Topical Diacerein in Psoriasis Vulgaris

Официальное название

The Efficacy of Topical Diacerein Cream in Patients With Psoriasis Vulgaris

Обзор

The goal of this clinical trial is to evaluate the safety and effectiveness of topical diacerein in adults with psoriasis vulgaris. The primary objective of the study is to compare the proportion of participants who achieve a clinically meaningful improvement in disease severity between the topical diacerein group and the placebo group. Participants will: Be assigned to receive topical diacerein 1% or placebo twice daily for a treatment period of 2 months. Attend follow-up visits at Weeks 2, 4, 6, and 8. Undergo an additional evaluation one month after treatment cessation.

Подробное описание

This is a phase IV, randomized, placebo-controlled, double-blind clinical study designed to evaluate the efficacy and safety of topical diacerein in adults with psoriasis vulgaris. Participants who meet eligibility criteria will be randomized to receive either topical diacerein or matching placebo. The study treatment will be applied twice daily for two months. Participants will attend follow-up visits at Weeks 2, 4, 6, and 8, during which clinical evaluations, safety assessments, and efficacy measurements will be conducted.

The primary efficacy endpoint is the proportion of participants achieving at least a 75% improvement from baseline in the Psoriasis Area and Severity Index (PASI 75) at Week 8. Secondary endpoints may include additional PASI response thresholds, investigator global assessments, patient-reported outcomes, and safety endpoints. Safety will be monitored throughout the study through the collection of adverse events, physical examinations, and other relevant clinical assessments.

Вмешательства

• Препарат Diacerein
  Topical diacerein cream 1% will be applied to affected skin areas twice daily for a treatment duration of two months.
• Препарат Placebo
  A matching placebo topical formulation will be applied to affected skin areas twice daily for a treatment duration of two months.

Первичные конечные точки

• Proportion of Participants Achieving PASI 75 [Срок оценки: Week 8]

Вторичные конечные точки (3)

• Proportion of Participants Achieving IGA/Body-IGA Success [Срок оценки: Week 8]
• Proportion of Participants Achieving PASI 90 [Срок оценки: Week 8]
• Proportion of Participants Achieving DLQI ≤5 [Срок оценки: Week 8]

Критерии участия

Критерии включения

• Age ≥18 years old of both genders.
• Patients with mild chronic plaque psoriasis body surface area (BSA < 10%) along with Psoriasis Area and Severity Index (PASI) score of < 10, and/or Dermatology Life Quality Index (DLQI) score of <10.

Критерии исключения

• Documented hypersensitivity or idiosyncratic reaction to the investigational product or any excipients contained within the cream formulation.
• Intake of anti-psoriatic systemic therapy within the last 3 months, or topical treatments within the last 2 weeks.
• Patients with pustular psoriasis.
• Pregnant and breast-feeding individuals.
• Patients with psoriatic arthritis.

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

Египет · 1 центр

• Kasr Al-Ainy Psoriasis Unit — Cairo

Публикации

• Armstrong AW, Lee K, Yee D, Woodbury M, Zundell M, Zagona-Prizio C, Yousif J, Grant C, Shields A, Chou P, Callis Duffin K, Gottlieb AB, Merola JF, Perez-Chada L. Validation of DermSat-7 for Assessing Treatment Satisfaction in Patients With Psoriasis. JAMA Dermatol. 2025 Feb 26;161(4):416-20. doi: 10.1001/jamadermatol.2024.6567. Online ahead of print. PMID 40009402
• Nael, S., M. Abbassi, and S. Farid, MSR225 Translation and Cultural Adaptation of Four EQ Bolt-Ons for the Use in the Quantitative Psychometric Investigation in Egyptian Patients With Chronic Skin Conditions. Value in Health, 2024. 27(12): p. S482.
• Napoli, G.D., Diacerein for use in treating psoriasis. 2003.
• Lebwohl MG, Kircik LH, Moore AY, Stein Gold L, Draelos ZD, Gooderham MJ, Papp KA, Bagel J, Bhatia N, Del Rosso JQ, Ferris LK, Green LJ, Hebert AA, Jones T, Kempers SE, Pariser DM, Yamauchi PS, Zirwas M, Albrecht L, Devani AR, Lomaga M, Feng A, Snyder S, Burnett P, Higham RC, Berk DR. Effect of Roflumilast Cream vs Vehicle Cream on Chronic Plaque Psoriasis: The DERMIS-1 and DERMIS-2 Randomized Clin PMID 36125472
• Association, W.M. Declaration of Helsinki: Ethical Principles for Medical Research Involving Human Participants. 2025 [cited 2025 August 3, 2025]; Available from: https://www.wma.net/policies-post/wma-declaration-of-helsinki/.
• Wally V, Hovnanian A, Ly J, Buckova H, Brunner V, Lettner T, Ablinger M, Felder TK, Hofbauer P, Wolkersdorfer M, Lagler FB, Hitzl W, Laimer M, Kitzmuller S, Diem A, Bauer JW. Diacerein orphan drug development for epidermolysis bullosa simplex: A phase 2/3 randomized, placebo-controlled, double-blind clinical trial. J Am Acad Dermatol. 2018 May;78(5):892-901.e7. doi: 10.1016/j.jaad.2018.01.019. Epu PMID 29410318
• Baxi, K., et al., Diacerein in the treatment of chronic plaque psoriasis: A case report. Indian Journal of Drugs in Dermatology, 2022. 8(2): p. 79-82.
• Hu P, Wang M, Gao H, Zheng A, Li J, Mu D, Tong J. The Role of Helper T Cells in Psoriasis. Front Immunol. 2021 Dec 15;12:788940. doi: 10.3389/fimmu.2021.788940. eCollection 2021. PMID 34975883

Идентификаторы

NCT: NCT07352306 · CP 3.2.1

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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