Bioequivalence Study of Two Treatments for the Treatment of Plaque Psoriasis

Plaque Psoriasis Clinical Trial

Official title:

Multi-Center, Double-Blind, Randomized, Vehicle-Controlled, Parallel-Group Study to Compare Padagis' Roflumilast Cream 0.3% to Arcutis's Zoryve™ (Roflumilast Cream 0.3%) Cream and Both Active Treatments to a Vehicle Control in the Treatment of Plaque Psoriasis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05763082
• Other study ID #: PAD-NY-22-05
• Status: Completed
• Phase: Phase 3
• Start date: February 7, 2023
• Est. completion date: August 8, 2023

Study information

• Verified date: September 2023
• Source: Padagis LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To compare the safety and efficacy of Padagis' product to an FDA approved product for the treatment of plaque psoriasis

Recruitment information / eligibility

• Status: Completed
• Enrollment: 414
• Est. completion date: August 8, 2023
• Est. primary completion date: August 8, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Signed IRB approved written informed consent/assent

2. 12 to 75 years of age, inclusive.

3. Subjects must have a clinical diagnosis of stable symptomatic plaque psoriasis.

4. Baseline Investigator's Global Assessment Score of 3 (moderate).

5. Subjects must have a Body Surface Area (BSA) between 2% to 20%

6. Females of child bearing potential (excluding women who are surgically sterilized (tubal ligation or bilateral oophorectomy or hysterectomy) or post-menopausal for at least 2 years), in addition to having a negative urine pregnancy test at Visit 1/Day1(Baseline), must be willing to use an acceptable form of birth control during the study.

Exclusion Criteria:

1. Pregnant, breastfeeding or planning a pregnancy within the period of their study participation period.

2. Current diagnosis of unstable forms of psoriasis in the treatment area.

3. History of unresponsiveness to topical treatment for psoriasis

4. Presence of any other skin condition that, in the Investigator's opinion, might interfere with psoriasis diagnosis and/or evaluations

5. Any uncontrolled, chronic or serious disease or medical condition that would prevent participation in a clinical trial, or, in judgment of the investigator, would put the subject at undue risk or might confound the study assessments

6. Use of medicated make-up throughout the study and significant change in the use of consumer products within 30 days (1 month) of study entry and throughout the study

7. Subject consumes excessive alcohol, abuses drugs, or has a condition that could compromise the subject's ability to comply with study requirements.

8. Subjects who in the opinion of the investigator, are unlikely to be able to follow the restrictions of the protocol and complete the study

Related Conditions & MeSH terms

• Plaque Psoriasis
• Psoriasis

Intervention

Drug:
• roflumilast cream 0.3%
test product
• Zoryve
RLD product
• Placebo
placebo

Locations

Country	Name	City	State
United States	DS Research	Louisville	Kentucky

Sponsors (1)

Lead Sponsor	Collaborator
Padagis LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Investigator's Global Assessment (IGA)	percentage of subjects at Day 56 who achieve Treatment Success, which is defined as an IGA score of None (0) or Minimal (1) with a 2-grade improvement from Day 1	Day 1 to Day 56