NCT03819218

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

A Multicentre, Open-label, Single-group Maximal Use Trial, Evaluating the Safety and Pharmacokinetic Profile of the Active Ingredients and Their Metabolites After Application of MC2-01 Cream in Adolescents With Extensive Psoriasis Vulgaris

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: MC2 Therapeutics · Industry
• Sex: All
• Age: 12 Years – 16 Years
• Healthy volunteers: Not accepted

Summary

This is a phase 2, open-label, single-group, multicentre trial in which the investigational product, MC2-01 cream, is investigated in adolescent subjects (age 12 to 16 years, 11 months) 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, subjects who fulfil all inclusion and exclusion criteria are enrolled in the trial and will apply one dose of trial medication topically once daily for 8 weeks. The purpose of the trial, is to determine the and pharmacokinetic parameters of MC2-01 cream in adolescent subjects under maximum use conditions.

Conditions

• Psoriasis Vulgaris

Interventions

Type	Name	Description
DRUG	MC2-01 cream	MC2-01 cream (Calcipotriene/betamethasone dipropionate, w/w 0.005%/ 0.064%)

Timeline

• Start date: 2018-12-27
• Primary completion: 2020-12-11
• Completion: 2020-12-11
• First posted: 2019-01-28
• Last updated: 2021-03-19
• Results posted: 2021-02-21

Locations

2 sites across 2 countries: Czechia, Germany

Regulatory

• FDA-regulated drug study