Bioequivalence Study of Two Treatments for the Treatment of Plaque Psoriasis

NCT ID: NCT05763082

Last Updated: 2024-08-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 414 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-07
• Study Completion Date: 2023-08-08

Brief Summary

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

Conditions

Plaque Psoriasis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Padagis active product

Group Type: EXPERIMENTAL

roflumilast cream 0.3%

Intervention Type: DRUG

test product

Reference product

Group Type: ACTIVE_COMPARATOR

Zoryve

Intervention Type: DRUG

Reference Listed Drug product

Padagis placebo product

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

placebo

Interventions

roflumilast cream 0.3%

test product

Intervention Type: DRUG

Zoryve

Reference Listed Drug product

Intervention Type: DRUG

Placebo

placebo

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Padagis LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

DS Research

Louisville, Kentucky, United States

Countries

United States

Other Identifiers

PAD-NY-22-05

Identifier Type: -

Identifier Source: org_study_id