Clinical trial NCT04720105: Combination of Halobetasol Propionate and Tazarotene Lotion (Duobrii®) for Palmoplantar Plaque Type Psoriasis
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Palmoplantar Psoriasis
Plaque Psoriasis
Keywords: Palmoplantar
Psoriasis
Plaque
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
Collaborators: name: Bausch Health Americas, Inc.
First posted: 2021-01-22
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Eligibility 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.

Primary outcomes:
measure: Palmoplantar Physician Global Assessment (ppPGA)
timeFrame: Baseline and Week 24
Secondary outcomes:
measure: Dermatology Quality of Life Index (DLQI)
timeFrame: Baseline and Week 24
measure: Numerical Rating Scale (NRS)
timeFrame: Baseline and Week 24
Other outcomes:
Locations:
city: New York
country: United States
facility: Mount Sinai Downtown Union Square
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Alice Gottlieb, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.