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

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ClinicalTrials.gov Identifier: NCT03462927
Recruitment Status : Recruiting
First Posted : March 13, 2018
Last Update Posted : March 13, 2018
Sponsor:
Information provided by (Responsible Party):
Drug Delivery Solutions Ltd. (part of MC2 Therapeutics)

Brief 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.

Condition or disease Intervention/treatment Phase
Psoriasis Vulgaris Drug: MC2-01 Cream Drug: CAL/BDP combination 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, 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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : February 8, 2018
Estimated Primary Completion Date : August 17, 2018
Estimated Study Completion Date : August 17, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Arm Intervention/treatment
Experimental: MC2-01 Cream
MC2-01 cream (CAL and BDP, w/w 0.005%/ 0.064%).
Drug: MC2-01 Cream
MC2-01 (calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%)

Active Comparator: CAL/BDP combination
CAL/BDP ointment (w/w 0.005%/0.064%).
Drug: CAL/BDP combination
Calcipotriene/betamethasone (calcipotriene/ betamethasone dipropionate, w/w 0.005%/0.064%)




Primary Outcome Measures :
  1. Pharmacokinetic parameters of active ingredients and their main metabolites [ Time Frame: Week 4 and Week 8 ]
    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 and Week 8 ]
    Area under the time-concentration curve from time zero to infinity [AUC0-∞]

  3. Pharmacokinetic parameters of active ingredients and their main metabolites [ Time Frame: Week 4 and Week 8 ]
    Area under the time-concentration curve from time zero to 7 hours [AUC0-7]

  4. Pharmacokinetic parameters of active ingredients and their main metabolites [ Time Frame: Week 4 and Week 8 ]
    Maximum Plasma Concentration [Cmax]

  5. Pharmacokinetic parameters of active ingredients and their main metabolites [ Time Frame: Week 4 and Week 8 ]
    Time to maximum plasma drug concentration [Tmax]

  6. Pharmacokinetic parameters of active ingredients and their main metabolites [ Time Frame: Week 4 and Week 8 ]
    Elimination half-life [T½]


Secondary Outcome Measures :
  1. Hypothalamic-pituitary-adrenal [HPA] axis evaluation [ Time Frame: Week 4 and Week 8 ]
    HPA axis evaluation using an Adrenocorticotropic hormone [ACTH] challenge test. The number of subjects with a serum cortisol level of 18 µg/dL or less at 30 minutes after ACTH challenge

  2. Calcium metabolism evaluation [ Time Frame: Week 4 and Week 8 ]
    Changes from baseline in albumin-corrected serum calcium [mmol/L]

  3. Calcium metabolism evaluation [ Time Frame: Week 4 and Week 8 ]
    24-hour urinary calcium excretion [mmol/L]

  4. Calcium metabolism evaluation [ Time Frame: Week 4 and Week 8 ]
    ratio of urinary calcium to creatinine [Serum Calcium (mmol/L) x Urine Creatinine (mmol/L)]



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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;
  • Use of topical treatments, except for emollients and non-medicated shampoos, with a possible effect on psoriasis within 2 weeks prior to Visit 1/Day 0 and during the trial period;
  • Systemic treatment with biological therapies
  • Initiation of, or expected changes to, concomitant medication that may affect psoriasis during the trial period;
  • Depression and endocrine disorders known to affect cortisol levels or HPA axis integrity, non-nocturnal sleep patterns
  • Systemic medication that suppresses the immune system within 4 weeks prior to the Visit 1/Day 0 and during the trial period;
  • Clinical signs of skin infection with bacteria, viruses, or fungi;
  • 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 may pose a risk to the safety of the subject, or may interfere with the assessment of safety or efficacy in this trial;

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): NCT03462927


Contacts
Contact: Birgitte Vestbjerg +4520772575 bve@mc2therapeutics.com

Locations
United States, Florida
Lenus Research and Medical Group Recruiting
Sweetwater, Florida, United States, 33172
Contact: Ana Elosegui, MD         
Sponsors and Collaborators
Drug Delivery Solutions Ltd. (part of MC2 Therapeutics)
Investigators
Principal Investigator: George Han Department of Dermatology, Mount Sinai Beth Israel

Responsible Party: Drug Delivery Solutions Ltd. (part of MC2 Therapeutics)
ClinicalTrials.gov Identifier: NCT03462927     History of Changes
Other Study ID Numbers: MC2-01-C3
First Posted: March 13, 2018    Key Record Dates
Last Update Posted: March 13, 2018
Last Verified: March 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Betamethasone-17,21-dipropionate
Anti-Inflammatory Agents