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

• Published in: Dermatology and therapy Vol. 11; no. 5; pp. 1717 - 1732
• Main Authors: Sidgiddi, Srinivas, Naqvi, Syed Mujtaba Hussain, Shenoy, Manjunath, Balraj, Devang Narayan, Kothari, Jayesh, Gupta, Sandesh, Haq, Rizwan, Mittal, Rajan, Mehta, Suyog, Mane, Amey
• Format: Journal Article
• Language: English
• Published: Cheshire Springer Healthcare 01.10.2021; Springer
• Subjects: Clobetasol; Dermatologic agents; Dermatology; Drug therapy; Formulae, receipts, prescriptions; Internal Medicine; Medicine; Medicine & Public Health; Oral and Maxillofacial Surgery; Original Research; Plastic Surgery; Psoriasis; Quality of Life Research; REF; REF/2018/01/016779; Testing; India; Hypothalamic–pituitary–adrenal axis suppression; Psoriasis Global Assessment; Clobetasol propionate 0.025; Novel formulation; Clobetasol propionate 0.05; Moderate-to-severe psoriasis
• ISSN: 2193-8210; 2190-9172
• DOI: 10.1007/s13555-021-00591-z

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 ≥ 18 years with moderate-to-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 ≤ 18 µg/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-to-severe psoriasis compared with 0.05% cream, demonstrating comparable efficacy with a better systemic safety profile. Trial Registration Number REF/2018/01/016779.