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A phase III, multicenter, randomized, blind, controlled trial for efficacy and safety of tazarotene and betamethasone dipropionate cream in the treatment of subjects with psoriasis vulgaris

A phase III, multicenter, randomized, blind, controlled trial for efficacy and safety of tazarotene and betamethasone dipropionate cream in the treatment of subjects with psoriasis vulgaris

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900024450
Enrollment
Unknown
Registered
2019-07-12
Start date
2010-03-15
Completion date
Unknown
Last updated
2019-07-15

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

Conditions

Psoriasis vulgaris

Interventions

Group 1:0.05% betamethasone dipropionate cream (Applied twice daily in the morning and evening)
Group 2:Placebo(once in the morning) +0.05% tazarotene gel (once in the evening)
Group 3:Placebo (once in the morning) + Tazarotene and Betamethasone Dipropionate Cream (once in the evening)

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) Diagnosis of chronic plaque psoriasis; (2) Psoriasis affecting <20% of the body surface area; (3) Aged between 18 and 65 years, either sex; (4) Subjects having understood and signed a written informed consent form prior to any study related procedures being carried out.

Exclusion criteria

Exclusion criteria: (1) Treatment with tretinoin drugs within 16 weeks, anti-tumor drugs within 6 weeks, topical or phototherapy within 4 weeks prior to randomization; (2) History of allergy to tretinoin drugs or any component of the study drug; (3) Patients with systemic diseases such as endocrine diseases, mental diseases, blood diseases, liver and kidney diseases, cardiovascular and cerebrovascular diseases, and immune dysfunction; (4) Females who are pregnant, wishing to become pregnant in the next 3 months, or are breast-feeding. (5) Psoriasis affecting more than 20% of body surface area; (6) Diagnosis of psoriasis other than the type of chronic plaque psoriasis; (7) Treatment with systemic anti-psoriasis medications during the study period; (8) Participation in any other clinical study 3 months prior to randomization; (9) Patients excluded by the investigator; (10) Planned initiation of, or changes in, concomitant medication that may affect the observation and judgment of the study; (11) Staff members directly involved in the study.

Design outcomes

Primary

MeasureTime frame
Decline rate of PASI;

Secondary

MeasureTime frame
Target lesion recurrence rate;

Countries

China

Contacts

Public ContactSun Jianfang

Chinese Academy of Medical Sciences & Hospital for Skin Diseases

Fangmin5758@yahoo.com.cn+86 13951984310

Outcome results

None listed

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