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

October 25, 2023 updated by: Alice B Gottlieb, Icahn School of Medicine at Mount Sinai

Investigator-Initiated, Open Label Trial of a Combination of Halobetasol Propionate 0.01% Andtazarotene 0.045% Lotion (Duobrii®) for Plaque Type Psoriasis of the Hands and/or Feet

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Plaque type psoriasis of the hands and/or feet affects approximately 3-4% of patients with psoriasis. It is characterized by well-defined erythematous desquamative plaques located on the palms and soles, which may be limited to acral involvement or occur in combination with generalized psoriasis. Psoriasis that affects the hands and/or feet has a profound impact on quality of life (QoL) as it contributes to more physical disability and discomfort than patients with other forms of psoriasis, such as difficulty walking or using the hands.

Furthermore, psoriasis of the hands and/or feet is generally considered a therapeutic challenge because the thicker stratum corneum reduces the penetration of topical treatment agents. Systemic treatments (retinoids, psoralen-ultraviolet A [PUVA], methotrexate, cyclosporine, and biologic therapy) have shown limited efficacy on psoriasis in acral areas. Unfortunately, patients with hand and/or foot involvement often have too low of body surface area (BSA) to participate in clinical trials for new psoriasis treatments, resulting in limited studies among this sub-population and no clear treatment algorithm.

The high unmet need for an effective treatment for psoriasis of the hands and/or feet has been addressed in recent years with the development of new medications for generalized psoriasis that may also be effective in treating disease localized to acral areas. In 2015, two multicenter, double-blind, randomized, parallel-group phase 3 studies were conducted to assess the safety, tolerability, and efficacy of lotion containing a combination of halobetasol propionate 0.01% and tazarotene 0.045% (HP/TAZ). The study population was subjects with moderate-to-severe psoriasis. The study results found that treatment success (defined as at least a 2-grade improvement from baseline Investigator Global Assessment score and a score of clear or almost clear) was achieved in around 40% of subjects by week 8, with substantial reductions in affected BSA, improvement in QoL, and a significant reduction in signs and symptoms of psoriasis.

These phase 3 studies did not include a sub-analysis of the effect of HP/TAZ on psoriasis of the hands and/or feet. Given that topical steroids and topical retinoids are separately recommended as treatment options for psoriasis of the hands and/or feet, an agent that safely combines these medications - and that has demonstrated safety and efficacy in generalized psoriasis - offers a potential treatment for psoriasis of the hands and/or feet.

The purpose of the study described in this protocol is to evaluate the effect of HP/TAZ on plaque type psoriasis of the hands and/or feet after 24 weeks of daily treatment. In addition, given the impact of this variant of psoriasis on QoL and the relative lack of currently available treatment options, this study will also evaluate the impact of HP/TAZ treatment on patient-reported QoL measures and treatment satisfaction scoring.

Study Type

Interventional

Enrollment (Actual)

22

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10003
        • Mount Sinai Downtown Union Square

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria

  • 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:

    1. 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

    2. 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.

      OR

    3. Option 3: Abstinence from sex when it is a lifestyle choice, and not just a social circumstance.

Exclusion Criteria

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Participants with plaque type psoriasis
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®
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.
Other Names:
  • Halobetasol propionate 0.01%/tazarotene 0.045% lotion
  • HP/TAZ

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Palmoplantar Physician Global Assessment (ppPGA)
Time Frame: Baseline and Week 24
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dermatology Quality of Life Index (DLQI)
Time Frame: Baseline and Week 24
Patient-reported outcomes evaluated by Dermatology Quality of Life Index (DLQI). DLQi is a 10-item questionnaire, each question is scored from 0 to 3, giving a possible score range from 0 (meaning no impact of skin disease on quality of life) to 30 (meaning maximum impact on quality of life). Higher score indicates poorer health outcome.
Baseline and Week 24
Numerical Rating Scale (NRS)
Time Frame: Baseline and Week 24
Treatment satisfaction evaluated by a Numerical Rating Scale (NRS). Full scale from 0 to 10, higher score indicates poorer health outcome.
Baseline and Week 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Icahn School of Medicine at Mount Sinai

Collaborators

Bausch Health Americas, Inc.

Investigators

  • Principal Investigator: Alice Gottlieb, MD, PhD, Icahn School of Medicine at Mount Sinai

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 19, 2020

Primary Completion (Actual)

March 29, 2022

Study Completion (Actual)

March 29, 2022

Study Registration Dates

First Submitted

January 19, 2021

First Submitted That Met QC Criteria

January 19, 2021

First Posted (Actual)

January 22, 2021

Study Record Updates

Last Update Posted (Actual)

October 27, 2023

Last Update Submitted That Met QC Criteria

October 25, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GCO 20-0608

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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