Phase 4
N=22
Combination of Halobetasol Propionate and Tazarotene Lotion (Duobrii®) for Palmoplantar Plaque Type Psoriasis
Palmoplantar Psoriasis · Plaque Psoriasis
Bottom Line
View on ClinicalTrials.gov: NCT04720105 ↗Enrolled (actual)
22
Serious AEs
0.0%
Results posted
Oct 2023
Primary outcome: Primary: Palmoplantar Physician Global Assessment (ppPGA) — 3.47; 2.24 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Duobrii® (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Icahn School of Medicine at Mount Sinai
- Primary completion
- Mar 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Palmoplantar Physician Global Assessment (ppPGA) |
3.47; 2.24 | — |
| SECONDARY Dermatology Quality of Life Index (DLQI) |
6.24; 4.94 | — |
| SECONDARY Numerical Rating Scale (NRS) |
1.35; 1.29 | — |
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.
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:
- 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.
Data sourced from ClinicalTrials.gov (NCT04720105). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.