AzTrials
AzTrials

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.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

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
Are there results?
Not yet: the study is under way

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.

Alaa A Helal, BSc in Pharmacy contact

1124438381 ext. +20

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

Egypt1 site, 1 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

    Recruiting

Other trials in Egypt

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.

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 groups in NCT07352306
Study groupRoleWhat they receive
Topical DiacereinExperimentalParticipants assigned to this arm will receive topical diacerein cream 1% applied twice daily for a treatment period of two months.
Receives: Drug: Diacerein
PlaceboPlacebo comparatorParticipants 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.

  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.

    Measured: Week 8

Secondary outcomes (3)

  1. 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

  2. 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

  3. 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.

  1. First posted20 Jan 2026
  2. Study start11 Apr 2026
  3. Primary completion1 Feb 2027 (estimated)
  4. Study completion1 May 2027 (estimated)

Resources

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)
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 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 Clinical Trials. JAMA. 2022 Sep 20;328(11):1073-1084. doi: 10.1001/jama.2022.15632.

    PubMed 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. Epub 2018 Feb 2.

    PubMed 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.

    PubMed 34975883

  • 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.

    PubMed 40563994

  • 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.

    PubMed 37235479

  • 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.

    PubMed 36901755

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Diacerein in people with Psoriasis Vulgaris, run by Alaa Ashraf Muhammad Helal at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 22 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Alaa A Helal, BSc in Pharmacy (1124438381 ext. +20, alaa.ashraf.muhammad@std.pharma.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of Participants Achieving PASI 75 (time frame: Week 8). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07352306, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in