Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2025 Jun;15(6):1441-1453.
doi: 10.1007/s13555-025-01418-x. Epub 2025 Apr 24.

Best Responders and Super-Responders to Calcipotriol and Betamethasone Dipropionate PAD-Cream: A Post Hoc Pooled Analysis of Two Phase 3 Trials

Andreas Pinter  1 , Jordi Galván  2 , Frank Freischläger  3
Affiliations

Best Responders and Super-Responders to Calcipotriol and Betamethasone Dipropionate PAD-Cream: A Post Hoc Pooled Analysis of Two Phase 3 Trials

Andreas Pinter et al. Dermatol Ther (Heidelb). 2025 Jun.

Abstract

Introduction: Individual endpoints from phase 3 trials demonstrated high efficacy and convenience for the calcipotriol/betamethasone dipropionate (CAL/BDP) cream based on polyaphron dispersion (PAD) technology compared to CAL/BDP gel. The objectives are to assess the proportion of best responders to CAL/BDP PAD-cream at weeks 4 and 8 and to identify the super-responders through the patients' key baseline characteristics associated with best response.

Methods: This was a post hoc pooled analysis of adult patients with mild-to-moderate psoriasis from two phase 3 trials: MC2-01-C2 (NCT03308799) and MC2-01-C7 (NCT03802344). Patients were randomly assigned (3:1:3) to CAL/BDP PAD-cream, PAD-cream vehicle, or CAL/BDP gel once daily. Best responders at weeks 4 and 8 were defined as patients achieving a restrictive endpoint comprising the combination of Physician's Global Assessment (PGA) controlled disease, modified Psoriasis Area and Severity Index (mPASI) success, and Dermatology Life Quality Index (DLQI) satisfaction. Best response rates were compared between treatments by logistic regression using multiple imputation. A classification and regression tree (CART) based on observed cases identified super-responders through the key baseline characteristics associated with best response among CAL/BDP PAD-cream users. All analyses were based on the modified intention-to-treat (mITT) population.

Results: The mITT included 551 patients on CAL/BDP PAD-cream, 542 on CAL/BDP gel, and 178 on vehicle. The CAL/BDP PAD-cream group showed a statistically significant higher best response rate compared to CAL/BDP gel at week 4 (10.7% vs 6.1%; p = 0.0048) and week 8 (27.4% vs 16.1%; p < 0.0001), and also compared to vehicle. Among CAL/BDP PAD-cream users, 63.6% of patients with a baseline DLQI < 7 and mPASI < 4.0 achieved best response at week 8 and were considered super-responders.

Conclusion: CAL/BDP PAD-cream demonstrated higher best response rates compared to CAL/BDP gel and vehicle in adults with mild-to-moderate psoriasis. Baseline DLQI and mPASI scores may predict which patients are most likely to achieve best response to CAL/BDP PAD-cream.

Trials registration: ClinicalTrials.gov identifiers, NCT03308799 (MC2-01-C2) and NCT03802344 (MC2-01-C7).

Keywords: Best responders; Betamethasone dipropionate; Calcipotriol; Psoriasis; Psoriasis treatment.

Plain language summary

This study evaluated a new calcipotriol and betamethasone dipropionate (CAL/BDP) cream with polyaphron dispersion (PAD) technology, designed to provide efficacy and safety with greater comfort for patients with mild-to-moderate psoriasis. The study compared the new cream to CAL/BDP gel and a dermatological vehicle to identify patients who responded best and which patient characteristics predicted best outcomes. Data from 1271 adult patients with mild-to-moderate psoriasis who participated in two trials were analyzed. Patients applied CAL/BDP PAD-cream, CAL/BDP gel, or vehicle once daily. Researchers defined “best responders” as patients achieving three key goals after 8 weeks of treatment: (1) clear or almost clear skin, (2) very low psoriasis severity, and (3) no significant impact on quality of life. They also identified “super-responders” as those most likely to achieve best outcomes, based on patient characteristics at the start of the study. CAL/BDP PAD-cream resulted in significantly more best responders compared to gel or vehicle. By week 4, 10.7% of cream users achieved best response compared to 6.1% of gel users. By week 8, these numbers rose to 27.4% for the cream and 16.1% for the gel. Among cream users, patients without an important affection of their quality of life and less severity at the start of the study had the highest likelihood of being super-responders. Overall, CAL/BDP PAD-cream was more effective than gel or vehicle in treating mild-to-moderate psoriasis. Patients with lower baseline disease severity were more likely to benefit the most.

