calcipotriene and Pain

The well-established sequential use of topical calcipotriene and topical betamethasone dipropionate in combination has been shown to provide greater benefit than either monotherapy. A newer topical fixed combination formulation of calcipotriene 0.005% and betamethasone dipropionate 0.064% in a cream base (Cal/BD cream) is effective with high patient ratings for convenience and tolerability. The current study compares patient satisfaction between Cal/BD foam and Cal/BD cream formulations. Study Design and Patient Demographics: This is a single-use, split body, open label study involving 20 subjects. Ten subjects additionally had scalp psoriasis. Study treatments were applied by the investigator in a randomized manner and patients completed questionnaires to assess treatment preferences.. Both Cal/BD formulations provided rapid and significant improvement in symptoms of pruritus, stinging, burning, and pain; with no statistically significant difference in response between the 2 treatments. Overall, Cal/BD cream outperformed Cal/BD foam on several key measures for vehicle features and patient satisfaction. For non-scalp application, 55% of subjects preferred Cal/BD cream over Cal/BD foam. For the scalp, 60% of subjects preferred Cal/BD cream over Cal/BD foam. No adverse events were reported during the study.. Results of this current study indicate high levels of patient satisfaction with Cal/BD cream and a preference for the cream base over foam for the treatment of body and scalp psoriasis.   J Drugs Dermatol. 2023;22(3): doi:10.36849/JDD.7165.

Topics: Emollients; Humans; Pain; Patient Preference; Pilot Projects; Psoriasis

Wound management is a critical factor when treating patients with the inherited skin fragility disease dystrophic epidermolysis bullosa (DEB). Due to genetic defects in structural proteins, skin and mucous epithelia are prone to blistering and chronic wounding upon minor trauma. Furthermore, these wounds are commonly associated with excessive pruritus and predispose to the development of life-threatening squamous cell carcinomas, underscoring the unmet need for new therapeutic options to improve wound healing in this patient cohort. Vitamin D3 is acknowledged to play an important role in wound healing by modulating different cellular processes that impact epidermal homeostasis and immune responses. In this study, we evaluate the safety and efficacy of low-dose calcipotriol, a vitamin D3 analogue, in promoting wound healing and reducing itch and pain in patients with DEB.. Six patients completed the clinical trial and were included into the final analysis. Topical low-dose calcipotriol treatment led to a significant reduction in wound area at day 14 compared to placebo (88.4% vs. 65.5%, P < 0.05). Patients also reported a significant reduction of pruritus with calcipotriol ointment compared to placebo over the entire course of the treatment as shown by itch scores of 3.16 vs 4.83 (P < 0.05) and 1.83 vs 5.52 (P < 0.0001) at days 14 and 28, respectively. Treatment with low-dose calcipotriol did not affect serum calcium levels and improved the species richness of the wound microbiome, albeit with no statistical significance.. Our results show that topical treatment with low-dose calcipotriol can accelerate wound closure and significantly reduces itch, and can be considered a safe and readily-available option to improve local wound care in DEB patients. Trial Registration EudraCT: 2016-001,967-35. Registered 28 June 2016, https://www.clinicaltrialsregister.eu/ctr-search/trial/2016-001967-35/AT.

Topics: Calcitriol; Collagen Type VII; Double-Blind Method; Epidermolysis Bullosa Dystrophica; Humans; Ointments; Pain; Pruritus; Wound Healing

