Efficacy and safety of crisaborole ointment, 2%, in participants aged ≥45 years with stasis dermatitis : Results from a fully decentralized, randomized, proof-of-concept phase 2a study
Copyright © 2024 American Academy of Dermatology, Inc. Published by Elsevier Inc. All rights reserved..
BACKGROUND: Crisaborole ointment, 2%, is a nonsteroidal topical phosphodiesterase 4 inhibitor approved for the treatment of mild-to-moderate atopic dermatitis.
OBJECTIVE: To evaluate the efficacy and safety of crisaborole in stasis dermatitis (SD).
METHODS: In this randomized, double-blind, vehicle-controlled, decentralized phase 2a study (NCT04091087), 65 participants aged ≥45 years with SD without active ulceration received crisaborole or vehicle (1:1) twice-daily for 6 weeks. The primary end point was percentage change from baseline in total sign score at week 6 based on in-person assessment.
RESULTS: Crisaborole-treated participants had significantly reduced total sign score from baseline versus vehicle based on in-person (nondermatologist) assessment (-32.4% vs -18.1%, P = .0299) and central reader (dermatologists) assessment of photographs (-52.5% vs -10.3%, P = .0004). Efficacy according to success and improvement per Investigator's Global Assessment score and lesional percentage body surface area reached statistical significance based on central reader but not in-person assessments. Skin and subcutaneous tissue disorders were common all-causality treatment-emergent adverse events with crisaborole.
LIMITATIONS: Small sample size and short treatment duration were key limitations. In-person assessment was not conducted by dermatologists.
CONCLUSION: Crisaborole improved signs and symptoms of SD and was well tolerated. Central reader assessment represents a promising approach for siteless clinical research.
| Medienart: |
E-Artikel |
|---|
| Erscheinungsjahr: |
2024 |
|---|---|
| Erschienen: |
2024 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:90 |
|---|---|
| Enthalten in: |
Journal of the American Academy of Dermatology - 90(2024), 5 vom: 01. Apr., Seite 945-952 |
| Sprache: |
Englisch |
|---|
| Beteiligte Personen: |
Silverberg, Jonathan I [VerfasserIn] |
|---|
| Links: |
|---|
| Anmerkungen: |
Date Completed 15.04.2024 Date Revised 18.04.2024 published: Print-Electronic Citation Status MEDLINE |
|---|
| doi: |
10.1016/j.jaad.2023.12.048 |
|---|
| funding: |
|
|---|---|
| Förderinstitution / Projekttitel: |
|
| PPN (Katalog-ID): |
NLM368296393 |
|---|
| LEADER | 01000caa a22002652 4500 | ||
|---|---|---|---|
| 001 | NLM368296393 | ||
| 003 | DE-627 | ||
| 005 | 20240419232307.0 | ||
| 007 | cr uuu---uuuuu | ||
| 008 | 240211s2024 xx |||||o 00| ||eng c | ||
| 024 | 7 | |a 10.1016/j.jaad.2023.12.048 |2 doi | |
| 028 | 5 | 2 | |a pubmed24n1380.xml |
| 035 | |a (DE-627)NLM368296393 | ||
| 035 | |a (NLM)38340127 | ||
| 035 | |a (PII)S0190-9622(24)00052-5 | ||
| 040 | |a DE-627 |b ger |c DE-627 |e rakwb | ||
| 041 | |a eng | ||
| 100 | 1 | |a Silverberg, Jonathan I |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Efficacy and safety of crisaborole ointment, 2%, in participants aged ≥45 years with stasis dermatitis |b Results from a fully decentralized, randomized, proof-of-concept phase 2a study |
| 264 | 1 | |c 2024 | |
| 336 | |a Text |b txt |2 rdacontent | ||
| 337 | |a ƒaComputermedien |b c |2 rdamedia | ||
