Psoriasis VulgarisPhase 4DIANCT07352306
Topical Diacerein in Psoriasis Vulgaris
A Phase 4 study testing Diacerein in people with Psoriasis Vulgaris, run by Alaa Ashraf Muhammad Helal at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psoriasis Vulgaris
- What is being tested?
- Diacerein
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 11 Apr 2026to 1 May 2027
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Kasr Al-Ainy Psoriasis Unit
Cairo
Yousra A Azzazi, PhD, Faculty of Medicine, 109 870 9984 ext. +20
Yousra A Azzazi, PhD, Faculty of Medicine
About this study
Official title: The Efficacy of Topical Diacerein Cream in Patients With Psoriasis Vulgaris
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.
Read the detailed description
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.
- Conditions
- Psoriasis Vulgaris
- Being tested
- Diacerein, Placebo
- Keywords
- Diacerein, Psoriasis vulgaris, Topical, Interleukin-1β inhibitor, Randomized controlled trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DiacereinDrug
Also called Topical diacerein
Topical diacerein cream 1% will be applied to affected skin areas twice daily for a treatment duration of two months.
PlaceboDrug
Also called Matching placebo topical formulation
A matching placebo topical formulation will be applied to affected skin areas twice daily for a treatment duration of two months.
| Study group | Role | What they receive |
|---|---|---|
| Topical Diacerein | Experimental | Participants assigned to this arm will receive topical diacerein cream 1% applied twice daily for a treatment period of two months. Receives: 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Week 8
Secondary outcomes (3)
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
Measured: Week 8
Proportion of Participants Achieving PASI 90
The percentage of participants achieving at least a 90% improvement from baseline in the Psoriasis Area and Severity Index (PASI 90).
Measured: Week 8
Proportion of Participants Achieving DLQI ≤5
Percentage of participants with a Dermatology Life Quality Index (DLQI) total score of ≤5.
Measured: Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2026
- Study start11 Apr 2026
- Primary completion1 Feb 2027 (estimated)
- Study completion1 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Psoriasis VulgarisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alaa Ashraf Muhammad Helal
- Sponsor type
- University, hospital or other
- Collaborators
- Cairo University
- Responsible party
- Sponsor-investigator, Alaa Ashraf Muhammad Helal, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07352306
- Sponsor's protocol ID
- CP 3.2.1
- Acronym
- DIA
- Status last verified
- Oct 2026
- First submitted
- 11 Jan 2026
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: 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.
Publications
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.
PubMed 40009402Nael, 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 Clinical Trials. JAMA. 2022 Sep 20;328(11):1073-1084. doi: 10.1001/jama.2022.15632.
PubMed 36125472Association, 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. Epub 2018 Feb 2.
PubMed 29410318Baxi, 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.
PubMed 34975883Elkalla 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.
PubMed 40563994Ramic 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.
PubMed 37235479Brunner 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.
PubMed 36901755