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

• Status: Recruiting
• Trial end date: 2021-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Icahn School of Medicine at Mount Sinai
• Collaborator: Bausch Health Americas, Inc.
• Treatments: Halobetasol; Tazarotene

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.