Combination of Halobetasol Propionate and Tazarotene Lotion (Duobrii®) for Palmoplantar Plaque Type Psoriasis

NCT04720105 | Completed Phase 4 Results FDA Drug

• 1 other identifier: GCO 20-0608
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this research study is to examine the effect of Duobrii® (halobetasol propionate 0.01%/tazarotene 0.045% lotion, HP/TAZ) on plaque type psoriasis of the hands and/or feet.

Conditions

Palmoplantar Psoriasis; Plaque Psoriasis

Keywords

Palmoplantar; Psoriasis; Plaque

Outcome Measures

Primary Outcomes (1)

• Palmoplantar Physician Global Assessment (ppPGA)

  Number of participants achieving Palmoplantar Physician Global Assessment (ppPGA) of 0 (clear) or 1 (almost clear/minimal) after 24 weeks of treatment. The ppPGA is based on the Investigators Global Assessment (IGA) modified version 11, specifically applied to the hands and/or feet: 0 (clear), 1 (almost clear/minimal), 2 (mild), 3 (moderate), 4 (marked/moderate-to-severe), 5 (severe)

  Baseline and Week 24

Secondary Outcomes (2)

• Dermatology Quality of Life Index (DLQI)

  Baseline and Week 24

• Numerical Rating Scale (NRS)

  Baseline and Week 24

Study Arms (1)

Participants with plaque type psoriasis

EXPERIMENTAL

Participants with plaque type psoriasis to be treated with Duobrii® (halobetasol propionate 0.01%/tazarotene 0.045% lotion) to be applied thinly once a day on the affected areas of hands and/or feet.

Drug: Duobrii®

Interventions

Duobrii® DRUG

Duobrii® (halobetasol propionate 0.01%/tazarotene 0.045% lotion, HP/TAZ) will be provided at weeks 0,2,8,16 for a total of 24 weeks.

Also known as: Halobetasol propionate 0.01%/tazarotene 0.045% lotion, HP/TAZ

Participants with plaque type psoriasis

Eligibility Criteria

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

You may qualify if:

• Subject is able to provide written, informed consent and comply with the study protocol.
• Subject is at least 18 years of age.
• Subject has a diagnosis of plaque-type palmar and/or plantar psoriasis.
• Patient has at least one psoriatic plaque outside of the palms and soles or psoriatic nail findings.
• Subject has a ppPGA ≥ 3 at screening/baseline visit.
• Subject is using adequate birth control during the study period as defined as follows:
• Option 1: Any one of the following highly effective methods: hormonal contraception (oral, injection, implant, transdermal patch, vaginal ring); intrauterine device (IUD); tubal ligation; or partner's vasectomy; OR
• Option 2: Male or female condom (latex condom or nonlatex condom NOT made out of natural \[animal\] membrane \[for example, polyurethane\]; PLUS one additional barrier method: (a) diaphragm with spermicide; (b) cervical cap with spermicide; or (c) contraceptive sponge with spermicide.
• Option 3: Abstinence from sex when it is a lifestyle choice, and not just a social circumstance.

You may not qualify if:

• Subject is not able to provide written, informed consent and comply with the study protocol.
• Subject is less than 18 years of age.
• Subject has non-plaque type psoriasis on the hands and/or feet.
• Patient does not have any evidence of psoriasis elsewhere.
• Subject has concurrent cutaneous disease affecting the hands and/or feet that would interfere with assessments.
• Subject has a ppPGA \< 3 at screening/baseline visit.
• Subject refuses to discontinue concomitant prescription medications on hands and/or feet.
• Subject has used topical prescription treatments or received phototherapy treatment for psoriasis within 2 weeks of screening/baseline visit.
• Subject has used intralesional kenalog within 4 weeks of screening/baseline visit.
• Subject has taken oral treatments for psoriasis within 4 weeks of screening/baseline visit.
• Subject has received any treatment with biologic medications within 5 half-lives (if known) or 16 weeks prior to screening/baseline, whichever is longer.
• Subject refuses to use adequate birth control during the duration of the study period.
• Subject is currently pregnant or breastfeeding.

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead
• Bausch Health Americas, Inc.: collaborator

Study Sites (1)

Mount Sinai Downtown Union Square

New York, New York, 10003, United States

Location

Related Publications (6)

• Engin B, Askin O, Tuzun Y. Palmoplantar psoriasis. Clin Dermatol. 2017 Jan-Feb;35(1):19-27. doi: 10.1016/j.clindermatol.2016.09.004. Epub 2016 Sep 10.

  PMID: 27938808 BACKGROUND

• Raposo I, Torres T. Palmoplantar Psoriasis and Palmoplantar Pustulosis: Current Treatment and Future Prospects. Am J Clin Dermatol. 2016 Aug;17(4):349-58. doi: 10.1007/s40257-016-0191-7.

  PMID: 27113059 BACKGROUND

• Gold LS, Lebwohl MG, Sugarman JL, Pariser DM, Lin T, Martin G, Pillai R, Israel R, Ramakrishna T. Safety and efficacy of a fixed combination of halobetasol and tazarotene in the treatment of moderate-to-severe plaque psoriasis: Results of 2 phase 3 randomized controlled trials. J Am Acad Dermatol. 2018 Aug;79(2):287-293. doi: 10.1016/j.jaad.2018.03.040. Epub 2018 Apr 1.

  PMID: 29614243 BACKGROUND

• Sugarman JL, Weiss J, Tanghetti EA, Bagel J, Yamauchi PS, Stein Gold L, Lin T, Martin G, Pillai R, Israel R. Safety and Efficacy of a Fixed Combination Halobetasol and Tazarotene Lotion in the Treatment of Moderate-to-Severe Plaque Psoriasis: A Pooled Analysis of Two Phase 3 Studies. J Drugs Dermatol. 2018 Aug 1;17(8):855-861.

  PMID: 30124724 BACKGROUND

• Gottlieb A, Sullivan J, van Doorn M, Kubanov A, You R, Parneix A, Hugot S, Milutinovic M. Secukinumab shows significant efficacy in palmoplantar psoriasis: Results from GESTURE, a randomized controlled trial. J Am Acad Dermatol. 2017 Jan;76(1):70-80. doi: 10.1016/j.jaad.2016.07.058. Epub 2016 Oct 1.

  PMID: 27707593 BACKGROUND

• Finlay AY, Khan GK. Dermatology Life Quality Index (DLQI)--a simple practical measure for routine clinical use. Clin Exp Dermatol. 1994 May;19(3):210-6. doi: 10.1111/j.1365-2230.1994.tb01167.x.

  PMID: 8033378 BACKGROUND

MeSH Terms

Conditions

Psoriasis; Plaque, Amyloid

Interventions

halobetasol; tazarotene

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Hassan Hamade
• Organization: Icahn School of Medicine at Mount Sinai

hassan.hamade@mountsinai.org

212-844-8811

Study Officials

• Alice Gottlieb, MD, PhD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: January 19, 2021
• First Posted: January 22, 2021
• Study Start: November 19, 2020
• Primary Completion: March 29, 2022
• Study Completion: March 29, 2022
• Last Updated: October 27, 2023
• Results First Posted: October 27, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)