Anti-Inflammatory Effects of 0.045% Tazarotene/0.01% Halobetasol Lotion in Psoriasis

NCT06042647 | Completed Phase 4 FDA Drug

• 1 other identifier: DCS-69-22
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this research is to demonstrate superior anti-inflammatory effects, as demonstrated by a reduction in TNF-a and IL-17A, with tazarotene/halobetasol lotion in patients with mild to moderate plaque type psoriasis as compared to clobetasol propionate 0.05% cream.

Conditions

Psoriasis Vulgaris

Outcome Measures

Primary Outcomes (1)

• Concentration of TNF-a and IL-17A in Psoriatic Plaques

  The primary outcome is to compare the concentration of TNF-a and/or IL-17A after discontinuing treatment for 4 weeks with tazarotene/halobetasol lotion as compared to clobetasol propionate 0.05% cream.

  8 weeks

Study Arms (2)

0.01% Halobetasol and 0.045% Tazarotene Lotion

ACTIVE COMPARATOR

0.01% Halobetasol and 0.045% Tazarotene Lotion (Duobrii)Applied to designated target plaque at bedtime.

Drug: 0.01% Halobetasol; Drug: 0.045% Tazarotene

Clobetasol Propionate 0.05% Cream (generic)

ACTIVE COMPARATOR

Clobetasol Propionate 0.05% Cream (generic)Applied to designated target plaque at bedtime.

Drug: 0.05% Clobetasol Propionate

Interventions

0.01% Halobetasol DRUG

Drug to be applied at bedtime to designated target psoriasis plaque at bedtime.

0.01% Halobetasol and 0.045% Tazarotene Lotion

0.045% Tazarotene DRUG

Drug to be applied in combination with 0.01% Halobetasol to the designated psoriasis plaque at bedtime.

0.01% Halobetasol and 0.045% Tazarotene Lotion

0.05% Clobetasol Propionate DRUG

Drug to be applied to designated psoriatic plaque at bedtime.

Clobetasol Propionate 0.05% Cream (generic)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males or non-pregnant females 18+ years of age.
• Plaque type mild to moderate psoriasis suitable for topical treatment.
• The presence of 2 plaques suitable for tape stripping
• Subjects must be willing to allow a series of tape pieces to be pressed and removed from 2 target psoriasis plaques.
• Subjects must be in general good health as determined from a medical history.
• Subjects must read and sign the informed consent form after the nature of the study has been fully explained.

You may not qualify if:

• Subjects with known allergies or sensitivities to ingredients contained in the test products.
• Subjects with an allergy to latex or adhesives.
• Subjects with pustular or erythrodermic psoriasis.
• Subjects who are pregnant or nursing or planning to become pregnant during the course of the study.
• Subjects who are currently participating in any other clinical study (i.e., dermal patch, use tests, investigational drug or devices, etc.).
• Subjects viewed by the investigator as not being able to complete the study.
• Subjects using any type of lotion, medication, or other topical product to the psoriasis plaques.

Sponsors & Collaborators

• Dermatology Consulting Services, PLLC: lead

Study Sites (1)

Dermatology Consulting Services, PLLC

High Point, North Carolina, 27262, United States

Location

MeSH Terms

Interventions

halobetasol; tazarotene; Clobetasol

Intervention Hierarchy (Ancestors)

Betamethasone; Steroids, Fluorinated; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Investigator will not know which product is applied to the right and left psoriasis target plaque.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Model Details: One product applied to psoriasis on the right side of the body and a second product applied to the left side of the body. The right and left side product applications will be randomized.

Study Record Dates

• First Submitted: September 6, 2023
• First Posted: September 18, 2023
• Study Start: July 13, 2023
• Primary Completion: November 13, 2023
• Study Completion: November 13, 2023
• Last Updated: November 18, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)