A Clinical Trial Evaluating Efficacy and Safety of MC2-01 Cream

M

MC2 Therapeutics

Status and phase

Completed
Phase 3

Conditions

Psoriasis Vulgaris

Treatments

Drug: Cream vehicle
Drug: MC2-01 cream
Drug: Cal/BDP combination

Study type

Interventional

Funder types

Industry

Identifiers

NCT03308799
MC2-01-C2

Details and patient eligibility

About

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

Full 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 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.

Enrollment

794 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • 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 trunk and/or limbs that is amenable to topical treatment with a maximum of 100 g of trial medication per week
  • Have a PGA of disease severity of mild or moderate on the body (trunk and/or limbs)
  • An mPASI score of at least 2
  • Have a treatment area involving 2- 30% of the body surface area (BSA)

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 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 the baseline visit 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
  • Clinical signs of skin infection with bacteria, viruses, or fungi
  • Known Human Immunodeficiency Virus (HIV) infection
  • 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 design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

794 participants in 3 patient groups, including a placebo group

MC2-01 Cream
Experimental group
Description:
MC2-01 (calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%) cream. One application daily for 8 weeks
Treatment:
Drug: MC2-01 cream
Cal/BDP combination
Active Comparator group
Description:
Calcipotriene/betamethasone (calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%). One application daily for 8 weeks.
Treatment:
Drug: Cal/BDP combination
Cream vehicle
Placebo Comparator group
Description:
One application daily for 8 weeks.
Treatment:
Drug: Cream vehicle

Trial documents
2

Trial contacts and locations

0

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location

Resources

© Copyright 2024 Veeva Systems