A phase 2, multicenter, double-blind, randomized, vehicle-controlled clinical study to compare the safety and efficacy of a halobetasol propionate 0.01% lotion and halobetasol propionate 0.05% cream in the treatment of plaque psoriasis
Background: Halobetasol propionate (HP) 0.05% is a highly effective short-term treatment for plaque psoriasis. Objective: Compare efficacy and safety of once-daily HP 0.01% lotion and 0.05% cream (Ultravate®) in moderate-to-severe psoriasis. Methods: Multicenter, randomized, double-blind, vehicle-co...
| Main Authors: | , , , , |
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| Format: | Article |
| Language: | English |
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Taylor & Francis Group
2019-05-01
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| Series: | Journal of Dermatological Treatment |
| Subjects: | |
| Online Access: | http://dx.doi.org/10.1080/09546634.2018.1523362 |
| _version_ | 1797683715384541184 |
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| author | Francisco A. Kerdel Zoe D. Draelos Stephen K. Tyring Tina Lin Radhakrishnan Pillai |
| author_facet | Francisco A. Kerdel Zoe D. Draelos Stephen K. Tyring Tina Lin Radhakrishnan Pillai |
| author_sort | Francisco A. Kerdel |
| collection | DOAJ |
| description | Background: Halobetasol propionate (HP) 0.05% is a highly effective short-term treatment for plaque psoriasis. Objective: Compare efficacy and safety of once-daily HP 0.01% lotion and 0.05% cream (Ultravate®) in moderate-to-severe psoriasis. Methods: Multicenter, randomized, double-blind, vehicle-controlled Phase 2 study (N = 150). Patients randomized to HP 0.01% lotion, HP 0.05% cream, or vehicle, once-daily for 2 weeks. Efficacy assessments included treatment success; impact on erythema, plaque elevation, and scaling; and improvement in body surface area (BSA). Safety and treatment-emergent adverse events (TEAEs) were evaluated throughout. Results: 30.0% and 31.6% of patients were treatment successes with HP 0.01% lotion and HP 0.05% cream (p = .854). A 2-grade improvement in erythema, plaque elevation and scaling was achieved in 38.3%, 40.0%, and 43.3% of patients, compared with 31.6% (p = .446), 36.8% (p = .727), and 47.4% (p = .663) on HP 0.05% cream. BSA improved by 22.3% with HP 0.01% lotion compared with 20.9% (p = .787). There was one treatment-related application-site reaction with HP 0.01% lotion, and no AE reports of skin atrophy, striae, telangiectasia, or folliculitis. Conclusions: Halobetasol propionate 0.01% lotion was comparable to the higher concentration halobetasol propionate 0.05% cream; achieving treatment success, reducing psoriasis signs at the target lesion, and improving BSA following two weeks’ daily-treatment. Both treatments were well-tolerated. Clinical Trials Registration: clinicaltrials.gov NCT02785185 |
| first_indexed | 2024-03-12T00:19:46Z |
| format | Article |
| id | doaj.art-f640e166c3654efd9aa94eb458ad2b8a |
| institution | Directory Open Access Journal |
| issn | 0954-6634 1471-1753 |
| language | English |
| last_indexed | 2024-03-12T00:19:46Z |
| publishDate | 2019-05-01 |
| publisher | Taylor & Francis Group |
| record_format | Article |
| series | Journal of Dermatological Treatment |
| spelling | doaj.art-f640e166c3654efd9aa94eb458ad2b8a2023-09-15T14:08:33ZengTaylor & Francis GroupJournal of Dermatological Treatment0954-66341471-17532019-05-0130433333910.1080/09546634.2018.15233621523362A phase 2, multicenter, double-blind, randomized, vehicle-controlled clinical study to compare the safety and efficacy of a halobetasol propionate 0.01% lotion and halobetasol propionate 0.05% cream in the treatment of plaque psoriasisFrancisco A. Kerdel0Zoe D. Draelos1Stephen K. Tyring2Tina Lin3Radhakrishnan Pillai4Florida Academic Dermatology Centers Research and Education LLCDermatology