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

NCT05203315 | Completed Phase 3 DMC FDA Drug

• 1 other identifier: PDCR-000245
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Plaque Psoriasis

Outcome Measures

Primary Outcomes (1)

• Treatment Success by Percent Investigators Global Assessment (IGA)

  The primary efficacy endpoint will be the percent of subjects with treatment success, defined as an Investigators Global Assessment (IGA) score equating to "Clear". 0: Clear, 1: Mild, 2: Moderate, 3: Severe.

  28 Weeks

Study Arms (2)

Treatment Group A

EXPERIMENTAL

Subjects whose baseline Itch and/or Burning/Stinging Score is less than 2 (moderate), one tube of Duobrii along with one jar of CeraVe cream, will be dispensed to the subject at the Baseline visit. The study participant will be instructed to apply the CeraVe cream to the treatment area twice daily and advised to apply a thin layer of the Duobrii only to the affected skin once daily in the evening.

Drug: Duobrii 0.01 % / 0.045 % Topical Lotion; Drug: CeraVe, Topical Cream

Treatment Group B

EXPERIMENTAL

Subjects whose baseline Itch and/or Burning/Stinging Score is greater than or equal to 2 (moderate), in addition to one tube of Duobrii along with one jar of CeraVe cream, the participant will be given a tube of hydrocortisone 1% cream and instructed to apply to the treatment area twice daily for 5 days, along with CeraVe cream. Starting at day 6 and ongoing, subjects will be instructed to discontinue the hydrocortisone cream and initiate Duobrii application every night, while continuing the CeraVe cream twice daily.

Drug: Duobrii 0.01 % / 0.045 % Topical Lotion; Drug: CeraVe, Topical Cream

Interventions

Duobrii 0.01 % / 0.045 % Topical Lotion DRUG

Duobrii® lotion (halobetasol propionate \[HP\] and tazarotene \[Taz\] 0.01%/0.045%) is currently on the market for the treatment of moderate to severe stable plaque psoriasis, and is classified as a high potency (Class II) corticosteroid.

Treatment Group A; Treatment Group B

CeraVe, Topical Cream DRUG

CeraVe cream will be used twice daily (in the morning and again in the evening) by the study participant in conjunction with Duobrii and Hydrocortisone cream.

Treatment Group A; Treatment Group B

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Austin Institute for Clinical Research: lead
• OrthoDermatologics: collaborator

Study Sites (2)

Austin Institute for Clinical Research, Inc.

Houston, Texas, 77056, United States

Location

Austin Institute for Clinical Research, Inc.

Pflugerville, Texas, 78660, United States

Location

Study Officials

• Edward Lain, MD, MBA

  Austin Institute for Clinical Research

  PRINCIPAL INVESTIGATOR

• Megan Couvillion, MD

  Austin Institute for Clinical Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Model Details: Open Label Study

Study Record Dates

• First Submitted: December 2, 2021
• First Posted: January 24, 2022
• Study Start: January 13, 2022
• Primary Completion: October 4, 2023
• Study Completion: October 4, 2023
• Last Updated: July 19, 2024

Record last verified: 2024-07

Locations

US (2)