This Trial is a Randomised, Multicentre, Investigator-blind, Vehicle and Comparator-controlled, Parallel-group Trial With the Purpose of Evaluation Efficacy, Safety and Convenience of the MC2-01 Cream

Study Purpose

This trial is a randomized, investigator-blind, multicentre, vehicle- and comparator-controlled, parallel-group trial with the purpose of evaluating the efficacy, safety and convenience of the MC2-01 cream.

Recruitment Criteria

Accepts Healthy Volunteers

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

No
Study Type

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.

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 - Have a clinical diagnosis of plaque psoriasis (psoriasis vulgaris) of at least 6 months duration that involves the body (trunk and/or limbs) that is amenable to topical treatment with a maximum of 15 g of trial medication per day - Have a PGA of disease severity of mild or moderate on the body (trunk and/or limbs) - Have an mPASI score of at least 3 - Have a treatment area involving 2-30% of the body (trunk and/or limbs).
For subjects with scalp psoriasis included in the treatment area, the total treatment area on body and scalp must not exceed 30%.

Exclusion Criteria:

- Current diagnosis of unstable forms of psoriasis - Other inflammatory skin disease in the treatment area that may confound the evaluation of the psoriasis vulgaris - Presence of pigmentation, extensive scarring, pigmented lesions or sunburn in the treatment areas - Planned excessive or prolonged exposure to either natural or artificial sunlight - History of hypersensitivity to any component of the test product or reference product - Current or past history of hypercalcemia, vitamin D toxicity, severe renal insufficiency, or severe hepatic disorders - Systemic treatment with biological therapies - Use of systemic treatments that suppress the immune system and other systemic chemotherapeutic antineoplastic therapy within 4 weeks prior to Visit 1/Baseline and during the trial - Use of phototherapy within 4 weeks prior to Visit 1/Baseline 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 Visit 1/Baseline - Presence of infections in the treatment area (bacteria, viruses, parasites or fungi) or skin manifestations of atrophic skin, atrophic striae, skin vein fragility, ichthyosis, acne vulgaris, acne rosacea, rosacea, ulcers and wound in the treatment area - Known Human Immunodeficiency Virus (HIV) infection - Have 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 - Initiation of, or expected changes to, concomitant medication that may affect psoriasis

Trial Details

Trial ID:

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.

NCT03802344
Phase

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 3
Lead Sponsor

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

MC2 Therapeutics
Principal Investigator

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

N/A
Principal Investigator Affiliation N/A
Agency Class

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

Industry
Overall Status Recruiting
Countries Czechia, Germany
Conditions

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

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 in daily routines.
In this trial, the MC2-01 cream will be compared to a marketed product CAL/BDP combination and vehicle. The purpose of the trial is to compare the clinical efficacy, safety, and convenience of this cream to the marketed product. The trial will include a 8-week treatment period.

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.

International Sites

Praha 1, Czechia

Status

Recruiting

Address

Dermatovenerologie a korektivní dermatologie

Praha 1, , Těšnov 1163/5 110 00

Site Contact

Blanka Havlíčková, MD

bve@mc2therapeutics.com

+4520772575

University Medical Center Hamburg, Hamburg, Germany

Status

Not yet recruiting

Address

University Medical Center Hamburg

Hamburg, , 20246

Site Contact

Matthias Augustin, Prof., MD

bve@mc2therapeutics.com

+4520772575

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