A Demonstration of the Hair and Scalp Benefits of Duobrii in Scalp Psoriasis

NCT05872256 | Completed Phase 4 FDA Drug

• 1 other identifier: DCS-165-22
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The objectives of this research are to demonstrate the following:1. To demonstrate improvement in hair growth and hair appearance following 12 weeks of once daily treatment with tazarotene/halobetasol lotion in patients with moderate to severe scalp psoriasis.2. To demonstrate improvement in scalp itch reduction following 12 weeks of once daily treatment with tazarotene/halobetasol lotion in patients with moderate to severe scalp psoriasis.3. To pictorially demonstrate improvement in moderate to severe scalp psoriasis with 12 weeks of once daily treatment with tazarotene/halobetasol lotion.4. To assessment patient perceptions of the value of a lotion in the treatment of moderate to severe scalp psoriasis.

Conditions

Scalp Psoriasis

Outcome Measures

Primary Outcomes (2)

• Hair Growth

  Improvement in hair growth due to scalp psoriasis treatment

  12 weeks

• Scalp Itch

  Reduction in scalp itch due to scalp psoriasis treatment

  12 weeks

Study Arms (1)

Active Arm

OTHER

0.045% Tazarotene/0.01% Habetasol Lotion apply once daily at bedtime to the scalp afflicted with psoriasis

Drug: 0.045% Tazarotene/0.01% Halobetasol Lotion

Interventions

0.045% Tazarotene/0.01% Halobetasol Lotion DRUG

FDA approved drug for psoriasis treatment

Also known as: Duobrii Lotion

Active Arm

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. 2. Plaque type moderate to severe scalp psoriasis suitable for topical treatment.
• \. 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 pustular or erythrodermic psoriasis. 3. 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. 6. Subjects using any type of lotion, medication, or other topical product to the scalp psoriasis within 2 weeks of study entry.

Sponsors & Collaborators

• Dermatology Consulting Services, PLLC: lead
• Ortho Dermatologics: collaborator

Study Sites (1)

Dermatology Consulting Services, PLLC

High Point, North Carolina, 27262, United States

Location

Study Officials

• Zoe D Draelos, MD

  Dermatology Consulting Services, PLLC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Masking Details: All subjects will receive Duobrii lotion for scalp application to all areas afflicted with scalp psoriasis.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Model Details: All subjects will receive the currently marketed and FDA approved Duobrii lotion to the scalp for the treatment of scalp psoriasis.

Study Record Dates

• First Submitted: May 14, 2023
• First Posted: May 24, 2023
• Study Start: June 1, 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)