PubMed Disclaimer

Conflict of interest statement

Declarations. Conflict of Interest: Andreas Pinter has no conflicts of interest to declare. Jordi Galván is an employee of Almirall S.A. Frank Freischläger is co-founder and co-owner of Estimondo GmbH. Ethical Approval: The study protocols of the two phase 3 studies were reviewed and approved by local institutional review boards or ethics committees (central institutional review board for trial MC2-01-C2: Quorum, 1501 Fourth Ave, Ste 800, Seattle, WA 98101; independent ethics committee for trial MC2-01-C7: Ethikkommission der Ärztekammer, Hamburg, Weidestraße 122b, 22083 Hamburg, Germany). The study was performed in accordance with the Helsinki Declaration of 1964 and its later amendments. All participants provided written informed to participate in the phase 3 studies.

Figures

Fig. 1
Fig. 1
Decision tree of CART model applied to the CAL/BDP PAD-cream arm to identify the super-responders through the key baseline characteristics associated with higher probability of best response at week 4. CART model is based on observed cases from the CAL/BDP PAD-cream arm at week 4 (n = 512). The super-responders (i.e., subgroups with the higher probability of achieving best response) are marked in a green box with a red outline. P values represent chi-square test results of binary or dichotomized parameters, where the parameter with the smallest p value defines the split. BDP betamethasone dipropionate, BL baseline, BR best responders, CAL calcipotriol, CART classification and regression tree, DLQI Dermatology Life Quality Index, mPASI modified Psoriasis Area and Severity Index, PAD polyaphron dispersion
Fig. 2
Fig. 2
Decision tree of CART model applied to the CAL/BDP PAD-cream arm to identify the super-responders through the key baseline characteristics associated with higher probability of best response at week 8. CART model is based on observed cases from the CAL/BDP PAD-cream arm at week 8 (n = 522). The super-responders (i.e., subgroups with the higher probability of achieving best response) are marked in a green box with red outline. P values represent chi-square test results of binary or dichotomized parameters, where the parameter with the smallest p value defines the split. BDP betamethasone dipropionate, BL baseline, BR best responders, CAL calcipotriol, CART classification and regression tree, DLQI Dermatology Life Quality Index, mPASI modified Psoriasis Area and Severity Index, PAD polyaphron dispersion
See this image and copyright information in PMC

Similar articles

See all similar articles

References

    1. Luna PC, Chu CY, Fatani M, et al. Psychosocial burden of psoriasis: a systematic literature review of depression among patients with psoriasis. Dermatol Ther (Heidelb). 2023;13(12):3043–55. - PMC - PubMed
    1. AlQassimi S, AlBrashdi S, Galadari H, Hashim MJ. Global burden of psoriasis-comparison of regional and global epidemiology, 1990 to 2017. Int J Dermatol. 2020;59(5):566–71. - PubMed
    1. Belinchón Romero I, Dauden E, Ferrándiz Foraster C, González-Cantero Á, Carrascosa Carrillo JM. Therapeutic goals and treatment response evaluation in moderate to severe psoriasis: an experts opinion document. Ann Med. 2021;53(1):1727–36. - PMC - PubMed
    1. Bożek A, Reich A. The reliability of three psoriasis assessment tools: psoriasis area and severity index, body surface area and physician global assessment. Adv Clin Exp Med. 2017;26(5):851–6. - PubMed
    1. Manalo IF, Gilbert KE, Wu JJ. An updated survey for the 2007–2013 period of randomized controlled trials for psoriasis: treatment modalities, study designs, comparators, outcome measures and sponsorship. J Eur Acad Dermatol Venereol. 2015;29(10):1945–50. - PubMed

Associated data

LinkOut - more resources