly deteriorating plaque psoriasis or presence of guttate or pustular psoriasis, as determined by the investigator.
• Presents with psoriasis that was treated with prescription medication and failed to respond to treatment, even partially or temporarily, as determined by the investigator.
• Presents with any concurrent skin condition that could interfere with the evaluation of the treatment areas, as determined by the investigator.
• Is pregnant, nursing an infant, or planning a pregnancy during the study period.
• Has received treatment with any investigational drug or device within 60 days or 5 drug half-lives (whichever is longer) prior to the Baseline visit, or is concurrently participating in another clinical study with an investigational drug or device. Subject may be enrolled in the follow-up phase of a COVID-19 vaccine trial.
• Received treatment with any topical antipsoriatic drug product within 14 days prior to the Baseline visit.
• Has used any phototherapy (including laser), photochemotherapy, or non-biologic systemic psoriasis therapy (such as newer oral psoriasis medications (eg Otezla), systemic corticosteroids, methotrexate, retinoids or cyclosporine) within 4 weeks prior to the Baseline visit.
• Has used immunomodulatory therapy (biologics) known to affect psoriasis within 3 months of the Baseline visit.
• Has had prolonged exposure to natural or artificial sources of ultraviolet radiation within 4 weeks prior to the Baseline visit or is intending to have exposure during the study thought likely by the investigator to modify the subject's psoriasis.
• Is currently using lithium or Plaquenil.
• Has a history of hypersensitivity or allergic reaction to any of Duobrii constituents.
• Is unable to be compliant with study procedures, study drug administration requirements, study visit schedules, and prohibitions regarding the use of concomitant medications/therapies.
• Is unable to communicate or cooperate with the investigator.
• Has any underlying disease (e.g., uncontrolled diabetes, cardiac disease) that the investigator deems uncontrolled that poses a concern for the subject's safety while participating on the study.
• Has a history of malignancy within 5 years before the Screening visit, except completely treated in situ carcinoma of the cervix or completely treated and resolved non-metastatic squamous or basal cell carcinoma of the skin with no evidence of recurrence in the past 12 weeks.
• Has a planned or expected major surgical procedure during the clinical study.
• Has a history of drug or alcohol abuse as determined by the investigator.
• Is considered by the investigator, for any other reason, to be an unsuitable candidate for the study.
• Are investigator site personnel directly affiliated with this study and/or their immediate families. Immediate family is defined as a spouse, parent, child, or sibling, whether biological or legally adopted.
• Are employees of Bausch Health.

Where it is running

• Austin Institute for Clinical Research, Inc. — Houston, Texas, United States
• Austin Institute for Clinical Research, Inc. — Pflugerville, Texas, United States

Full record on ClinicalTrials.gov

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