drugset / Trial / NCT03308799
A Clinical Trial Evaluating Efficacy and Safety of MC2-01 Cream
RandomizedParallel-groupSingle-blindTreatment
Summary
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.
Timeline
- Start
- 2017-10-03
- Primary completion
- 2018-06-08
- Completion
- 2018-06-08
Outcome
Met primary endpoint
paper The proportion of patients achieving PGA treatment success after 8 weeks was statistically significantly greater for CAL/BDP cream PMID 33852251 ↗
paper CAL/BDP cream (37.4%) compared to CAL/BDP TS (22.8%, P<0.0001), and vehicle (3.7%, P<0.0001). PMID 33852251 ↗
release “Accordingly, the trial met its primary endpoint to demonstrate non-inferiority of MC2-01 Cream to Taclonex®.” mc2therapeutics.com ↗
Publications
- Pinter A, Galvan J, Freischlager F. Best Responders and Super-Responders to Calcipotriol and Betamethasone Dipropionate PAD-Cream: A Post Hoc Pooled Analysis of Two Phase 3 Trials. Dermatol Ther (Heidelb). 2025 Jun;15(6):1441-1453. doi: 10.1007/s13555-025-01418-x. Epub 2025 Apr 24.
- Stein Gold L, Pinter A, Armstrong A, Augustin M, Arenberger P, Bhatia N, Praestegaard M, Iversen L, Reich A. Calcipotriene and Betamethasone Dipropionate PAD-Cream Demonstrates Greater Treatment Efficacy in Patients with Moderate-to-Severe Psoriasis Compared to Topical Suspension/Gel: A Subgroup Analysis of Two Phase 3 Studies. Dermatol Ther (Heidelb). 2023 Sep;13(9):2031-2044. doi: 10.1007/s13555-023-00979-z. Epub 2023 Jul 25.
- Feldman SR, Praestegaard M, Andreasen AH, Selmer J, Holm-Larsen T. Validation of the Self-Reported Psoriasis Treatment Convenience Scale (PTCS). Dermatol Ther (Heidelb). 2021 Dec;11(6):2077-2088. doi: 10.1007/s13555-021-00626-5. Epub 2021 Oct 14.
- Stein Gold L, Green LJ, Dhawan S, Vestbjerg B, Praestegaard M, Selmer J. A Phase 3, Randomized Trial Demonstrating the Improved Efficacy and Patient Acceptability of Fixed Dose Calcipotriene and Betamethasone Dipropionate Cream. J Drugs Dermatol. 2021 Apr 1;20(4):420-425. doi: 10.36849/JDD.2021.5653.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | calcipotriene/betamethasone dipropionate | Unknown | 0.005 % | Other |
| Subject | calcipotriene/betamethasone dipropionate | Unknown | 0.064 % | Other |