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A Multicenter, Randomized, Open-Label Clinical Trial of Tazarotene and Betamethasone Dipropionate Cream Alone or Sequentially With Tazarotene Gel In the Treatment of Chronic Plaque Psoriasis

A Multicenter, Randomized, Open-Label Clinical Trial of Tazarotene and Betamethasone Dipropionate Cream Alone or Sequentially With Tazarotene Gel In the Treatment of Chronic Plaque Psoriasis

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900027060
Enrollment
Unknown
Registered
2019-10-30
Start date
2017-03-01
Completion date
Unknown
Last updated
2019-11-04

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

Conditions

Chronic Plaque Psoriasis

Interventions

Group A:Tazarotene and Betamethasone Dipropionate Cream (once daily)
Group B:Tazarotene and Betamethasone Dipropionate Cream (on weekends)
Tazarotene Gel (on workdays)

Sponsors

Chinese Academy of Medical Sciences & Hospital for Skin Diseases
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: (1) Patients clinically diagnosed with chronic plaque psoriasis; (2) Completed the treatment of Tazarotene and Betamethasone Dipropionate Cream for 4 weeks, and percentage reduction in PASI is between (50%, 90%); (3) Subjects who voluntarily signed the informed consent form of the study; (4) After 4 weeks treatment, no adverse events required to follow-up.

Exclusion criteria

Exclusion criteria: (1) Who are allergic to retinoids and/or any of the study medication ingredients; (2) Guttate, erythrodermic, pustular and arthritic psoriasis patients; Patients with severe skin damage and infection at the site of the lesion and other skin disease that may confound the evaluation of the plaque psoriasis; (3) Patients suffering from severe organ and systemic diseases, including cardiovascular (such as heart failure, unstable angina), liver (such as cirrhosis), kidney (such as renal failure), lung (such as chronic obstructive pulmonary disease), endocrine (such as Cushing syndrome), nervous system and blood system diseases, and other autoimmune diseases, malignant tumors or other diseases that are not suitable for this study inn the investigators opinion; (4) The following abnormalities occurred in the laboratory test results during screening: peripheral blood white blood cell count is less than 3.0x10^9/ L, or greater than 15 x 10^9 /L; hemoglobin is less than 90g/L; platelets less than 100 x 10^9 / L; ALT and AST are more than twice the upper limit of the normal value; serum creatinine, BUN reached 1.5 times the upper limit of normal;triglycerides or total cholesterol reach more than 3 times the upper limit of normal; women of childbearing age who are positive for blood pregnancy test; (5) Pregnant woman; lactating woman; women who are planning a pregnancy during the study; (6) Conditions that may affect patients compliance, such as long-term business trips or vacations, drug abuse, drug addiction, and people with mental illness; (7) Other unsuitable subjects in the investigators opinion.

Design outcomes

Primary

MeasureTime frame
Percentage reduction in PASI from baseline(-4 week) after 4 weeks of treatment.;

Secondary

MeasureTime frame
Proportion of subjects achieving PASI 50, 75, and 90 from baseline(-4 week);Percentage reduction in PASI from baseline(-4 week) after 2 weeks of treatment.;Proportion of “ treatment success” subjects by the physician’s global assessment (PGA) after 2 and 4 weeks of treatment from baseline(-4 week);Dermatology Life Quality Index (DLQI);Incidence of Adverse drug reaction;Incidence of adverse drug reactions related to glucocorticoids;

Countries

China

Contacts

Public ContactSun Jianfang

Chinese Academy of Medical Sciences & Hospital for Skin Diseases

fangmin5758@aliyun.com+86 13951984310

Outcome results

None listed

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