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

Study Purpose

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.

Recruitment Criteria

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Accepts Healthy Volunteers
No

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Study Type
Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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;

Trial Details

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

Trial ID:
NCT03462927

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase
Phase 2

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Lead Sponsor
Drug Delivery Solutions Ltd. (part of MC2 Therapeutics)

The person who is responsible for the scientific and technical direction of the entire clinical study.

Principal Investigator
George Han
Principal Investigator Affiliation Department of Dermatology, Mount Sinai Beth Israel

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Agency Class
Industry
Overall Status Recruiting
Countries United States

The disease, disorder, syndrome, illness, or injury that is being studied.

Conditions
Psoriasis Vulgaris
Additional Details

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Lenus Research and Medical Group, Sweetwater, Florida

Status

Recruiting

Address

Lenus Research and Medical Group

Sweetwater, Florida, 33172

Site Contact

Ana Elosegui, MD

+4520772575

Nearest Location

Site Contact

Ana Elosegui, MD

+4520772575

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