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

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ClinicalTrials.gov Identifier: NCT04720105
Recruitment Status : Recruiting
First Posted : January 22, 2021
Last Update Posted : April 20, 2021
Sponsor:
Collaborator:
Bausch Health Americas, Inc.
Information provided by (Responsible Party):
Alice B Gottlieb, Icahn School of Medicine at Mount Sinai

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.

Condition or disease Intervention/treatment Phase
Palmoplantar Psoriasis Plaque Psoriasis Drug: Duobrii® Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 22 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : November 19, 2020
Estimated Primary Completion Date : November 2021
Estimated Study Completion Date : November 2021

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Palmoplantar Physician Global Assessment (ppPGA) [ Time Frame: 24 weeks ]
    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)


Secondary Outcome Measures :
  1. Dermatology Quality of Life Index (DLQI) [ Time Frame: 24 weeks ]
    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.

  2. Numerical Rating Scale (NRS) [ Time Frame: 24 weeks ]
    Treatment satisfaction evaluated by a Numerical Rating Scale (NRS). Full scale from 0 to 10, higher score indicates poorer health outcome.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04720105


Contacts
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Contact: Alice Gottlieb, MD, PhD 212-844-8800 Alice.Gottlieb@mountsinai.org

Locations
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United States, New York
Mount Sinai Downtown Union Square Recruiting
New York, New York, United States, 10003
Sponsors and Collaborators
Icahn School of Medicine at Mount Sinai
Bausch Health Americas, Inc.
Investigators
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Principal Investigator: Alice Gottlieb, MD, PhD Icahn School of Medicine at Mount Sinai
Publications:

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Responsible Party: Alice B Gottlieb, Clinical Professor, Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT04720105    
Other Study ID Numbers: GCO 20-0608
First Posted: January 22, 2021    Key Record Dates
Last Update Posted: April 20, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Alice B Gottlieb, Icahn School of Medicine at Mount Sinai:
Palmoplantar
Psoriasis
Plaque
Additional relevant MeSH terms:
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Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Halobetasol
Tazarotene
Dermatologic Agents
Keratolytic Agents
Vasoconstrictor Agents