| 338 | |a ƒa Online-Ressource |b cr |2 rdacarrier | ||
| 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: Crisaborole ointment, 2%, is a nonsteroidal topical phosphodiesterase 4 inhibitor approved for the treatment of mild-to-moderate atopic dermatitis | ||
| 520 | |a OBJECTIVE: To evaluate the efficacy and safety of crisaborole in stasis dermatitis (SD) | ||
| 520 | |a METHODS: In this randomized, double-blind, vehicle-controlled, decentralized phase 2a study (NCT04091087), 65 participants aged ≥45 years with SD without active ulceration received crisaborole or vehicle (1:1) twice-daily for 6 weeks. The primary end point was percentage change from baseline in total sign score at week 6 based on in-person assessment | ||
| 520 | |a RESULTS: Crisaborole-treated participants had significantly reduced total sign score from baseline versus vehicle based on in-person (nondermatologist) assessment (-32.4% vs -18.1%, P = .0299) and central reader (dermatologists) assessment of photographs (-52.5% vs -10.3%, P = .0004). Efficacy according to success and improvement per Investigator's Global Assessment score and lesional percentage body surface area reached statistical significance based on central reader but not in-person assessments. Skin and subcutaneous tissue disorders were common all-causality treatment-emergent adverse events with crisaborole | ||
| 520 | |a LIMITATIONS: Small sample size and short treatment duration were key limitations. In-person assessment was not conducted by dermatologists | ||
| 520 | |a CONCLUSION: Crisaborole improved signs and symptoms of SD and was well tolerated. Central reader assessment represents a promising approach for siteless clinical research | ||
| 650 | 4 | |a Randomized Controlled Trial | |
| 650 | 4 | |a Clinical Trial, Phase II | |
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a chronic venous insufficiency | |
| 650 | 4 | |a crisaborole | |
| 650 | 4 | |a decentralized study | |
| 650 | 4 | |a phosphodiesterase-4 inhibitor | |
| 650 | 4 | |a pruritus | |
| 650 | 4 | |a stasis dermatitis | |
| 650 | 4 | |a topical ointment | |
| 650 | 4 | |a total sign score | |
| 650 | 7 | |a Boron Compounds |2 NLM | |
| 650 | 7 | |a Bridged Bicyclo Compounds, Heterocyclic |2 NLM | |
| 650 | 7 | |a crisaborole |2 NLM | |
| 650 | 7 | |a Q2R47HGR7P |2 NLM | |
| 650 | 7 | |a Ointments |2 NLM | |
| 700 | 1 | |a Kirsner, Robert S |e verfasserin |4 aut | |
| 700 | 1 | |a Margolis, David J |e verfasserin |4 aut | |
| 700 | 1 | |a Tharp, Michael |e verfasserin |4 aut | |
| 700 | 1 | |a Myers, Daniela E |e verfasserin |4 aut | |
| 700 | 1 | |a Annis, Karen |e verfasserin |4 aut | |
| 700 | 1 | |a Graham, Daniela |e verfasserin |4 aut | |
| 700 | 1 | |a Zang, Chuanbo |e verfasserin |4 aut | |
| 700 | 1 | |a Vlahos, Bonnie L |e verfasserin |4 aut | |
| 700 | 1 | |a Sanders, Paul |e verfasserin |4 aut | |
| 773 | 0 | 8 | |i Enthalten in |t Journal of the American Academy of Dermatology |d 1984 |g 90(2024), 5 vom: 01. Apr., Seite 945-952 |w (DE-627)NLM000422703 |x 1097-6787 |7 nnns |
| 773 | 1 | 8 | |g volume:90 |g year:2024 |g number:5 |g day:01 |g month:04 |g pages:945-952 |
| 856 | 4 | 0 | |u http://dx.doi.org/10.1016/j.jaad.2023.12.048 |3 Volltext |
| 912 | |a GBV_USEFLAG_A | ||
| 912 | |a GBV_NLM | ||
| 951 | |a AR | ||
| 952 | |d 90 |j 2024 |e 5 |b 01 |c 04 |h 945-952 | ||