Two Multicenter, Randomized, Double-Blind, Parallel Group Comparison Studies of a Novel Enhanced Lotion Formulation of Halobetasol Propionate, 0.05% Versus Its Vehicle in Adult Subjects With Plaque Psoriasis.

BACKGROUND: A novel lotion formulation of halobetasol propionate, 0.05% (HBP Lotion) with enhanced vehicle characteristics of a cream while preserving the ease of use and cosmetic elegance of a lotion has been developed to treat plaque psoriasis. OBJECTIVE: Determine the safety and effectiveness of HBP Lotion in patients with plaque psoriasis. METHODS: Two prospective, randomized, vehicle-controlled clinical studies were conducted in 443 adult subjects with moderate-severe plaque psoriasis. Subjects applied the test article to psoriatic plaques within the treatment area twice daily for 14 days. Efficacy data are based upon treatment "success" defined as those subjects that achieved scores of 0=clear or 1=almost clear with at least a two-grade improvement relative to baseline for an Investigator's Global Assessment (IGA) and clinical signs (plaque elevation, erythema, scaling). Safety data are presented as adverse events and local skin reactions. RESULTS: After two weeks of treatment with HBP Lotion, 44.5% of the HBP Lotion treated subjects in each study achieved (a) treatment "success" (ie, an IGA score of 0=clear or 1=almost clear and >2 grade improvement compared to baseline) and (b) a notable reduction in plaque elevation, erythema, scaling, and pruritus. In contrast, only 6.3% and 7.1% of VEH subjects in Studies 1 and 2, respectively, achieved treatment success and the reduction of disease related signs was materially lower. Statistically, at day 15 in both Phase 3 studies, treatment success with HBP Lotion was superior to VEH (P less than 0.001). From a safety perspective the outcomes were in general unremarkable with similar findings in the HBP Lotion and VEH treatment groups. CONCLUSIONS: The results demonstrate the safety and effectiveness of HBP Lotion in the treatment of plaque psoriasis. Furthermore, this novel HBP lotion formulation is also distinguished by its moisturization qualities and ease of use.

J Drugs Dermatol. 2017;16(3):234-240.

Evaluation of adrenal suppression of a lipid enhanced, topical emollient cream formulation of hydrocortisone butyrate 0.1% in treating children with atopic dermatitis.

Corticosteroids are currently the first line of treatment for patients with atopic dermatitis. In the pediatric population however, the potential impact of adrenal suppression is always an important safety concern. Twenty boys and girls, 5-12 years of age, with normal adrenal function and a history of atopic dermatitis were maximally treated three times daily with a lipid-rich, moisturizing formulation of hydrocortisone butyrate 0.1% for up to 4 weeks. At the conclusion of the 4-week treatment period, cosyntropin injection stimulation testing showed no evidence of adrenal suppression. In addition, the therapy was noted to be highly efficacious, with a clinical success rate of 80% (Physician Global Score of (0) clear or (1) almost clear). No local side effects associated with prolonged use of topical corticosteroids were reported. In summary, this study supports the contention that this lipid-rich, moisturizing formulation of hydrocortisone butyrate 0.1% was a well-tolerated and beneficial treatment for atopic dermatitis, demonstrating no adrenal suppression in the pediatric population aged 5-12 years. The relevance of these findings for children below 5 years of age, because of difference in body mass/surface area ratios, remains to be determined.

Actinic keratoses and the incidence of occult squamous cell carcinoma: a clinical-histopathologic correlation.

BACKGROUND: The ability to clinically diagnose actinic keratoses (AKs) lesions has been taken for granted for some time. The importance of the malignant potential of these lesions is well known. However, a recent Phase IV, multicenter study assessing the long-term benefit of aminolevulinic acid-based photodynamic therapy provided a unique opportunity to prospectively examine the clinical histopathologic correlation of AKs. OBJECTIVE: The objective was to characterize the histopathology of clinically diagnosed AK lesions in the study population. METHODS: Punch biopsies of 220 clinically diagnosed untreated AKs were performed at baseline plus 51 lesions unresponsive to treatment (total, 271). RESULTS: Clinical diagnosis and histopathologic findings agreed in 91% (246/271) of the lesions biopsied. The balance of the biopsied lesions were: (1) benign changes 4% (11/271) and (2) occult cutaneous malignancy in 5% (14/271) of the cases, 12 squamous cell carcinomas and 2 basal cell carcinomas. CONCLUSIONS: In this study, about 1 in 25 clinically diagnosed AK lesions identified by board-certified dermatologist investigator(s) were occult early-stage squamous cell carcinomas on histologic assessment, a fact surmised by the medical community that until now had not been well quantified. These findings should be considered when clinicians decide how to treat and manage AK patients.