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

NCT03819218 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2021-03-19

Study results available
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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.

Conditions

  • Psoriasis Vulgaris

Interventions

DRUG

MC2-01 cream

MC2-01 cream (Calcipotriene/betamethasone dipropionate, w/w 0.005%/ 0.064%)

Sponsors & Collaborators

  • MC2 Therapeutics

    lead INDUSTRY

Principal Investigators

  • Andreas Pinter, MD · Dept. of Dermatology, Venereology and Allergology

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
12 Years
Max Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-27
Primary Completion
2020-12-11
Completion
2020-12-11
FDA Drug
Yes

Countries

  • Czechia
  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03819218 on ClinicalTrials.gov