Extensive Psoriasis Vulgaris MedDRA version: 20.0 Level: LLT Classification code 10050576 Term: Psoriasis vulgaris System Organ Class: 100000004858
Conditions
Interventions
Product Name: MC2-01 cream
Pharmaceutical Form: Cream
INN or Proposed INN: Calcipotriol
CAS Number: 112965-21-6
Other descriptive name: CALCIPOTRIOL, ANHYDROUS
Concentration unit: µg microgram(s)
Conc
Sponsors
MC2 Therapeutics Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: The parent(s), or legal guardian(s)have provided written informed consent. The subject has provided written assent to the trial. Healthy males or non-pregnant females, who are between 12 to 16 years, 11-month-old. Clinical diagnosis of plaque psoriasis (psoriasis vulgaris) of at least 6 months, with or without scalp Treatment area between 10% and 30% of the BSA on the body and scalp At least moderate severity on the treatment area Normal HPA axis function Serum albumin-corrected calcium below the upper reference limit at SV2 Negative urine pregnancy test for WOCP and use of a highly effective method of contraception Are the trial subjects under 18? yes Number of subjects for this age range: 30 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Unstable forms of psoriasis Other inflammatory skin disease in the treatment area Presence of pigmentation or extensive scarring in the treatment area Use of phototherapy within 4 weeks prior to inclusion Current or past history of disorders of calcium metabolism Oral calcium supplements, vitamin D supplements, bisphosphonates or calcitonin Strong systemic cytochrome P450 3A4 (CYP 3A4) inhibitors and inducers Use of topical treatments for Psoriasis 2 weeks prior to inclusion Systemic treatment with biological therapies for Psoriasis Use of systemic medication that suppresses the immune system Use of life vaccines Known allergic asthma or serious allergies Skin infections Known human immunodeficiency virus (HIV) infection Known or suspected of hypersensitivity to any component of the test product or reference product Any chronic or acute medical condition that, in the opinion of the investigator, may pose a risk to the safety of the subject Females who are pregnant, breast feeding, or planning a pregnancy Participation in another clinical trial or received an IP or non-marketed drug substance within 30 days Previously enrolled in this trial Subject is unlikely to comply with the clinical trial protocol in the opinion of the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the effect of MC2-01 cream on the HPA axis and calcium metabolism following once daily topical application under maximum-use conditions in subjects with extensive psoriasis vulgaris.;Secondary Objective: To evaluate the pharmacokinetic profile of the active ingredients and their main metabolites following once daily topical application of MC2-01 cream under maximum-use conditions in adolescent subjects (age 12 to 16 years, 11 months) with extensive psoriasis vulgaris.;Primary end point(s): HPA axis: The assessment of HPA axis suppression and of changes in calcium metabolism are the primary endpoints in this trial.;Timepoint(s) of evaluation of this end point: Week 4 and Week 8 of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Plasma PK parameters Adverse Events ;Timepoint(s) of evaluation of this end point: Plasma PK: week 4 of treatment Adverse Events: after treatment has finished | — |
Countries
Czech Republic, Germany, Hungary
Contacts
Public ContactAnnika Michaelis
proinnovera GmbH
Outcome results
None listed