Halobetasol propionate lotion 0.05% in patients 12 to 16 years 11 months of age with plaque psoriasis: Results of an open-label study evaluating adrenal suppression potentialCapsule Summary
Background: The effects of halobetasol propionate (HBP) lotion 0.05% on the hypothalamic-pituitary-adrenal (HPA) axis have not been previously evaluated in adolescents. Objective: To examine the effect of HBP on HPA axis suppression in patients aged <17 years with plaque psoriasis. Methods: In th...
Guardado en:
| Autores principales: | , , , |
|---|---|
| Formato: | article |
| Lenguaje: | EN |
| Publicado: |
Elsevier
2022
|
| Materias: | |
| Acceso en línea: | https://doaj.org/article/9b2fd133847845d3a895f520e3ec634f |
| Etiquetas: |
Agregar Etiqueta
Sin Etiquetas, Sea el primero en etiquetar este registro!
|
| id |
oai:doaj.org-article:9b2fd133847845d3a895f520e3ec634f |
|---|---|
| record_format |
dspace |
| spelling |
oai:doaj.org-article:9b2fd133847845d3a895f520e3ec634f2021-11-26T04:40:53ZHalobetasol propionate lotion 0.05% in patients 12 to 16 years 11 months of age with plaque psoriasis: Results of an open-label study evaluating adrenal suppression potentialCapsule Summary2666-328710.1016/j.jdin.2021.10.003https://doaj.org/article/9b2fd133847845d3a895f520e3ec634f2022-03-01T00:00:00Zhttp://www.sciencedirect.com/science/article/pii/S2666328721000821https://doaj.org/toc/2666-3287Background: The effects of halobetasol propionate (HBP) lotion 0.05% on the hypothalamic-pituitary-adrenal (HPA) axis have not been previously evaluated in adolescents. Objective: To examine the effect of HBP on HPA axis suppression in patients aged <17 years with plaque psoriasis. Methods: In this phase 4, open-label, multicenter study, patients aged 12 to 16 years 11 months with stable plaque psoriasis covering ≥10% of their body surface area were enrolled. The patients applied an HBP lotion twice daily for up to 2 weeks. The cosyntropin stimulation test was used to determine cortisol levels at the time of screening and at the end of the study to evaluate HPA axis response. The additional endpoints included adverse events, disease severity (measured using Investigator Global Assessment score), and percent body surface area affected. Results: Sixteen patients were enrolled and included in the safety population; 14 were included in the evaluable population. One patient exhibited an abnormal HPA axis response (16.2 μg/dL) at the end of the study; the response returned to normal at the 6-month follow-up visit. By the end of the study, the Investigator Global Assessment score improved by ≥1 point in most patients; moreover, the percent body surface area affected decreased from 11.5% to 2.8%. One mild adverse event was possibly related to the HBP lotion; however, it resolved and did not cause study discontinuation. Limitations: Small sample size. Conclusion: The HBP lotion 0.05% appeared efficacious and well tolerated in patients as young as 12 years old.Vivian Laquer, MDAndrea Nguyen, PA-C, MSNicholas Squittieri, MDTien Nguyen, MDElsevierarticleadolescentadrenal suppressioncorticosteroidshalobetasol propionatepharmacologypsoriasisDermatologyRL1-803ENJAAD International, Vol 6, Iss , Pp 13-19 (2022) |
| institution |
DOAJ |
| collection |
DOAJ |
| language |
EN |
| topic |
adolescent adrenal suppression corticosteroids halobetasol propionate pharmacology psoriasis Dermatology RL1-803 |
| spellingShingle |
adolescent adrenal suppression corticosteroids halobetasol propionate pharmacology psoriasis Dermatology RL1-803 Vivian Laquer, MD Andrea Nguyen, PA-C, MS Nicholas Squittieri, MD Tien Nguyen, MD Halobetasol propionate lotion 0.05% in patients 12 to 16 years 11 months of age with plaque psoriasis: Results of an open-label study evaluating adrenal suppression potentialCapsule Summary |
| description |
