A Maximal Use Trial Evaluating the Pharmacokinetic Profile of MC2-01 Cream
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.
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
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.
|Eligible Ages||18 Years and Over|
- - 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.
- - 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.
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.
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.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
|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 Affiliation||Department of Dermatology, Mount Sinai Beth Israel|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
The disease, disorder, syndrome, illness, or injury that is being studied.
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.
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, 33172
Ana Elosegui, MD