The efficacy and safety of amino acids replacement based on metabolomics in generalized pustular psoriasis: a prospective, randomized, double-blind, controlled study

Status

Recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2000037099

Enrollment

Unknown

Registered

2020-08-26

Start date

2020-10-01

Completion date

Unknown

Last updated

2020-10-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Generalized pustular psoriasis

Interventions

experimental group:amino acid infusion plus oral acitretin

control group:oral acitretin

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients with a gppga score of 0 or 1, a known and documented history of GPP that meets the criteria of the European expert network of rare and severe psoriasis (eraspen), and / or previous evidence of fever and / or fatigue, and / or myalgia, and / or elevated C-reactive protein and / or leukocytosis with peripheral neutropenia (higher than ULN). 2. Male or female patients aged between 18 and 70 at the time of screening. 3. Before starting any screening procedure, the patient must have signed and dated the written informed consent before entering the study. 4. Fertile women must take effective contraceptive measures.

Exclusion criteria

Exclusion criteria: 1. Patients with SAPHO syndrome. 2. Patients with primary erythroderma psoriasis vulgaris. 3. Patients with primary plaque psoriasis vulgaris, without pustules or pustules limited to psoriatic plaques. 4. Patients with drug-induced acute generalized exanthematous pustulosis (AGEP). 5. According to the judgment of the researchers, the patients who have an immediate life-threatening GPP attack or need intensive care treatment. Life threatening complications include, but are not limited to, cardiovascular / cytokine driven shock, respiratory distress syndrome or renal failure. 6. Patients with severe, progressive or uncontrolled liver disease were defined as elevated ast or ALT or alkaline phosphatase > 3 times upper limit of normal (ULN) or total bilirubin > 2 times ULN. 7. Moderate to severe hypertriglyceridemia was defined as elevated serum triglyceride level > 2.27mmol/l.

Design outcomes

Primary

Measure	Time frame
GPP severity score;	—

Secondary

Measure	Time frame
WBC count;CRP levels;metabolite levels;	—

Countries

China

Contacts

Public ContactNing Yu

Shanghai Dermatology Hospital

ning_yu@vip.163.com+86 18017336571

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026