Efficacy and Safety of Novel Formulation of Clobetasol Propionate 0.025% Cream in Indian Moderate-to-Severe Psoriasis Patients: Phase-2a, Randomized 3-Arm Study

Abstract

Introduction: Clobetasol propionate (0.05% standard dose formulation), a topical corticosteroid, leads to systemic side-effects like hypothalamic-pituitary-adrenal (HPA) axis suppression at doses as low as 2 g/day. The aim of this study was to evaluate HPA axis suppression, efficacy, and safety of clobetasol propionate (0.025%, formulation 5 and 13) versus currently marketed 0.05% cream in Indian patients with moderate-to-severe psoriasis. Methods: In this phase 2a investigator-blinded study, patients aged C 18 years with moderateto-severe psoriasis were randomized 1:1:1 to receive clobetasol propionate 0.025% formulation 5, or 13, or 0.05% cream; twice daily for 28 days. Safety endpoints included adrenocorticotropic hormone (ACTH) test results at day 28 (primary), and local tolerability at each visit (burning/stinging/pruritus, secondary). Efficacy endpoints included Psoriasis Global Assessment (PGA) score. Results: Overall, 88 patients received clobetasol propionate 0.025% formulation 5 and 13 (n = 29 for both) and 0.05% cream (n = 30). At day 28, the proportion of patients with an abnormal ACTH stimulation test (cortisol levels B 18 lg/dl) was numerically lower in 0.025% formulations: 5 (20.7%) and 13 (17.2%) compared with 0.05% cream (30.0%), (p = 0.320). Decrease in burning/stinging /pruritus scores were comparable in all treatment groups and PGA success rates were higher with 0.025% formulations: 5 (38.9%) and 13 (36.8%) compared with 0.05% cream (30.8%). Conclusion: Clobetasol propionate 0.025% could be an effective treatment for moderate-tosevere psoriasis compared with 0.05% cream,

Topical clobetasol propionate 0.025%: a therapeutic dermatologic asset

“…The global prevalence of psoriasis ranges from 0.09-11.43%, resulting in a high global burden that significantly hampers the quality of life. 3 Since the introduction of TCs, they serve a central position in the management of various skin disorders such as psoriasis, contact dermatitis, seborrheic dermatitis, atopic dermatitis, and other inflammatory dermatological conditions. 1 Class 1 TCs are prescribed by dermatologists for the treatment of plaque psoriasis in approximately 60% of the patients.…”

“…Thus, the development of improved formulations containing half the concentration of conventional CP (0.025%) without compromising on the therapeutic potential and safety will cater to the unmet needs. 3 The success or failure of a TC is largely impacted by vehicle formulation and patient preference, along with its potency and anticipated efficacy. CP 0.025% is class I TC developed as a cream formulation without propylene glycol, ethanol, and a sorbitol-based emulsifier like sorbitan sesquioleate, which is a contact allergen and a common component in several TC formulations, including the CP 0.05% ointment.…”

Clobetasol propionate 0.025% cream in the management of steroid responsive dermatoses: an expert opinion

“…The results of the study revealed that PGA success rates (clear or almost clear), at the end of the treatment, were higher with 0.025% formulations and were as follows: 5 (38.9%) and 13 (36.8%) versus 0.05% cream (30.8%). 8 In another phase II study conducted in United States, Draelos et al compared the efficacy of CP 0.025% cream versus CP 0.05% cream in patients (≥18 years) with a clinical diagnosis of stable (at least 3 months) plaquetype psoriasis, that involved 20% to 50% of the BSA (Investigator Global Assessment (IGA) grade of at least 3). The patients used either CP 0.025% cream or CP 0.05% cream for 15 consecutive days.…”

Clobetasol propionate 0.025%: a topical therapeutic for skin diseases

“…CP is the strongest topical steroid approved for use. 2 It inhibits cytokine production and has anti-inflammatory, immunosuppressive, and antimitotic activities. It also alters the growth, differentiation, and function of diverse cells.…”