Non‐invasive clinical and microscopic evaluation of the response to treatment with clobetasol cream vs. calcipotriol/betamethasone dipropionate foam in mild to moderate plaque psoriasis: an investigator‐initiated, phase IV, unicentric, open, randomized clinical trial

Yélamos, Oriol; Alejo, B.; Ertekin, Sümeyre Seda; Villa-Crespo, Lorena; Zamora-Barquero, S; Martínez, Núria; Domínguez, M. Ángeles; Iglesias, Pablo; Herrero, Astrid; Malvehy, Josep; Puig, Susana

doi:10.1111/jdv.16559

Cited by 17 publications

(14 citation statements)

References 38 publications

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“…We observed a good correlation between ET and TSS. Our results on the decrease of ET under therapy were in good agreement with previous studies using topical ( 25 , 40 ) and non-biologic systemic therapies ( 19 ). In contrast to conventional therapies of psoriasis, we observed an accelerated decrease of ET .…”

Section: Discussionsupporting

confidence: 92%

Case report: Optical coherence tomography for monitoring biologic therapy in psoriasis and atopic dermatitis

et al. 2022

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Biologic therapies are increasingly used to treat chronic inflammatory skin diseases such as psoriasis and atopic dermatitis. In clinical practice, scores based on evaluation of objective and subjective symptoms are used to assess disease severity, leading to evaluation of treatment goals with clinical decisions on treatment initiation, switch to another treatment modality or to discontinue current treatment. However, this visual-based scoring is relatively subjective and inaccurate due to inter- and intraobserver reliability. Optical coherence tomography (OCT) is a fast, high-resolution, in vivo imaging modality that enables the visualization of skin structure and vasculature. We evaluated the use of OCT for quantification and monitoring of skin inflammation to improve objective assessment of disease activity in patients with psoriasis and atopic dermatitis. We assessed the following imaging parameters including epidermal thickness, vascular density, plexus depth, vessel diameter, and vessel count. A total of four patients with psoriasis or atopic dermatitis were treated with biologic agents according to current treatment guidelines. OCT was used to monitor their individual treatment response in a target lesion representing disease activity for 52 weeks. Psoriatic and eczema lesions exhibited higher epidermal thickness, increased vascular density, and higher vessel count compared to uninvolved skin. An upward shift of the superficial vascular plexus accompanied by smaller vessel diameters was seen in psoriasis in contrast to atopic dermatitis, where larger vessels were observed. A response to biologic therapy was characterized by normalization of the imaging parameters in the target lesions in comparison to uninvolved skin during the observation period of 52 weeks. Optical coherence tomography potentially serves as an instrument to monitor biologic therapy in inflammatory skin diseases. Imaging parameters may enable objective quantification of inflammation in psoriasis or atopic dermatitis in selected representative skin areas. OCT may reveal persistent subclinical inflammation in atopic dermatitis beyond clinical remission.

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Section: Discussionsupporting

confidence: 92%

Case report: Optical coherence tomography for monitoring biologic therapy in psoriasis and atopic dermatitis

et al. 2022

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“…9 Cal/BD foam has also shown superior efficacy to its individual components, calcipotriol and betamethasone dipropionate, Cal/BD gel and ointment formulations as well as clobetasol cream. [11][12][13][14] In one study, the percentage of patients achieving treatment success after 4 weeks, defined by a PGA score is higher in the Cal/BD foam group than in the Cal/BD ointment group (54.6% vs 43%). 13 In a second study, 52.1% of patients receiving Cal/BD foam achieved PASI75 after 4 weeks, compared with 24.3% receiving Cal/BD gel.…”

Section: Short Term Efficacymentioning

confidence: 99%

“…12 Cal/BD foam has also demonstrated superior effectiveness to clobetasol cream, along with higher levels of patient satisfaction. 14 In a recent interventional investigator-initiated Phase IV study, more patients treated with Cal/BD foam achieved a total clinical score of 1 or less, indicating better clinical resolution than with clobetasol. 14 Cal/BD foam induced a significantly faster response than clobetasol, with 80% of patients achieving a meaningful reduction in total clinical score, versus 43.4% at 4 weeks.…”

