1.Crisaborole 2% for Pediatric Periorificial Dermatitis: A Randomized, Double-Blind, Vehicle-Controlled Pilot Study
Ayelet OLLECH ; Bat-El Bar ALUMA ; Adi WEISS-FINK ; Amir HOREV ; Ori TOKER ; Tali CZARNOWICKI
Annals of Dermatology 2026;38(3):177-182
Background:
Periorificial dermatitis (POD) is a common inflammatory skin condition primarily affecting infants, children, and young women. Novel therapies such as phosphodiesterase 4 (PDE4) inhibitors provide promising non-steroidal anti-inflammatory treatment options.
Objective:
This study evaluated the efficacy and safety of topical crisaborole 2% ointment, a PDE4 inhibitor, for treating pediatric patients with POD.
Methods:
A randomized, double-blind, vehicle-controlled trial included 23 participants aged 3 months to 18 years. Patients were treated with crisaborole 2% ointment or placebo for 4 weeks, followed by a 4-week treatment-free observational period. Primary endpoints were a 50% reduction in the Perioral Dermatitis Severity Index (PODSI) and an Investigator’s Global Assessment (IGA) score of 0 or 1 by day 14. Assessments were also conducted on days 29 and 58. Secondary measures included changes in Quality-of-Life Index scores over time and safety evaluations.
Results:
Both groups demonstrated improvement in PODSI and IGA scores during treatment.Although a small, non-significant numerical trend favored the crisaborole group across primary and secondary endpoints, no statistically significant differences between crisaborole and placebo were observed at any time point. Mild burning or stinging were reported more frequently in the crisaborole group, but they were generally tolerable.
Conclusion
While there was a modest numerical trend favoring crisaborole, its efficacy was not statistically superior to placebo in this small pilot study. Larger studies are needed to further validate the efficacy of crisaborole for the treatment for POD.
2.Utilization of artificial intelligence to triage patients with delayed follow-up of probably benign breast ultrasound findings
Tali AMIR ; Kristen COFFEY ; Jeffrey S REINER ; Varadan SEVILIMEDU ; Victoria L MANGO
Ultrasonography 2025;44(2):145-152
Purpose:
This study aimed to evaluate our institution's experience in using artificial intelligence (AI) decision support (DS) as part of the clinical workflow to triage patients with Breast Imaging Reporting and Data System (BI-RADS) 3 sonographic lesions whose follow-up was delayed during the coronavirus disease 2019 (COVID-19) pandemic, against subsequent imaging and/or pathologic follow-up results.
Methods:
This retrospective study included patients with a BI-RADS category 3 (i.e., probably benign) breast ultrasound assessment from August 2019–December 2019 whose follow-up was delayed during the COVID-19 pandemic and whose breast ultrasounds were re-reviewed using Koios DS Breast AI as part of the clinical workflow for triaging these patients. The output of Koios DS was compared with the true outcome of a presence or absence of breast cancer defined by resolution/stability on imaging follow-up for at least 2 years or pathology results.
Results:
The study included 161 women (mean age, 52 years) with 221 BI-RADS category 3 sonographic lesions. Of the 221 lesions, there were two confirmed cancers (0.9% malignancy rate). Koios DS assessed 112/221 lesions (50.7%) as benign, 42/221 lesions (19.0%) as probably benign, 64/221 lesions (29.0%) as suspicious, and 3/221 lesions (1.4%) as probably malignant. Koios DS had a sensitivity of 100% (2/2; 95% confidence interval [CI], 16% to 100%), specificity of 70% (154/219; 95% CI, 64% to 76%), negative predictive value of 100% (154/154; 95% CI, 98% to 100%), and false-positive rate of 30% (65/219; 95% CI, 24% to 36%).
Conclusion
When many follow-up appointments are delayed, e.g., natural disaster, or scenarios where resources are limited, breast ultrasound AI DS can help triage patients with probably benign breast ultrasounds.
