Status:
COMPLETED
Combination of Halobetasol Propionate and Tazarotene Lotion (Duobrii®) for Palmoplantar Plaque Type Psoriasis
Lead Sponsor:
Icahn School of Medicine at Mount Sinai
Collaborating Sponsors:
Bausch Health Americas, Inc.
Conditions:
Palmoplantar Psoriasis
Plaque Psoriasis
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 sol...
Eligibility Criteria
Inclusion
- 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:
- 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.
- 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.
Exclusion
Key Trial Info
Start Date :
November 19 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 29 2022
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT04720105
Start Date
November 19 2020
End Date
March 29 2022
Last Update
October 27 2023
Active Locations (1)
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1
Mount Sinai Downtown Union Square
New York, New York, United States, 10003