Section: Short Term Efficacymentioning

confidence: 99%

“…14 In a recent interventional investigator-initiated Phase IV study, more patients treated with Cal/BD foam achieved a total clinical score of 1 or less, indicating better clinical resolution than with clobetasol. 14 Cal/BD foam induced a significantly faster response than clobetasol, with 80% of patients achieving a meaningful reduction in total clinical score, versus 43.4% at 4 weeks. 14 Despite the increased penetration of calcipotriol and betamethasone, no increased AEs or negative safety outcomes has been observed.…”

Section: Short Term Efficacymentioning

confidence: 99%

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Short Term and Long-Term Efficacy of Calcipotriene/ Betamethasone Dipropionate Foam Combination

Jalili¹,

Bewley²,

Sticherling³

et al. 2022

CCID

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Psoriasis is a well-known chronic disease characterized by the development of erythematous, indurated, scaly, pruritic plaques on the skin with cycles of remission and symptom flare-ups. The management of patients with chronic plaque psoriasis has been more challenging since the Covid-19 pandemic as health care professionals have had to adapt to remote consultations for some patients, and patients have had to adapt to the changing health landscape. The rapid resolution of psoriasis symptoms especially those with a substantial impact on quality of life can improve patient satisfaction and adherence, making it an important factor in successful treatment. Cal/BD foam contributes to improved patient adherence and treatment outcome through its rapid action and superior efficacy versus Cal or BD monotherapy, Cal/BD ointment and gel and clobetasol cream in the short-term flare treatment of psoriasis. Moreover, the benefits of proactive long-term management of psoriasis compared to reactive management and its favourable safety profile are higher efficacy and a better health-related quality of life. Cal/BD foam should be considered an effective topical treatment for short-term flare treatment and long-term control of adult psoriatic patients.

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“…Furthermore, a prospective, open‐label, study ( N = 36) found that Cal/BD foam treatment resulted in a significantly higher number of patients achieving total or almost total lesion clearance (TCS ≤ 1) after 4 weeks compared with clobetasol cream (63.2% vs. 18.8%, respectively; P = 0.016) 11 . In addition, Cal/BD foam induced a faster and greater reduction of epidermal thickness ( P < 0.049) and patients' treatment satisfaction was higher ( P < 0.03).…”

Section: Efficacymentioning

confidence: 99%

Early efficacy and safety data with fixed‐dose combination calcipotriol/betamethasone dipropionate foam attributed to mechanism of absorption and steroid potency

Tada

Iversen

Koo

2021

Acad Dermatol Venereol

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Topical therapy is the mainstay of treatment for the majority of patients with psoriasis vulgaris (chronic plaque psoriasis), with combinations of vitamin D analogues and glucocorticoids having been shown to negate many of the negative effects associated with either monocomponent individually. Following the established efficacy of fixed‐dose combination calcipotriol (Cal; 50 µg/g) plus betamethasone dipropionate (BD; 0.5 mg/g) ointment and gel formulations, a novel Cal/BD foam formulation was developed. When applied, Cal/BD foam forms a supersaturated solution on the skin, increasing the penetration and bioavailability of Cal and BD. Early data indicate that this results in improved efficacy outcomes versus Cal/BD ointment, without negatively affecting safety outcomes (such as the incidence/severity of side effects or impacted calcium homeostasis or hypothalamic‐pituitary‐adrenal axis). This article discusses the potency and absorption of fixed‐dose combination Cal/BD foam, as well as the positive early efficacy and safety data associated with its utilisation in the treatment of psoriasis vulgaris.

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Non‐invasive clinical and microscopic evaluation of the response to treatment with clobetasol cream vs. calcipotriol/betamethasone dipropionate foam in mild to moderate plaque psoriasis: an investigator‐initiated, phase IV, unicentric, open, randomized clinical trial

Cited by 17 publications

References 38 publications

Case report: Optical coherence tomography for monitoring biologic therapy in psoriasis and atopic dermatitis

Case report: Optical coherence tomography for monitoring biologic therapy in psoriasis and atopic dermatitis

Short Term and Long-Term Efficacy of Calcipotriene/ Betamethasone Dipropionate Foam Combination

Early efficacy and safety data with fixed‐dose combination calcipotriol/betamethasone dipropionate foam attributed to mechanism of absorption and steroid potency

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