3.Utilization of artificial intelligence to triage patients with delayed follow-up of probably benign breast ultrasound findings
Tali AMIR ; Kristen COFFEY ; Jeffrey S REINER ; Varadan SEVILIMEDU ; Victoria L MANGO
Ultrasonography 2025;44(2):145-152
Purpose:
This study aimed to evaluate our institution's experience in using artificial intelligence (AI) decision support (DS) as part of the clinical workflow to triage patients with Breast Imaging Reporting and Data System (BI-RADS) 3 sonographic lesions whose follow-up was delayed during the coronavirus disease 2019 (COVID-19) pandemic, against subsequent imaging and/or pathologic follow-up results.
Methods:
This retrospective study included patients with a BI-RADS category 3 (i.e., probably benign) breast ultrasound assessment from August 2019–December 2019 whose follow-up was delayed during the COVID-19 pandemic and whose breast ultrasounds were re-reviewed using Koios DS Breast AI as part of the clinical workflow for triaging these patients. The output of Koios DS was compared with the true outcome of a presence or absence of breast cancer defined by resolution/stability on imaging follow-up for at least 2 years or pathology results.
Results:
The study included 161 women (mean age, 52 years) with 221 BI-RADS category 3 sonographic lesions. Of the 221 lesions, there were two confirmed cancers (0.9% malignancy rate). Koios DS assessed 112/221 lesions (50.7%) as benign, 42/221 lesions (19.0%) as probably benign, 64/221 lesions (29.0%) as suspicious, and 3/221 lesions (1.4%) as probably malignant. Koios DS had a sensitivity of 100% (2/2; 95% confidence interval [CI], 16% to 100%), specificity of 70% (154/219; 95% CI, 64% to 76%), negative predictive value of 100% (154/154; 95% CI, 98% to 100%), and false-positive rate of 30% (65/219; 95% CI, 24% to 36%).
Conclusion
When many follow-up appointments are delayed, e.g., natural disaster, or scenarios where resources are limited, breast ultrasound AI DS can help triage patients with probably benign breast ultrasounds.
4.Utilization of artificial intelligence to triage patients with delayed follow-up of probably benign breast ultrasound findings
Tali AMIR ; Kristen COFFEY ; Jeffrey S REINER ; Varadan SEVILIMEDU ; Victoria L MANGO
Ultrasonography 2025;44(2):145-152
Purpose:
This study aimed to evaluate our institution's experience in using artificial intelligence (AI) decision support (DS) as part of the clinical workflow to triage patients with Breast Imaging Reporting and Data System (BI-RADS) 3 sonographic lesions whose follow-up was delayed during the coronavirus disease 2019 (COVID-19) pandemic, against subsequent imaging and/or pathologic follow-up results.
Methods:
This retrospective study included patients with a BI-RADS category 3 (i.e., probably benign) breast ultrasound assessment from August 2019–December 2019 whose follow-up was delayed during the COVID-19 pandemic and whose breast ultrasounds were re-reviewed using Koios DS Breast AI as part of the clinical workflow for triaging these patients. The output of Koios DS was compared with the true outcome of a presence or absence of breast cancer defined by resolution/stability on imaging follow-up for at least 2 years or pathology results.
Results:
The study included 161 women (mean age, 52 years) with 221 BI-RADS category 3 sonographic lesions. Of the 221 lesions, there were two confirmed cancers (0.9% malignancy rate). Koios DS assessed 112/221 lesions (50.7%) as benign, 42/221 lesions (19.0%) as probably benign, 64/221 lesions (29.0%) as suspicious, and 3/221 lesions (1.4%) as probably malignant. Koios DS had a sensitivity of 100% (2/2; 95% confidence interval [CI], 16% to 100%), specificity of 70% (154/219; 95% CI, 64% to 76%), negative predictive value of 100% (154/154; 95% CI, 98% to 100%), and false-positive rate of 30% (65/219; 95% CI, 24% to 36%).
Conclusion
When many follow-up appointments are delayed, e.g., natural disaster, or scenarios where resources are limited, breast ultrasound AI DS can help triage patients with probably benign breast ultrasounds.
