Roflumilast foam 0.3% for adolescent and adult patients with seborrheic dermatitis : A randomized, double-blinded, vehicle-controlled, phase 3 trial
Copyright © 2024 American Academy of Dermatology, Inc. Published by Elsevier Inc. All rights reserved..
BACKGROUND: The topical phosphodiesterase 4 inhibitor roflumilast has been studied in several dermatologic conditions.
OBJECTIVE: Roflumilast foam 0.3% is being investigated as a topical treatment for seborrheic dermatitis (SD).
METHODS: In this phase 3, double-blinded trial, patients with SD were randomly assigned (2:1 ratio) to once-daily roflumilast foam 0.3% or vehicle foam for 8 weeks. The primary efficacy outcome was Investigator Global Assessment (IGA) Success at week 8, defined as IGA of 0 (Clear) or 1 (Almost Clear) plus ≥2-point improvement from baseline. Safety was also assessed.
RESULTS: 79.5% of roflumilast-treated and 58.0% of vehicle-treated patients met the primary endpoint (P < .001); statistically significant differences in IGA Success also favored roflumilast at week 2 (roflumilast: 43.0%; vehicle: 25.7%; P < .001) and week 4 (roflumilast: 73.1%; vehicle: 47.1%; P < .001). Roflumilast was well-tolerated with a low rate of treatment-emergent adverse events.
LIMITATIONS: Study limitations include the 8-week treatment period for this chronic condition.
CONCLUSIONS: Once-daily roflumilast foam was superior to vehicle in leading to IGA of Clear or Almost Clear plus ≥2-point improvement from baseline at 8 weeks in patients with SD. Longer trials are needed to determine durability and safety of roflumilast foam in SD.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2024 |
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| Erschienen: |
2024 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:90 |
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| Enthalten in: |
Journal of the American Academy of Dermatology - 90(2024), 5 vom: 18. Apr., Seite 986-993 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Blauvelt, Andrew [VerfasserIn] |
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| Links: |
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| Anmerkungen: |
Date Completed 15.04.2024 Date Revised 18.04.2024 published: Print-Electronic Citation Status MEDLINE |
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| doi: |
10.1016/j.jaad.2023.12.065 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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NLM367436159 |
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| 100 | 1 | |a Blauvelt, Andrew |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Roflumilast foam 0.3% for adolescent and adult patients with seborrheic dermatitis |b A randomized, double-blinded, vehicle-controlled, phase 3 trial |
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| 500 | |a Date Completed 15.04.2024 | ||
| 500 | |a Date Revised 18.04.2024 | ||
| 500 | |a published: Print-Electronic | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a Copyright © 2024 American Academy of Dermatology, Inc. Published by Elsevier Inc. All rights reserved. | ||
| 520 | |a BACKGROUND: The topical phosphodiesterase 4 inhibitor roflumilast has been studied in several dermatologic conditions | ||
| 520 | |a OBJECTIVE: Roflumilast foam 0.3% is being investigated as a topical treatment for seborrheic dermatitis (SD) | ||
| 520 | |a METHODS: In this phase 3, double-blinded trial, patients with SD were randomly assigned (2:1 ratio) to once-daily roflumilast foam 0.3% or vehicle foam for 8 weeks. The primary efficacy outcome was Investigator Global Assessment (IGA) Success at week 8, defined as IGA of 0 (Clear) or 1 (Almost Clear) plus ≥2-point improvement from baseline. Safety was also assessed | ||
| 520 | |a RESULTS: 79.5% of roflumilast-treated and 58.0% of vehicle-treated patients met the primary endpoint (P < .001); statistically significant differences in IGA Success also favored roflumilast at week 2 (roflumilast: 43.0%; vehicle: 25.7%; P < .001) and week 4 (roflumilast: 73.1%; vehicle: 47.1%; P < .001). Roflumilast was well-tolerated with a low rate of treatment-emergent adverse events | ||
| 520 | |a LIMITATIONS: Study limitations include the 8-week treatment period for this chronic condition | ||
| 520 | |a CONCLUSIONS: Once-daily roflumilast foam was superior to vehicle in leading to IGA of Clear or Almost Clear plus ≥2-point improvement from baseline at 8 weeks in patients with SD. Longer trials are needed to determine durability and safety of roflumilast foam in SD | ||
| 650 | 4 | |a Randomized Controlled Trial | |
| 650 | 4 | |a Clinical Trial, Phase III | |
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a STRATUM | |
| 650 | 4 | |a phase 3 | |
| 650 | 4 | |a phosphodiesterase 4 inhibitor | |
| 650 | 4 | |a randomized controlled trial | |
| 650 | 4 | |a roflumilast foam 0.3% | |
| 650 | 4 | |a seborrheic dermatitis | |
| 650 | 7 | |a Roflumilast |2 NLM | |
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| 650 | 7 | |a Aminopyridines |2 NLM | |
| 650 | 7 | |a Immunoglobulin A |2 NLM | |
| 650 | 7 | |a Benzamides |2 NLM | |
| 650 | 7 | |a Cyclopropanes |2 NLM | |
| 700 | 1 | |a Draelos, Zoe D |e verfasserin |4 aut | |
| 700 | 1 | |a Stein Gold, Linda |e verfasserin |4 aut | |
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| 700 | 1 | |a Gooderham, Melinda |e verfasserin |4 aut | |
| 700 | 1 | |a Green, Lawrence |e verfasserin |4 aut | |
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| 700 | 1 | |a Lain, Edward |e verfasserin |4 aut | |
| 700 | 1 | |a Moore, Angela Y |e verfasserin |4 aut | |
| 700 | 1 | |a Papp, Kim A |e verfasserin |4 aut | |
| 700 | 1 | |a Zirwas, Matthew |e verfasserin |4 aut | |
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