Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03819218
Recruitment Status : Recruiting
First Posted : January 28, 2019
Last Update Posted : January 28, 2019
Sponsor:
Information provided by (Responsible Party):
Drug Delivery Solutions Ltd. (part of MC2 Therapeutics)

Brief 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.

Condition or disease Intervention/treatment Phase
Psoriasis Vulgaris Drug: MC2-01 cream Phase 2

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : December 27, 2018
Estimated Primary Completion Date : July 17, 2020
Estimated Study Completion Date : July 17, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Arm Intervention/treatment
Experimental: MC2-01 cream
MC2-01 (calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%) cream. One application daily for 8 weeks
Drug: MC2-01 cream
MC2-01 cream (Calcipotriene/betamethasone dipropionate, w/w 0.005%/ 0.064%)




Primary Outcome Measures :
  1. Hypothalamic-pituitary-adrenal (HPA) axis [ Time Frame: Week 4 ]

    Adrenal function will be assessed in a challenge test with an intravenous dose of cosyntropin. Measurement of serum cortisol levels pre- and post- stimulation is an accepted standard method used to evaluate adrenal suppression.

    The test consists of an initial blood sampling. Following the blood sample, an intravenous bolus injection of 0.25 mg cosyntropin is given. The serum cortisol concentration 30 min. after will reflect stimulation of the adrenal glands induced by cosyntropin. HPA axis suppression is define as serum cortisol below 18 µg/dL


  2. Hypothalamic-pituitary-adrenal (HPA) axis [ Time Frame: Week 8 ]

    Adrenal function will be assessed in a challenge test with an intravenous dose of cosyntropin. Measurement of serum cortisol levels pre- and post- stimulation is an accepted standard method used to evaluate adrenal suppression.

    The test consists of an initial blood sampling. Following the blood sample, an intravenous bolus injection of 0.25 mg cosyntropin is given. The serum cortisol concentration 30 min. after will reflect stimulation of the adrenal glands induced by cosyntropin. HPA axis suppression is define as serum cortisol below 18 µg/dL


  3. Calcium metabolism [ Time Frame: Week 4 ]
    Changes from baseline in albumin-corrected S-calcium

  4. Calcium metabolism [ Time Frame: Week 8 ]
    Changes from baseline in albumin-corrected S-calcium

  5. Calcium metabolism [ Time Frame: Week 4 ]
    Changes from baseline in ratio of urine calcium to creatinine

  6. Calcium metabolism [ Time Frame: Week 8 ]
    Changes from baseline in ratio of urine calcium to creatinine


Secondary Outcome Measures :
  1. Pharmacokinetic parameters of active ingredients and their main metabolite [ Time Frame: Week 4 ]
    Area under the time-concentration curve from time zero to the last measurable concentration [AUC0-t]

  2. Pharmacokinetic parameters of active ingredients and their main metabolites [ Time Frame: Week 4 ]
    Area under the time-concentration curve from time zero to 5 hours [AUC0-5]

  3. Pharmacokinetic parameters of active ingredients and their main metabolites [ Time Frame: Week 4 ]
    Maximum Plasma Concentration [Cmax]

  4. Pharmacokinetic parameters of active ingredients and their main metabolites [ Time Frame: Week 4 ]
    Time to maximum plasma drug concentration [Tmax]



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   12 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • The parent(s), or legal guardian(s) (according to national law) have provided written informed consent following their receipt of verbal and written information about the trial
  • The subject (according to national law) has provided written assent to the trial following their receipt of verbal and written information about the trial
  • Generally healthy males or non-pregnant females, of any race or ethnicity, who are between 12 to 16 years, 11-month-old at Screening Visit 1 (SV1)
  • At Visit 1/Day 0, have a clinical diagnosis of plaque psoriasis (psoriasis vulgaris) of at least 6 months duration involving body (trunk and/or limbs), with or without scalp
  • Have a treatment area between 10% and 30% of the Body Surface Area (BSA) on the body (trunk and/or limbs) and scalp, excluding psoriatic lesions on the face, genitals, and intertrigenous areas, at Visit 1/Day 0
  • Have a Physician's Global Assessment (PGA) of at least moderate severity on the treatment area
  • A normal HPA axis function including a serum cortisol concentration above 4,5 mcg/dl before ACTH-challenge and equal or above 18 mcg/dl 30 minutes after ACTH challenge, at Screening Visit 2 (SV2)
  • A serum albumin-corrected calcium below the upper reference limit at SV2

