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A Maximal Use Trial Evaluating the Pharmacokinetic Profile of MC2-01 Cream | Clinical Trials | Clareo Health

COMPLETEDPHASE2

A Maximal Use Trial Evaluating the Pharmacokinetic Profile of MC2-01 Cream

A Randomised, Open-label, Maximal Use Trial, Evaluating the Pharmacokinetic Profile of Active Ingredients and Their Metabolites After Application of MC2-01 Cream Compared With Active Comparator in Subjects With Extensive Psoriasis Vulgaris

NCT03462927•MC2 Therapeutics

View on ClinicalTrials.gov

Summary

This is a phase 2, randomised, open-label, parallel-group, multicentre trial in which MC2-01 cream and calcipotriene \[CAL\]/betamethasone \[BDP\] ointment (comparator) is investigated in subjects with clinically diagnosed extensive psoriasis vulgaris.

Detailed Description

The MC2-01 cream is designed for optimal patient satisfaction - it quickly absorbs into the skin leaving it nicely moisturized allowing patients to move on with daily routines. In this trial, the MC2-01 cream will be compared to a marketed calcipotriene \[CAL\]/betamethasone dipropionate \[BDP\] ointment. The purpose of the trial, is to determine the pharmacokinetic parameters of MC2-01 cream and the comparator under maximum use conditions.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Have provided written informed consent.
•Generally healthy males or non-pregnant females, of any race or ethnicity, who are at least 18 years of age at the time of screening.
•At Visit 1/Day 0, have a clinical diagnosis of plaque psoriasis (psoriasis vulgaris) of at least 6 months duration involving scalp and body (trunk and/or limbs) that is amenable to topical treatment with a maximum of 100 g of trial medication per week.
•Have a Physician's Global Assessment \[PGA\] of severity of at least moderate on the trunk, limbs and/or scalp, at Visit 1/Day 0.
•Have a treatment area between 20% and 30% of the body surface area \[BSA\] on the trunk, limbs and/or scalp, excluding psoriatic lesions on the face, genitals, and intertriginous areas, at Visit 1/Day 0.

Exclusion Criteria

•Current diagnosis of unstable forms of psoriasis
•Other inflammatory skin disease in the treatment area
•Pigmentation, extensive scarring, pigmented lesions or sunburn in the treatment areas
•Planned exposure to natural or artificial sunlight
•Phototherapy and ultraviolet B radiation within 4 weeks prior to Visit 1/Baseline and during the trial;
•Current or past history of hypercalcemia, vitamin D toxicity, severe renal insufficiency, or severe hepatic disorders;
•Oral calcium supplements, vitamin D supplements, bisphosphonates or calcitonin within 4 weeks prior to Visit 1/Day 0 during the trial period.
•Planned initiation of, or changes to concomitant medication that could affect calcium metabolism during the trial;
•Planned initiation of, or changes to, concomitant estrogen therapy during the trial;
•Strong systemic cytochrome P450 3A4 (CYP 3A4) inhibitors within 4 weeks prior to Vist 1/Day 0 and during the trial period;
+9 more criteria

Locations (1)

Lenus Research and Medical Group

Sweetwater, Florida, United States

Key Dates

Start Date

February 8, 2018

Primary Completion Date

August 4, 2018

Completion Date

August 4, 2018

Last Updated

December 24, 2019

Enrollment

ACTUAL participants

Conditions

Psoriasis Vulgaris

Interventions

MC2-01 Cream

DRUG

CAL/BDP combination

DRUG

Therapeutic Drug Monitoring of Brodalumab in Psoriasis Patients (BIOLOPTIM-BRO)

NCT04080635

Psoriasis Vulgaris

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COMPLETEDPHASE4

Dose Reduction of IL17 and IL23 Inhibitors in Psoriasis

NCT04340076

PsoriasisPsoriasis Vulgaris

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WITHDRAWNNA

Safety and Effectiveness of Combined LED Light for the Treatment of Mild to Moderate Plaque Type Psoriasis Vulgaris

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 24, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Maximal Use Trial Evaluating the Pharmacokinetic Profile of MC2-01 Cream

Inclusion Criteria

Exclusion Criteria

Therapeutic Drug Monitoring of Brodalumab in Psoriasis Patients (BIOLOPTIM-BRO)

Dose Reduction of IL17 and IL23 Inhibitors in Psoriasis

Safety and Effectiveness of Combined LED Light for the Treatment of Mild to Moderate Plaque Type Psoriasis Vulgaris

Special Drug Use-results Survey to Evaluate Safety and Efficacy of Cosentyx in Pediatric Patients With PsV, PsA, or GPP

A Pilot Study to Explore the Role of Gut Flora in Psoriasis

The Mediterranean Diet and Time-Restricted Eating Dietary Interventions for Psoriasis Study