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Clinical Trial Summary

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

Clinical Trial Description

Psoriasis is a common disease of both males and females, that can range in severity from very mild to very severe. Patient age, severity of disease, and the type and extent of the body surface area are often taken into consideration when selecting therapy. There is not a cure for this particular disease and treatment options often focus on relieving moderate to severe symptoms associated with the disease. Biologic treatments are often used to treat the symptoms of moderate to severe plaque psoriasis. These symptoms often include inflammation, induration, and scaling. However, this study aims to research Duobrii® Lotion for the treatment of mild stable plaque psoriasis in male and female adults. Approximately 40 subjects who meet the study entry criteria will be enrolled. For those subjects whose baseline Itch and/or Burning/Stinging Score is <2 (moderate), one tube of Duobrii, along with one jar of CeraVe cream, will be dispensed to the subject at the Baseline visit. Both Duobrii and CeraVe cream will be applied topically to the affected areas (as determined by the investigator at baseline). Subjects will be advised to apply the CeraVe cream twice daily (in the morning, and again in the evening after applying Duobrii), and advised to apply a thin layer of Duobrii only to affected skin once daily in the evening. For those subjects whose baseline Itch and/or Burning/Stinging Score is >=2 (moderate) in the treatment areas, in addition to being dispensed Duobrii and CeraVe, the participants 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. Affected areas on the palms and soles, while not included in the Investigators Global Assessment, hereinafter referred to as IGA, or Body Surface Area, hereinafter referred to as BSA, assessment, are considered treatment areas and therefore are subject to the same guidelines for Itch and/or Burning/Stinging Scores as noted above. Subjects will be instructed to make an unscheduled visit if the participant believes their psoriasis has cleared in between scheduled study visits, and will be allowed to discontinue the Duobrii if the investigator agrees their IGA=0 (clear). Subjects will be advised to restart Duobrii once the investigator determines the subject has an IGA=2 (mild). The duration of the study will be 28 weeks. The initial application will be made by the subject per instruction from the study staff either at the investigational center, or at their home. The subjects will be instructed to avoid exposure to direct sunlight, artificial ultraviolet light sources and to use protective clothing to prevent sunburn. Subjects will apply their once daily treatments at home as explained by the study coordinator or designee at each investigational center. During post-baseline study visits (Weeks 2, 4, 6, 8, 12, 16, 20 and 24) the subjects will be asked to return their containers of Duobrii and CeraVe which will be evaluated for drug usage compliance. New containers will be dispensed as needed. During the study, subjects will be allowed to use investigator-approved non-medicated cleansers and sunscreens; no other skin care products will be permitted on the treatment areas. The investigator will assess the areas affected by psoriasis at each study visit. All areas affected by psoriasis (excluding face, genitals, axillae, and intertriginous areas) are to be treated with Duobrii and CeraVe. Information on reported and observed adverse events (AEs) will be obtained at each visit. For all female subjects of childbearing potential, urine pregnancy testing will be performed at Screening, Baseline, and each subsequent visit. The Dermatology Life Quality Index questionnaire (DLQI) questionnaire will be administered to subjects at Day 0 (Baseline), each post-baseline visit, and the final visit. The DLQI will not be completed at the Screening visit, Phone contact visit, or Unscheduled visits. Subjects who terminate study participation early will be asked to complete all Week 28 assessments, as appropriate, prior to commencement of any alternative therapy for psoriasis (if possible). Subjects who discontinue from the study during the treatment period will not be replaced and these subjects may be asked to return for the week 28 visit after the last treatment visit. If signs or symptoms develop in the selected treatment areas during the treatment period that restrict daily activities or make continued application of Duobrii difficult due to discomfort, the investigator may instruct the subject to temporarily interrupt use of Duobrii and to resume application of Duobrii once the signs/symptoms have subsided. The investigator should try to minimize study drug interruptions; and if needed, make best efforts to limit a "drug holiday" to 5 days. If Duobrii interruption does exceed 5 consecutive days, the investigator may restart Duobrii at a decreased frequency. If Duobrii is interrupted, discontinued, or a concomitant medication is used to treat a sign/symptom, an adverse event shall be recorded. Subjects who discontinue from the study due to AEs will return for the 28 week visit and will be instructed to follow-up with their primary care physician, if indicated. Any subject who has an AE during the treatment period will be followed by the investigator until resolution (return to normal or to the baseline state) or stabilization, as determined by the investigator. In addition, application of study drug may be delayed or halted at any time if ongoing safety data evaluations (including reports of local skin reactions, such as skin atrophy, or severe AEs) raise concern for subject safety. If the subject participation is suspended, all the subject's safety data will be reviewed by the investigator to determine course of action. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT05203315
Study type Interventional
Source Austin Institute for Clinical Research
Contact Celeste Katona, BA
Phone 5122792545
Status Recruiting
Phase Phase 3
Start date January 13, 2022
Completion date December 1, 2023

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