Exclusion Criteria:

  • Have a current diagnosis of unstable forms of psoriasis, including erythrodermic or pustular psoriasis
  • Other inflammatory skin disease in the treatment area that may confound the evaluation of the psoriasis vulgaris
  • Presence of infections in the treatment area or skin manifestations or atrophic skin, atrophic striae, skin vein fragility, ichthyosis, acne vulgaris, acne rosacea, rosacea, ulcers and wounds in the treatment area
  • Presence of pigmentation, extensive scarring, pigmented lesions or sunburn in the treatment areas, which could interfere with the rating of efficacy parameters
  • Planned excessive or prolonged exposure to either natural or artificial sunlight
  • Use of phototherapy (psoralen + ultraviolet A radiation and ultraviolet B radiation within 4 weeks prior to SV2 and during the trial
  • Current or past history of disorders of calcium metabolism associated with 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 SV2
  • 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 or inducers within 4 weeks prior to SV2 and during the trial
  • Use of topical treatments, except for emollients and non-medicated shampoos, with a possible effect on psoriasis within 2 weeks prior to SV2 and during the trial
  • Systemic treatment with biological therapies, with a possible effect on psoriasis vulgaris within the following time period prior to SV2 and during the trial
  • Initiation of, or expected changes to, concomitant medication that may affect psoriasis during the trial
  • Any of the following conditions, whether known or suspected; Clinically diagnosed depression where the subject is in current treatment with medication approved for treatment of depression; Endocrine disorders known to affect cortisol levels or HPA axis integrity; Non-nocturnal sleep patterns
  • Use of systemic medication that suppresses the immune system and other systemic chemotherapeutic antineoplastic therapy within 4 weeks prior to the SV2 and during the trial
  • Use of live vaccines 4 weeks before SV2 and during the trial
  • Have clinical signs of skin infection with bacteria, viruses, or fungi
  • Known human immunodeficiency virus (HIV) infection, active hepatitis B or hepatitis C
  • Known or suspected of hypersensitivity to any component of the test product
  • Known allergic asthma, serious allergies or allergies where recurrent acute or chronic treatment is necessary
  • Have any chronic or acute medical condition that, in the opinion of the investigator, may pose a risk to the safety of the subject, or may interfere with the assessment of safety or efficacy in this trial
  • Require the use of any concomitant medication that, in the investigator's opinion, has the potential to cause an adverse effect when given with the Investigational Product (IP) or will interfere with the interpretation of the trial results
  • Subject with known abnormal reduction in muscle mass, as judged by the investigator

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03819218


Contacts
Layout table for location contacts
Contact: Birgitte Vestbjerg +4520772575 bve@mc2therapeutics.com

Locations
Layout table for location information
Czechia
PRO SANUM a.s. Recruiting
Prague, Czechia, 110 00
Contact: Alena Cerna, MUDr         
Germany
Dept. of Dermatology, Venereology and Allergology Not yet recruiting
Frankfurt, Frankfurt/Main, Germany, 60590
Contact: Andreas Pinter, MD         
Sponsors and Collaborators
Drug Delivery Solutions Ltd. (part of MC2 Therapeutics)
Investigators
Layout table for investigator information
Principal Investigator: Andreas Pinter, MD Dept. of Dermatology, Venereology and Allergology

Layout table for additonal information
Responsible Party: Drug Delivery Solutions Ltd. (part of MC2 Therapeutics)
ClinicalTrials.gov Identifier: NCT03819218     History of Changes
Other Study ID Numbers: MC2-01-C6
First Posted: January 28, 2019    Key Record Dates
Last Update Posted: January 28, 2019
Last Verified: January 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Betamethasone-17,21-dipropionate
Betamethasone
Betamethasone Valerate
Betamethasone benzoate
Betamethasone sodium phosphate
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents