Efficacy of Crisaborole 2% Cream Versus Placebo in Mild to Moderate Atopic Eczema

Официальное название

Evaluation of the Efficacy of Crisaborole 2% Cream Compared to Placebo in the Management of Mild to Moderate Atopic Eczema

Обзор

This randomized controlled trial (RCT) aims to evaluate the efficacy and safety of Crisaborole 2% cream compared with placebo in patients with mild to moderate atopic dermatitis (AD), also known as atopic eczema. AD is a chronic inflammatory skin condition characterized by itching, redness, and recurrent flares that can significantly impair quality of life. Eligible participants aged 12 to 50 years with mild to moderate AD will be randomly assigned to receive either Crisaborole 2% cream or a placebo cream applied twice daily for four weeks. The primary outcome is treatment success at Day 28, defined using the Investigator's Static Global Assessment (ISGA) as a score of 0 (clear) or 1 (almost clear) with at least a two-grade improvement from baseline. Participants will be evaluated at baseline, Day 14, and Day 28. Safety, tolerability, and compliance will also be assessed. The results of this RCT may provide locally relevant evidence to guide the management of mild to moderate AD.

Подробное описание

Atopic dermatitis (AD), commonly referred to as atopic eczema, is a chronic, relapsing inflammatory skin disorder characterized by pruritus, erythema, and impaired skin barrier function. AD affects both children and adults and is associated with significant psychosocial burden, sleep disturbance, and reduced quality of life. Standard treatment options include topical corticosteroids and calcineurin inhibitors; however, prolonged use of these agents may be associated with adverse effects such as skin atrophy, irritation, and tachyphylaxis, highlighting the need for effective non-steroidal alternatives.

Crisaborole 2% cream is a topical phosphodiesterase-4 (PDE4) inhibitor that reduces inflammation by inhibiting cyclic adenosine monophosphate degradation and decreasing pro-inflammatory cytokine production. International clinical trials have demonstrated its efficacy in mild to moderate AD, but limited data are available from South Asian populations.

This study is a single-center, randomized, placebo-controlled trial conducted at the Department of Dermatology, Jinnah Postgraduate Medical Centre, Karachi. Participants aged 12 to 50 years with clinically diagnosed mild to moderate AD, defined by an ISGA score of 2 (mild) or 3 (moderate), will be enrolled after obtaining written informed consent.

Participants will be randomized in a 1:1 ratio into two groups:

Group A: Crisaborole 2% cream applied twice daily

Group B: Placebo cream applied twice daily

The treatment duration will be four weeks. Clinical assessments will be conducted at baseline, Day 14, and Day 28. The primary endpoint is treatment success at Day 28, defined as achieving an ISGA score of 0 or 1 with at least a two-grade improvement from baseline.

Secondary evaluations will include safety assessment, monitoring of adverse events, and treatment adherence. Comparative analysis will determine whether Crisaborole 2% cream provides superior efficacy compared with placebo in managing mild to moderate AD.

Вмешательства

• Препарат Placebo Cream
  Non-medicated topical cream identical in appearance and packaging to Crisaborole 2% cream, applied twice daily for four weeks.
• Препарат Crisaborole 2% Cream
  Crisaborole 2% Cream

Первичные конечные точки

• Proportion of Participants Achieving Treatment Success Based on Investigator's Static Global Assessment (ISGA) [Срок оценки: Day 28 (End of Treatment)]

Критерии участия

Критерии включения

• Age 12 to 50 years
• Clinically diagnosed mild to moderate atopic dermatitis (ISGA score 2 or 3)
• Willing and able to apply topical medication twice daily for four weeks
• Able to provide written informed consent (parental consent for participants under 18 years)

Критерии исключения

• Severe atopic dermatitis (ISGA score 4)
• Use of systemic corticosteroids, immunosuppressants, or antibiotics within the past two weeks
• Known hypersensitivity to crisaborole or any component of the formulation
• Pregnant or lactating women
• Presence of other significant dermatological conditions that may interfere with evaluation (e.g., psoriasis, scabies)
• Immunocompromised status (e.g., HIV infection, organ transplant recipient)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

• 8. Fowler JF, Hebert AA, Del Rosso JQ. Patient-reported outcomes of crisaborole treatment in real-world settings. Clin Cosmet Investig Dermatol. 2021;14:1443-1452.
• 7. Paller AS, Tom WL, Eichenfield LF. Efficacy of crisaborole ointment in pediatric patients with mild-to-moderate atopic dermatitis. JAMA Dermatol. 2020;156(5):556-563
• 6. Eichenfield LF, Tom WL, Chamlin SL. Evaluation of the safety and efficacy of crisaborole ointment for the treatment of atopic dermatitis in children and adolescents: results from two phase 3 studies. J Am Acad Dermatol. 2021;85(4):892-900.
• 5. Kaul S, Blauvelt A. Crisaborole: a nonsteroidal topical treatment for atopic dermatitis. Dermatol Ther. 2020;10(1):15-22.
• 4. Blauvelt A, Simpson EL, Tyring SK, et al. Long-term management of atopic dermatitis: perspectives on current and emerging topical treatments. J Am Acad Dermatol. 2023;88(4):1001-1010.
• 3. Kim JP, Chao LX, Simpson EL. Psychosocial burden of atopic dermatitis: A systematic review. Clin Dermatol. 2022;40(6):452-459
• 2. Mahmood K, Akhtar F, Hussain M. Pattern and frequency of atopic dermatitis in Pakistani children: a multicenter cross-sectional study. Pak J Med Sci. 2021;37(3):891-895
• 1. Odhiambo JA, Asher MI, Williams HC. Global variations in prevalence and severity of eczema symptoms in children. Int J Dermatol. 2020;59(5):582-589

Идентификаторы

NCT: NCT07438509 · JPMC-CRISA-2026-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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