Topical Diacerein in Psoriasis Vulgaris

NCT07352306 | Not Yet Recruiting Phase 4 DMC

• 1 other identifier: CP 3.2.1
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Psoriasis Vulgaris

Keywords

Diacerein; Psoriasis vulgaris; Topical; Interleukin-1β inhibitor; Randomized controlled trial

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• Proportion of Participants Achieving IGA/Body-IGA Success

  Week 8

• Proportion of Participants Achieving PASI 90

  Week 8

• Proportion of Participants Achieving DLQI ≤5

  Week 8

Study Arms (2)

Topical Diacerein

EXPERIMENTAL

Participants assigned to this arm will receive topical diacerein cream 1% applied twice daily for a treatment period of two months.

Drug: Diacerein

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.

Drug: Placebo

Interventions

Diacerein DRUG

Topical diacerein cream 1% will be applied to affected skin areas twice daily for a treatment duration of two months.

Also known as: Topical diacerein

Topical Diacerein

Placebo DRUG

A matching placebo topical formulation will be applied to affected skin areas twice daily for a treatment duration of two months.

Also known as: Matching placebo topical formulation

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Kasr Al-Ainy Psoriasis Unit

Cairo, Egypt

Location

Related Publications (11)

• 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 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.

  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.

  PMID: 36125472 BACKGROUND

• World Medical Association. World Medical Association Declaration of Helsinki: Ethical Principles for Medical Research Involving Human Participants. JAMA. 2025 Jan 7;333(1):71-74. doi: 10.1001/jama.2024.21972.

  PMID: 39425955 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.

  PMID: 29410318 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.

  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.

  PMID: 34975883 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.

  PMID: 40563994 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.

  PMID: 37235479 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.

  PMID: 36901755 BACKGROUND

MeSH Terms

Interventions

diacerein

Central Study Contacts

Alaa A Helal, BSc in Pharmacy

CONTACT

1124438381; alaa.ashraf.muhammad@std.pharma.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Teaching Assistant, Clinical Pharmacy Department, Faculty of Pharmacy, Ahram Canadian University

Model Details: 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.

Study Record Dates

• First Submitted: January 11, 2026
• First Posted: January 20, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: January 20, 2026

Record last verified: 2026-01

Locations

EG (1)