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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Topical Diacerein | Experimental | Participants assigned to this arm will receive topical diacerein cream 1% applied twice daily for a treatment period of two months. |
|
| Placebo | Placebo Comparator | Participants assigned to this arm will receive a matching placebo topical cream applied twice daily for a treatment period of two months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diacerein | Drug | Topical diacerein cream 1% will be applied to affected skin areas twice daily for a treatment duration of two months. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Participants Achieving PASI 75 | The proportion of participants who achieve at least a 75% improvement from baseline in the Psoriasis Area and Severity Index (PASI 75), comparing the topical diacerein group with the placebo group. | Week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Participants Achieving IGA/Body-IGA Success | The proportion of participants achieving Investigator's Global Assessment (IGA) or Body-IGA success, defined as a score of clear or almost clear with at least a 2-grade improvement from baseline | Week 8 |
| Proportion of Participants Achieving PASI 90 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alaa A Helal, BSc in Pharmacy | Contact | 1124438381 | +20 | alaa.ashraf.muhammad@std.pharma.cu.edu.eg |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kasr Al-Ainy Psoriasis Unit | Cairo | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40009402 | Background | 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. | |
| Background | 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. | ||
| Background | Napoli, G.D., Diacerein for use in treating psoriasis. 2003. | ||
| 36125472 |
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A decision regarding the sharing of individual participant data (IPD) has not yet been finalized. The availability of IPD will be determined at a later date based on ethical approvals, participant consent, data protection requirements, and institutional and sponsor policies.
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| ID | Term |
|---|---|
| C025292 | diacerein |
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This study is designed as a prospective, randomized, double-blind, parallel-arm, placebo-controlled clinical trial. Participants will be randomly assigned in a 1:1 ratio to receive either topical diacerein cream or a matching placebo cream. Participants will remain in their assigned treatment arm for the duration of the study, with outcomes assessed according to the prespecified schedule. No crossover between treatment arms is planned.
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Participants will be randomly assigned to study groups using a computer-generated allocation sequence. Allocation concealment will be ensured through the use of sequentially numbered, opaque, sealed envelopes prepared by an independent individual and opened only after eligibility confirmation and informed consent.
The investigational product and placebo will be identical in appearance and texture and prepared by qualified study personnel. Both participants and treating clinicians will remain blinded to treatment assignment for the duration of the study.
| Placebo | Drug | A matching placebo topical formulation will be applied to affected skin areas twice daily for a treatment duration of two months. |
|
|
The percentage of participants achieving at least a 90% improvement from baseline in the Psoriasis Area and Severity Index (PASI 90). |
| Week 8 |
| Proportion of Participants Achieving DLQI ≤5 | Percentage of participants with a Dermatology Life Quality Index (DLQI) total score of ≤5. | Week 8 |
| Background |
| 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 Clinical Trials. JAMA. 2022 Sep 20;328(11):1073-1084. doi: 10.1001/jama.2022.15632. |
| Background | 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/. |
| 29410318 | Background | 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. Epub 2018 Feb 2. |
| Background | 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. |
| 34975883 | Background | 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. |
| 40563994 | Background | Elkalla N, Elhamammsy MH, Bedair NI, Elazazy O, El Kholy AA. A Promising Approach to Psoriasis Vulgaris Management with N-Acetylcysteine and Vitamin E: Targeting the Interplay of Inflammatory and Oxidative Stress. Biomedicines. 2025 May 22;13(6):1275. doi: 10.3390/biomedicines13061275. |
| 37235479 | Background | Ramic L, Sator P. Topical treatment of psoriasis vulgaris. J Dtsch Dermatol Ges. 2023 Jun;21(6):631-642. doi: 10.1111/ddg.15042. Epub 2023 May 26. |
| 36901755 | Background | Brunner SM, Ramspacher A, Rieser C, Leitner J, Heil H, Ablinger M, Tevini J, Wimmer M, Koller A, Pinon Hofbauer J, Felder TK, Bauer JW, Kofler B, Lang R, Wally V. Topical Diacerein Decreases Skin and Splenic CD11c+ Dendritic Cells in Psoriasis. Int J Mol Sci. 2023 Feb 21;24(5):4324. doi: 10.3390/ijms24054324. |