Consulting ServicesUniversity of Texas Health Science CenterOrtho DermatologicsDow Pharmaceutical Sciences Inc.Background: Halobetasol propionate (HP) 0.05% is a highly effective short-term treatment for plaque psoriasis. Objective: Compare efficacy and safety of once-daily HP 0.01% lotion and 0.05% cream (Ultravate®) in moderate-to-severe psoriasis. Methods: Multicenter, randomized, double-blind, vehicle-controlled Phase 2 study (N = 150). Patients randomized to HP 0.01% lotion, HP 0.05% cream, or vehicle, once-daily for 2 weeks. Efficacy assessments included treatment success; impact on erythema, plaque elevation, and scaling; and improvement in body surface area (BSA). Safety and treatment-emergent adverse events (TEAEs) were evaluated throughout. Results: 30.0% and 31.6% of patients were treatment successes with HP 0.01% lotion and HP 0.05% cream (p = .854). A 2-grade improvement in erythema, plaque elevation and scaling was achieved in 38.3%, 40.0%, and 43.3% of patients, compared with 31.6% (p = .446), 36.8% (p = .727), and 47.4% (p = .663) on HP 0.05% cream. BSA improved by 22.3% with HP 0.01% lotion compared with 20.9% (p = .787). There was one treatment-related application-site reaction with HP 0.01% lotion, and no AE reports of skin atrophy, striae, telangiectasia, or folliculitis. Conclusions: Halobetasol propionate 0.01% lotion was comparable to the higher concentration halobetasol propionate 0.05% cream; achieving treatment success, reducing psoriasis signs at the target lesion, and improving BSA following two weeks’ daily-treatment. Both treatments were well-tolerated. Clinical Trials Registration: clinicaltrials.gov NCT02785185http://dx.doi.org/10.1080/09546634.2018.1523362psoriasistopicalhalobetasolclinical trial |
| spellingShingle | Francisco A. Kerdel Zoe D. Draelos Stephen K. Tyring Tina Lin Radhakrishnan Pillai A phase 2, multicenter, double-blind, randomized, vehicle-controlled clinical study to compare the safety and efficacy of a halobetasol propionate 0.01% lotion and halobetasol propionate 0.05% cream in the treatment of plaque psoriasis Journal of Dermatological Treatment psoriasis topical halobetasol clinical trial |
| title | A phase 2, multicenter, double-blind, randomized, vehicle-controlled clinical study to compare the safety and efficacy of a halobetasol propionate 0.01% lotion and halobetasol propionate 0.05% cream in the treatment of plaque psoriasis |
| title_full | A phase 2, multicenter, double-blind, randomized, vehicle-controlled clinical study to compare the safety and efficacy of a halobetasol propionate 0.01% lotion and halobetasol propionate 0.05% cream in the treatment of plaque psoriasis |
| title_fullStr | A phase 2, multicenter, double-blind, randomized, vehicle-controlled clinical study to compare the safety and efficacy of a halobetasol propionate 0.01% lotion and halobetasol propionate 0.05% cream in the treatment of plaque psoriasis |
| title_full_unstemmed | A phase 2, multicenter, double-blind, randomized, vehicle-controlled clinical study to compare the safety and efficacy of a halobetasol propionate 0.01% lotion and halobetasol propionate 0.05% cream in the treatment of plaque psoriasis |
| title_short | A phase 2, multicenter, double-blind, randomized, vehicle-controlled clinical study to compare the safety and efficacy of a halobetasol propionate 0.01% lotion and halobetasol propionate 0.05% cream in the treatment of plaque psoriasis |
| title_sort | phase 2 multicenter double blind randomized vehicle controlled clinical study to compare the safety and efficacy of a halobetasol propionate 0 01 lotion and halobetasol propionate 0 05 cream in the treatment of plaque psoriasis |
| topic | psoriasis topical halobetasol clinical trial |
| url | http://dx.doi.org/10.1080/09546634.2018.1523362 |
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