Trial Outcomes & Findings for Combination of Halobetasol Propionate and Tazarotene Lotion (Duobrii®) for Palmoplantar Plaque Type Psoriasis (NCT NCT04720105)

NCT ID: NCT04720105

Last Updated: 2023-10-27

Results Overview

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)

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

22 participants

Primary outcome timeframe

Baseline and Week 24

Results posted on

2023-10-27

Participant Flow

Participant milestones

Participant milestones
Measure	Participants With Plaque Type Psoriasis Participants with plaque type psoriasis to be treated with Duobrii® (halobetasol propionate 0.01%/tazarotene 0.045% lotion, HP/TAZ) to be applied thinly once a day on the affected areas of hands and/or feet at weeks 0,2,8,16 for a total of 24 weeks.
Overall Study STARTED	22
Overall Study COMPLETED	17
Overall Study NOT COMPLETED	5

Reasons for withdrawal

Reasons for withdrawal
Measure	Participants With Plaque Type Psoriasis Participants with plaque type psoriasis to be treated with Duobrii® (halobetasol propionate 0.01%/tazarotene 0.045% lotion, HP/TAZ) to be applied thinly once a day on the affected areas of hands and/or feet at weeks 0,2,8,16 for a total of 24 weeks.
Overall Study Lack of Efficacy	1
Overall Study Lost to Follow-up	1
Overall Study Withdrawal by Subject	3

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Participants With Plaque Type Psoriasis n=22 Participants Participants with plaque type psoriasis to be treated with Duobrii® (halobetasol propionate 0.01%/tazarotene 0.045% lotion, HP/TAZ) to be applied thinly once a day on the affected areas of hands and/or feet at weeks 0,2,8,16 for a total of 24 weeks.
Age, Continuous	52.4 years STANDARD_DEVIATION 12.0 • n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	22 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	4 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	8 Participants n=5 Participants
Race (NIH/OMB) White	10 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and Week 24

Population: For week 24 data, results reported for the patients who had completed study

Outcome measures

Outcome measures
Measure	Participants With Plaque Type Psoriasis n=22 Participants Participants with plaque type psoriasis to be treated with Duobrii® (halobetasol propionate 0.01%/tazarotene 0.045% lotion, HP/TAZ) to be applied thinly once a day on the affected areas of hands and/or feet at weeks 0,2,8,16 for a total of 24 weeks.
Palmoplantar Physician Global Assessment (ppPGA) Baseline	3.47 score on a scale Standard Deviation 0.72
Palmoplantar Physician Global Assessment (ppPGA) Week 24	2.24 score on a scale Standard Deviation 1.03

SECONDARY outcome

Timeframe: Baseline and Week 24

Population: For week 24 data, results reported for the patients who had completed study

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.

Outcome measures

Outcome measures
Measure	Participants With Plaque Type Psoriasis n=22 Participants Participants with plaque type psoriasis to be treated with Duobrii® (halobetasol propionate 0.01%/tazarotene 0.045% lotion, HP/TAZ) to be applied thinly once a day on the affected areas of hands and/or feet at weeks 0,2,8,16 for a total of 24 weeks.
Dermatology Quality of Life Index (DLQI) Baseline	6.24 score on a scale Standard Deviation 5.83
Dermatology Quality of Life Index (DLQI) Week 24	4.94 score on a scale Standard Deviation 5.58

SECONDARY outcome

Timeframe: Baseline and Week 24

Population: For week 24 data, results reported for the patients who had completed study

Treatment satisfaction evaluated by a Numerical Rating Scale (NRS). Full scale from 0 to 10, higher score indicates poorer health outcome.

Outcome measures

Outcome measures
Measure	Participants With Plaque Type Psoriasis n=22 Participants Participants with plaque type psoriasis to be treated with Duobrii® (halobetasol propionate 0.01%/tazarotene 0.045% lotion, HP/TAZ) to be applied thinly once a day on the affected areas of hands and/or feet at weeks 0,2,8,16 for a total of 24 weeks.
Numerical Rating Scale (NRS) Baseline	1.35 score on a scale Standard Deviation 2.18
Numerical Rating Scale (NRS) Week 24	1.29 score on a scale Standard Deviation 2.05

Adverse Events

Participants With Plaque Type Psoriasis

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Hassan Hamade

Icahn School of Medicine at Mount Sinai

Phone: 212-844-8811

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place