Steroid-reducing Effects of Crisaborole
Anahtar kelimeler
Öz
Açıklama
Atopic dermatitis (AD) is a chronic skin disease and a common affliction among children. Twice daily topical corticosteroid (TCS) use over several weeks is recommended for active inflammatory disease. Side effects of TCS range from cutaneous atrophy to hypothalamic-pituitary-adrenal axis suppression. Steroid phobia and misunderstanding often lead to poor compliance and inadequate disease control. Topical calcineurin inhibitors (TCIs) are currently recommended as steroid-reducing agents, especially on sensitive areas such as the face and skin folds. However, TCis are associated with burning reactions and come with black box warnings.
Crisaborole (Eucrisa), the newest topical prescription option for AD, is a phosphodiesterase-4 inhibitor with demonstrated efficacy in patients aged 2 and older with mild to moderate AD. Given the good tolerability and favorable safety profile, crisaborole makes for an alternative topical option to its predecessors. However, corresponding data are lacking. It would be of great interest to patients, patients' families and providers if crisaborole can be shown to reduce the amount of TCS necessary for control of AD. The investigators therefore propose a proof-of-concept study to investigate whether crisaborole can serve as an effective steroid-reducing agent.
Tarih
| Son Doğrulandı: | 12/31/2019 |
| İlk Gönderilen: | 01/24/2019 |
| Tahmini Kayıt Gönderildi: | 02/03/2019 |
| İlk Gönderilen: | 02/05/2019 |
| Son Güncelleme Gönderildi: | 01/12/2020 |
| Son Güncelleme Gönderildi: | 01/13/2020 |
| Fiili Çalışma Başlangıç Tarihi: | 12/16/2019 |
| Tahmini Birincil Tamamlanma Tarihi: | 10/31/2020 |
| Tahmini Çalışma Tamamlanma Tarihi: | 10/31/2020 |
Durum veya hastalık
Müdahale / tedavi
Drug: Crisaborole
Drug: Hydrocortisone Ointment
Drug: Triamcinolone ointment
Drug: Aquaphor
Evre
Kol Grupları
| Kol | Müdahale / tedavi |
|---|---|
| Active Comparator: Crisaborole Participants will be instructed to apply emollient, topical steroid, and or crisaborole (blinded) to affected areas with eczema. | Drug: Crisaborole Participants will be instructed to apply crisaborole to affected areas with eczema. |
| Placebo Comparator: Vehicle Participants will be instructed to apply emollient, topical steroid, and or vehicle (blinded) to affected areas with eczema. | |
| Sham Comparator: Control Participants will be instructed to apply emollient, topical steroid, and or emollient (blinded) to affected areas with eczema. |
Uygunluk kriterleri
| Çalışmaya Uygun Yaşlar | 2 Years İçin 2 Years |
| Çalışmaya Uygun Cinsiyetler | All |
| Sağlıklı Gönüllüleri Kabul Ediyor | Evet |
| Kriterler | Inclusion criteria: - Children aged 2 or older (<18). - Diagnosed with atopic dermatitis. - At baseline, AD is mild to moderate (score of 2 [mild] to 3 [moderate]) on the Investigator's Global Assessment scale (IGA; scores range 0-4, higher indicates greater severity). Exclusion criteria: - Known allergy to a constituent of the studied products (crisaborole, vehicle, Aquaphor, topical steroids [hydrocortisone 2.5% ointment and triamcinolone acetonide 0.1% ointment]). - At baseline, AD is severe (score of 4 [severe] on the IGA scale). - Medical problems which interfere with completion of protocols in this study. - Pregnant or lactating females. (Females who have experienced menarche will be required to take a urine pregnancy test.) - Participant is enrolled in another research study. - Participant or participant's guardian(s) are unable to follow instructions as required in this study. |
Sonuç
Birincil Sonuç Ölçütleri
1. Steroid usage quantity [Day 30]
2. Steroid usage quantity [Day 90]
3. Steroid usage frequency [Day 30]
4. Steroid usage frequency [Day 90]
5. Steroid refills [Day 30]
6. Steroid refills [Day 90]
İkincil Sonuç Ölçütleri
1. Eczema severity as assessed by SCORing Atopic Dermatitis (SCORAD) score [Day 0]
2. Eczema severity assessed by SCORAD score [Day 30]
3. Eczema severity assessed by SCORAD score [Day 90]
4. Quality of life for participant as assessed by Children's Dermatology Life Quality Index [Day 0]
5. Quality of life for participant as assessed by Dermatology Life Quality Index [Day 0]
6. Quality of life for participant as assessed by Children's Dermatology Life Quality Index [Day 30]
7. Quality of life for participant as assessed by Dermatology Life Quality Index [Day 30]
8. Quality of life for participant as assessed by Children's Dermatology Life Quality Index [Day 90]
9. Quality of life for participant as assessed by Dermatology Life Quality Index [Day 90]
10. Quality of life for family as assessed by Dermatitis Family Impact Questionnaire [Day 0]
11. Quality of life for family as assessed by Dermatitis Family Impact Questionnaire [Day 30]
12. Quality of life for family as assessed by Dermatitis Family Impact Questionnaire [Day 90]
13. Severity of itching as assessed by Pruritus score [Day 0]
14. Severity of itching as assessed by Pruritus score [Day 30]
15. Severity of itching as assessed by Pruritus score [Day 90]