Background: The effects of halobetasol propionate (HBP) lotion 0.05% on the hypothalamic-pituitary-adrenal (HPA) axis have not been previously evaluated in adolescents. Objective: To examine the effect of HBP on HPA axis suppression in patients aged <17 years with plaque psoriasis. Methods: In this phase 4, open-label, multicenter study, patients aged 12 to 16 years 11 months with stable plaque psoriasis covering ≥10% of their body surface area were enrolled. The patients applied an HBP lotion twice daily for up to 2 weeks. The cosyntropin stimulation test was used to determine cortisol levels at the time of screening and at the end of the study to evaluate HPA axis response. The additional endpoints included adverse events, disease severity (measured using Investigator Global Assessment score), and percent body surface area affected. Results: Sixteen patients were enrolled and included in the safety population; 14 were included in the evaluable population. One patient exhibited an abnormal HPA axis response (16.2 μg/dL) at the end of the study; the response returned to normal at the 6-month follow-up visit. By the end of the study, the Investigator Global Assessment score improved by ≥1 point in most patients; moreover, the percent body surface area affected decreased from 11.5% to 2.8%. One mild adverse event was possibly related to the HBP lotion; however, it resolved and did not cause study discontinuation. Limitations: Small sample size. Conclusion: The HBP lotion 0.05% appeared efficacious and well tolerated in patients as young as 12 years old. |
| format |
article |
| author |
Vivian Laquer, MD Andrea Nguyen, PA-C, MS Nicholas Squittieri, MD Tien Nguyen, MD |
| author_facet |
Vivian Laquer, MD Andrea Nguyen, PA-C, MS Nicholas Squittieri, MD Tien Nguyen, MD |
| author_sort |
Vivian Laquer, MD |
| title |
Halobetasol propionate lotion 0.05% in patients 12 to 16 years 11 months of age with plaque psoriasis: Results of an open-label study evaluating adrenal suppression potentialCapsule Summary |
| title_short |
Halobetasol propionate lotion 0.05% in patients 12 to 16 years 11 months of age with plaque psoriasis: Results of an open-label study evaluating adrenal suppression potentialCapsule Summary |
| title_full |
Halobetasol propionate lotion 0.05% in patients 12 to 16 years 11 months of age with plaque psoriasis: Results of an open-label study evaluating adrenal suppression potentialCapsule Summary |
| title_fullStr |
Halobetasol propionate lotion 0.05% in patients 12 to 16 years 11 months of age with plaque psoriasis: Results of an open-label study evaluating adrenal suppression potentialCapsule Summary |
| title_full_unstemmed |
Halobetasol propionate lotion 0.05% in patients 12 to 16 years 11 months of age with plaque psoriasis: Results of an open-label study evaluating adrenal suppression potentialCapsule Summary |
| title_sort |
halobetasol propionate lotion 0.05% in patients 12 to 16 years 11 months of age with plaque psoriasis: results of an open-label study evaluating adrenal suppression potentialcapsule summary |
| publisher |
Elsevier |
| publishDate |
2022 |
| url |
https://doaj.org/article/9b2fd133847845d3a895f520e3ec634f |
| work_keys_str_mv |
AT vivianlaquermd halobetasolpropionatelotion005inpatients12to16years11monthsofagewithplaquepsoriasisresultsofanopenlabelstudyevaluatingadrenalsuppressionpotentialcapsulesummary AT andreanguyenpacms halobetasolpropionatelotion005inpatients12to16years11monthsofagewithplaquepsoriasisresultsofanopenlabelstudyevaluatingadrenalsuppressionpotentialcapsulesummary AT nicholassquittierimd halobetasolpropionatelotion005inpatients12to16years11monthsofagewithplaquepsoriasisresultsofanopenlabelstudyevaluatingadrenalsuppressionpotentialcapsulesummary AT tiennguyenmd halobetasolpropionatelotion005inpatients12to16years11monthsofagewithplaquepsoriasisresultsofanopenlabelstudyevaluatingadrenalsuppressionpotentialcapsulesummary |
| _version_ |
1718409795680075776 |