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Review, Journal: Calcipotriol and Betamethasone Dipropionate Cream Based on PAD Technology for the Treatment of Plaque Psoriasis: A Narrative Review. (Pubmed Central) - Sep 23, 2023 CAL/BDP PAD-cream and CAL/BDP foam showed equivalent efficacy and quality of life at their recommended treatment duration, whereas greater treatment satisfaction for CAL/BDP PAD-cream was found after one week of treatment. Overall, the high patient acceptability and treatment satisfaction observed with CAL/BDP PAD-cream in clinical trials may lead to improved adherence and hence higher efficacy in clinical practice.
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Journal: Enhanced Skin Deposition of Betamethasone Dipropionate from a Novel Formulation and Drug Delivery Technology. (Pubmed Central) - Jun 23, 2023 CAL/BDP PAD-cream is a novel topical treatment of psoriasis that has a high efficacy and a favourable safety profile combined with a superior patient reported treatment convenience. The novel PAD technology-based cream formulation delivered more BDP into the upper stratum corneum and lower epidermis than a traditional topical suspension.
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Review, Journal: Polyaphron Dispersion Technology, A Novel Topical Formulation and Delivery System Combining Drug Penetration, Local Tolerability and Convenience of Application. (Pubmed Central) - Sep 3, 2022 P3 Example data are presented of enhanced drug penetration from PAD formulations, including dermal delivery of calcipotriene, betamethasone dipropionate and tacrolimus as well as ocular delivery of ciclosporin A. Local tolerability is an important safety parameter for topical formulations, where high levels of surfactants can cause skin irritation...PAD formulations can generally be designed to meet these criteria. In conclusion, PAD technology provides high flexibility in topical drug design and can be applied to several body locations without compromising efficacy, safety or convenience of therapy.Clinical Trial Register: Clinicaltrials.gov: NCT03802344.
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P3 data, Retrospective data, Journal: A pooled analysis of randomized, controlled, phase 3 trials investigating the efficacy and safety of a novel, fixed dose calcipotriene and betamethasone dipropionate cream for the topical treatment of plaque psoriasis. (Pubmed Central) - Jan 19, 2022 P3 Because of Its High Efficacy and Safety Profile, As Well as Its Ease of Use, Cal/BDP CREAM CAN Be Used AS A First-Line Topical Therapy for the PSO. The novel fixed dose combination CAL/BDP PAD-cream offers greater efficacy, superior patient QoL and equivalent favourable safety for the topical treatment of psoriasis, in comparison to the currently available topical suspension/gel.
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Enrollment change, Trial completion date, Trial termination: A Maximal Use Trial Evaluating the Pharmacokinetic Profile of MC2-01 Cream in Adolescent Subjects (clinicaltrials.gov) - Feb 21, 2021 P2, N=7, Terminated, The novel fixed dose combination CAL/BDP PAD-cream offers greater efficacy, superior patient QoL and equivalent favourable safety for the topical treatment of psoriasis, in comparison to the currently available topical suspension/gel. N=30 --> 7 | Trial completion date: Apr 2021 --> Dec 2020 | Active, not recruiting --> Terminated; Lack of recruitment
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Trial completion date, Trial primary completion date: A Maximal Use Trial Evaluating the Pharmacokinetic Profile of MC2-01 Cream in Adolescent Subjects (clinicaltrials.gov) - Sep 29, 2020 P2, N=30, Active, not recruiting, N=30 --> 7 | Trial completion date: Apr 2021 --> Dec 2020 | Active, not recruiting --> Terminated; Lack of recruitment Trial completion date: Jul 2020 --> Apr 2021 | Trial primary completion date: Jul 2020 --> Feb 2021
- |||||||||| Wynzora (calcipotriene/betamethasone dipropionate) / MC2 Therap
Trial completion: 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 (clinicaltrials.gov) - Oct 18, 2019 P3, N=498, Completed, Recruiting --> Active, not recruiting Active, not recruiting --> Completed
- |||||||||| Wynzora (calcipotriene/betamethasone dipropionate) / MC2 Therap
Enrollment closed: 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 (clinicaltrials.gov) - Aug 14, 2019 P3, N=476, Active, not recruiting, Active, not recruiting --> Completed Recruiting --> Active, not recruiting
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