5.Utilization of artificial intelligence to triage patients with delayed follow-up of probably benign breast ultrasound findings
Tali AMIR ; Kristen COFFEY ; Jeffrey S REINER ; Varadan SEVILIMEDU ; Victoria L MANGO
Ultrasonography 2025;44(2):145-152
Purpose:
This study aimed to evaluate our institution's experience in using artificial intelligence (AI) decision support (DS) as part of the clinical workflow to triage patients with Breast Imaging Reporting and Data System (BI-RADS) 3 sonographic lesions whose follow-up was delayed during the coronavirus disease 2019 (COVID-19) pandemic, against subsequent imaging and/or pathologic follow-up results.
Methods:
This retrospective study included patients with a BI-RADS category 3 (i.e., probably benign) breast ultrasound assessment from August 2019–December 2019 whose follow-up was delayed during the COVID-19 pandemic and whose breast ultrasounds were re-reviewed using Koios DS Breast AI as part of the clinical workflow for triaging these patients. The output of Koios DS was compared with the true outcome of a presence or absence of breast cancer defined by resolution/stability on imaging follow-up for at least 2 years or pathology results.
Results:
The study included 161 women (mean age, 52 years) with 221 BI-RADS category 3 sonographic lesions. Of the 221 lesions, there were two confirmed cancers (0.9% malignancy rate). Koios DS assessed 112/221 lesions (50.7%) as benign, 42/221 lesions (19.0%) as probably benign, 64/221 lesions (29.0%) as suspicious, and 3/221 lesions (1.4%) as probably malignant. Koios DS had a sensitivity of 100% (2/2; 95% confidence interval [CI], 16% to 100%), specificity of 70% (154/219; 95% CI, 64% to 76%), negative predictive value of 100% (154/154; 95% CI, 98% to 100%), and false-positive rate of 30% (65/219; 95% CI, 24% to 36%).
Conclusion
When many follow-up appointments are delayed, e.g., natural disaster, or scenarios where resources are limited, breast ultrasound AI DS can help triage patients with probably benign breast ultrasounds.
6.Utilization of artificial intelligence to triage patients with delayed follow-up of probably benign breast ultrasound findings
Tali AMIR ; Kristen COFFEY ; Jeffrey S REINER ; Varadan SEVILIMEDU ; Victoria L MANGO
Ultrasonography 2025;44(2):145-152
Purpose:
This study aimed to evaluate our institution's experience in using artificial intelligence (AI) decision support (DS) as part of the clinical workflow to triage patients with Breast Imaging Reporting and Data System (BI-RADS) 3 sonographic lesions whose follow-up was delayed during the coronavirus disease 2019 (COVID-19) pandemic, against subsequent imaging and/or pathologic follow-up results.
Methods:
This retrospective study included patients with a BI-RADS category 3 (i.e., probably benign) breast ultrasound assessment from August 2019–December 2019 whose follow-up was delayed during the COVID-19 pandemic and whose breast ultrasounds were re-reviewed using Koios DS Breast AI as part of the clinical workflow for triaging these patients. The output of Koios DS was compared with the true outcome of a presence or absence of breast cancer defined by resolution/stability on imaging follow-up for at least 2 years or pathology results.
Results:
The study included 161 women (mean age, 52 years) with 221 BI-RADS category 3 sonographic lesions. Of the 221 lesions, there were two confirmed cancers (0.9% malignancy rate). Koios DS assessed 112/221 lesions (50.7%) as benign, 42/221 lesions (19.0%) as probably benign, 64/221 lesions (29.0%) as suspicious, and 3/221 lesions (1.4%) as probably malignant. Koios DS had a sensitivity of 100% (2/2; 95% confidence interval [CI], 16% to 100%), specificity of 70% (154/219; 95% CI, 64% to 76%), negative predictive value of 100% (154/154; 95% CI, 98% to 100%), and false-positive rate of 30% (65/219; 95% CI, 24% to 36%).
Conclusion
When many follow-up appointments are delayed, e.g., natural disaster, or scenarios where resources are limited, breast ultrasound AI DS can help triage patients with probably benign breast ultrasounds.

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