Palmoplantar PsoriasisPhase 4NCT04720105
Combination of Halobetasol Propionate and Tazarotene Lotion (Duobrii®) for Palmoplantar Plaque Type Psoriasis
A Phase 4 study testing Duobrii® in people with Palmoplantar Psoriasis and Plaque Psoriasis, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Palmoplantar Psoriasis, Plaque Psoriasis
- What is being tested?
- Duobrii®
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Nov 2020to 29 Mar 2022
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
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- 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.
- OR
- Option 3: Abstinence from sex when it is a lifestyle choice, and not just a social circumstance.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Mount Sinai Downtown Union Square
New York, New York, 10003
About this study
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
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.
Read the 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.
- Conditions
- Palmoplantar Psoriasis, Plaque Psoriasis
- Being tested
- Duobrii®
- Keywords
- Palmoplantar, Psoriasis, Plaque
- Medical subject headings
- Psoriasis, Plaque, Amyloid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Duobrii®Drug
Also called Halobetasol propionate 0.01%/tazarotene 0.045% lotion, HP/TAZ
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Duobrii® |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Baseline and Week 24
Secondary outcomes (2)
Dermatology Quality of Life Index (DLQI)
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.
Measured: Baseline and Week 24
Numerical Rating Scale (NRS)
Treatment satisfaction evaluated by a Numerical Rating Scale (NRS). Full scale from 0 to 10, higher score indicates poorer health outcome.
Measured: Baseline and Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2021
- Study start19 Nov 2020
- Primary completion29 Mar 2022
- Study completion29 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Palmoplantar PsoriasisStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Collaborators
- Bausch Health Americas, Inc.
- Responsible party
- Principal investigator, Alice B Gottlieb, Icahn School of Medicine at Mount Sinai
- Investigators
- Alice Gottlieb, MD, PhD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04720105
- Sponsor's protocol ID
- GCO 20-0608
- Status last verified
- Oct 2023
- First submitted
- 19 Jan 2021
- Last updated
- 27 Oct 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 27938808Raposo 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.
PubMed 27113059Gold 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.
PubMed 29614243Sugarman 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.
PubMed 30124724Gottlieb 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.
PubMed 27707593Finlay 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.
PubMed 8033378