Topical photodynamic therapy (PDT) is an approved treatment for actinic keratosis (AK). To enhance the efficacy of PDT for AKs, physical and chemical pretreatments have been suggested.. To compare the efficacy and safety of the combination of topical calcipotriol (CAL) before methyl aminolaevulinate (MAL)-PDT for AKs of the scalp vs. conventional MAL-PDT in a randomized controlled clinical trial.. Twenty patients with multiple AKs on the scalp were randomized to receive conventional MAL-PDT with previous curettage on one side of the scalp and CAL-assisted MAL-PDT once a day for 15 days before illumination on the other side. After 3 months, patients were evaluated for clearance of AKs, side-effects and histopathology before and after the procedure. Protoporphyrin IX (PpIX) fluorescence was measured before and after illumination on both sides.. All 20 patients completed the study. Overall AK clearance rates were 92·1% and 82·0% for CAL-PDT and conventional PDT, respectively (P < 0·001). Grade 1 AKs showed similar response rates for both sides (P = 0·055). However, grade II AKs showed more improvement on the CAL-PDT side (90%) than on the MAL-PDT side (63%) (P < 0·001). Before illumination, PpIX fluorescence intensity was higher on the CAL-assisted side (P = 0·048). The treatment was more painful on the CAL-PDT side, although well tolerated. The mean visual analogue scale score was 5·4 ± 1·4 on the CAL-PDT side and 4·0 ± 0·69 on the conventional MAL-PDT side (P = 0·001). Side-effects such as erythema (P = 0·019), oedema (P = 0·002) and crusts (P < 0·001) were more pronounced on the CAL-assisted side. Histopathological analyses were obtained from five patients and both sides showed improved keratinocyte atypia following PDT, with slightly more improvement on the CAL-assisted side.. CAL-assisted PDT proved to be safe and more effective than conventional MAL-PDT for the treatment of AKs on the scalp. CAL pretreatment increased PpIX accumulation within the skin and may have enhanced the efficacy in this first human trial.

Topics: Aged; Aged, 80 and over; Aminolevulinic Acid; Calcitriol; Dermatologic Agents; Drug Therapy, Combination; Follow-Up Studies; Humans; Keratosis, Actinic; Male; Middle Aged; Pain; Pain Measurement; Photochemotherapy; Photosensitizing Agents; Scalp Dermatoses; Skin; Treatment Outcome

Although 40% of psoriasis patients reported skin pain, this symptom is often underestimated. A new formula of calcipotriol plus betamethasone dipropionate (Cal/BD) has been recently approved for psoriasis treatment. Therefore, we aimed to evaluate the efficacy of Cal/BD aerosol foam on skin pain of patients with plaque psoriasis.. A real-life 4-week prospective, open study on Cal/BD aerosol foam (not compared to vehicle or emollient cream) was performed in adult psoriasis patients attending three Dermatology units located in Campania region, Italy, between March and October 2018. Inclusion criteria were a history of skin pain over the last week and psoriatic involvement of the palmar area. Before (t0) and after a course of once daily application of Cal/BD aerosol foam for 4 weeks (t1), the following items were evaluated: Psoriasis Area and Severity Index (PASI), Physician Global Assessment (PGA) index of target plaque on palmar region, subjective skin pain features through Pain Qualities Assessment Scale questionnaire and skin pain threshold measured by pressure digital algometer at palmar psoriatic plaques.. Seventy-five patients (43 male, mean age of 43.2 years) were enrolled. After 4 weeks of therapy with Cal/BD aerosol foam, a significant improvement in both PASI (mean: 6.5 ± 2.1 at t0 vs. 2.3 ± 1.6 at t1) and palmar plaques PGA (mean: 3.6 at t0 vs. 1.7 at t1) was observed (P < 0.001). The mean intensity score of skin pain decreased from 7.6 to 1.3 (P < 0.001); among skin pain qualities, intense, sensible, aching and unpleasant showed the highest rate of reduction (t0-t1: 6.3, 6.3, 6.1 and 5.8, respectively). Pain threshold of palmar skin lesions increased at t1.. Our real-life study suggested that Cal/BD aerosol foam may represent a valid topical anti-psoriatic treatment, not only improving skin lesions, but also relieving cutaneous pain, thus contributing to ameliorate patients' quality of life.

Topics: Administration, Topical; Adult; Aerosols; Aged; Anti-Inflammatory Agents; Betamethasone; Calcitriol; Dermatologic Agents; Drug Combinations; Female; Hand; Humans; Male; Middle Aged; Pain; Pain Measurement; Pain Threshold; Prospective Studies; Psoriasis; Severity of Illness Index; Young Adult