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Phase 4 N=22 Treatment

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

Palmoplantar Psoriasis · Plaque Psoriasis

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

OutcomeResultp-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.
View full record on ClinicalTrials.gov →

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.

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