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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 : Completed
First Posted : March 13, 2018
Results First Posted : December 24, 2019
Last Update Posted : December 24, 2019
Sponsor:
Information provided by (Responsible Party):
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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 63 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
Actual Primary Completion Date : August 4, 2018
Actual Study Completion Date : August 4, 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. Maximum Plasma Concentration (Cmax) of the Active Ingredient Calcipotriene [ Time Frame: Week 4 ]
    Geometric Mean for Maximum Plasma Concentration [Cmax] for the active ingredient Calcipotriene. Plasma concentration was measured at the following timepoints: pre-dose, 30 min, 1, 2, 3, 5 and 7 hours post-dose

  2. Maximum Plasma Concentration (Cmax) of the Active Ingredient Calcipotriene [ Time Frame: Week 8 ]
    Geometric Mean for Maximum Plasma Concentration [Cmax] for the active ingredient Calcipotriene. Plasma concentration was measured at the following timepoints: pre-dose, 30 min, 1, 2, 3, 5 and 7 hours post-dose

  3. Maximum Plasma Concentration (Cmax) of Active Ingredient Betamethasone Dipropionate [ Time Frame: Week 4 ]
    Geometric Mean for Maximum Plasma Concentration [Cmax] for the active ingredient Betamethasone Dipropionate. Plasma concentration was measured at the following timepoints: pre-dose, 30 min, 1, 2, 3, 5 and 7 hours post-dose

  4. Maximum Plasma Concentration (Cmax) of Active Ingredient Betamethasone Dipropionate [ Time Frame: Week 8 ]
    Geometric Mean for Maximum Plasma Concentration [Cmax] for the active ingredient Betamethasone Dipropionate. Plasma concentration was measured at the following timepoints: pre-dose, 30 min, 1, 2, 3, 5 and 7 hours post-dose

  5. Maximum Plasma Concentration (Cmax) of the Metabolite MC1080 [ Time Frame: Week 4 ]
    Geometric Mean for Maximum Plasma Concentration [Cmax] for the metabolite MC1080. Plasma concentration was measured at the following timepoints: pre-dose, 30 min, 1, 2, 3, 5 and 7 hours post-dose

  6. Maximum Plasma Concentration (Cmax) of the Metabolite MC1080 [ Time Frame: Week 8 ]
    Geometric Mean for Maximum Plasma Concentration [Cmax] for the metabolite MC1080. Plasma concentration was measured at the following timepoints: pre-dose, 30 min, 1, 2, 3, 5 and 7 hours post-dose

  7. Maximum Plasma Concentration (Cmax) of Metabolite Betamethasone 17-propionate [ Time Frame: Week 4 ]
    Geometric Mean for Maximum Plasma Concentration [Cmax] for the metabolite Betamethasone 17-propionate. Plasma concentration was measured at the following timepoints: pre-dose, 30 min, 1, 2, 3, 5 and 7 hours post-dose

  8. Maximum Plasma Concentration (Cmax) of Metabolite Betamethasone 17-propionate [ Time Frame: Week 8 ]
    Geometric Mean for Maximum Plasma Concentration [Cmax] for the metabolite Betamethasone 17-propionate. Plasma concentration was measured at the following timepoints: pre-dose, 30 min, 1, 2, 3, 5 and 7 hours post-dose


Secondary Outcome Measures :
  1. Number of Subjects With Hypothalamic-pituitary-adrenal [HPA] Suppression After 4 Weeks of Treatment [ Time Frame: Week 4 ]

    The HPA axis evaluation is based on an Adrenocorticotropic hormone [ACTH] challenge test, defined by a 30 minutes ACTH stimulated cortisol value. Only subject with no HPA suppression at baseline were included in the analysis.

    The outcome measure lists the number of subjects with HPA suppression 30 minutes after ACTH challenge


  2. Number of Subjects With Hypothalamic-pituitary-adrenal [HPA] Suppression After 8 Weeks of Treatment [ Time Frame: Week 8 ]
    The HPA challenge test were only performed on subjects that were assigned to the MC2-01 cream group. Out of a total of 32 subjects, 5 subjects were excluded from the analysis as they had HPA suppression at baseline

  3. Calcium Metabolism Evaluation in Albumin-corrected Serum Calcium [ Time Frame: Baseline and week 4 ]
    Changes from baseline of albumin-corrected serum calcium [mmol/L]

  4. Calcium Metabolism Evaluation in Albumin-corrected Serum Calcium [ Time Frame: Baseline and week 8 ]
    Changes from baseline in albumin-corrected serum calcium [mmol/L]

  5. Calcium Metabolism Evaluation of 24-hour Urinary Calcium Excretion [ Time Frame: Baseline and week 4 ]
    Changes from baseline of 24-hour urinary calcium excretion [mmol/day]

  6. Calcium Metabolism Evaluation of 24-hour Urinary Calcium Excretion [ Time Frame: Baseline and week 8 ]
    Changes from baseline of 24-hour urinary calcium excretion [mmol/day]

  7. Calcium Metabolism Evaluation of the Ratio of Urinary Calcium to Creatinine [ Time Frame: Baseline and week 4 ]
    Changes from baseline in ratio of urinary calcium to creatinine defined as urinary calcium (mmol)/creatinine (g)

  8. Calcium Metabolism Evaluation of the Ratio of Urinary Calcium to Creatinine [ Time Frame: Baseline and week 8 ]
    Changes from baseline in ratio of urinary calcium to creatinine defined as urinary calcium (mmol)/creatinine (g)



Information from the National Library of Medicine

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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


Locations
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United States, Florida
Lenus Research and Medical Group
Sweetwater, Florida, United States, 33172
Sponsors and Collaborators
MC2 Therapeutics
Investigators
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Principal Investigator: George Han Department of Dermatology, Mount Sinai Beth Israel
  Study Documents (Full-Text)

Documents provided by MC2 Therapeutics:
Study Protocol  [PDF] December 20, 2017
Statistical Analysis Plan  [PDF] September 21, 2018

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Responsible Party: MC2 Therapeutics
ClinicalTrials.gov Identifier: NCT03462927    
Other Study ID Numbers: MC2-01-C3
First Posted: March 13, 2018    Key Record Dates
Results First Posted: December 24, 2019
Last Update Posted: December 24, 2019
Last Verified: December 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases