Efficacy and Safety of TC Cream In Treating Patients With Psoriasis Vulgaris

Psoriasis Research Institute of Guangzhou

Status and phase

Completed

Phase 2

Conditions

Psoriasis Vulgaris

Treatments

Drug: TC cream

Drug: Vehicle

Study type

Interventional

Funder types

Industry

Identifiers

NCT03372811

105883-1

Details and patient eligibility

About

A Double-Blind, Randomized, Placebo-Controlled, Parallel-Controlled, Two-Center, Phase IIb Clinical Trial to Evaluate the Efficacy and Safety of TC cream In Treating Patients with Psoriasis Vulgaris

Enrollment

88 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Age of 18-70 years old. Both men and women and members of all races and ethnic groups
Consistent with diagnostic criteria of stable phase psoriasis vulgaris and have at least two target lesions suitable for evaluation
Women of childbearing age must be using birth control strategies defined by one of the following: 1) a barrier method (condom) and/or 2) oral contraceptives, during the 8-week study period.
ISGA score ≥ 2 (at least mild severity)
BSA (stable stage group): 1%≤ to ≤20%
Signed a written informed consent document
No additional exposure to the sun

Exclusion criteria

Subjects in pregnancy, preparing for pregnancy or breast feeding
History of hyperergic or photosensitivity
History of complicated cardiovascular diseases, cerebrovascular diseases, severe primary diseases of hepatic, kidney and hematopoietic system, or patients with psychiatric disorders
History of photosensitive diseases such as porphyria, chronic actinic dermatitis, Xeroderma pigmentosa
Within 4 weeks prior to randomizations, patients have taken treatment with following approved or investigational psoriasis therapies on the target lesions:
- Topical treatments
- PUVA, UVB or Grenz ray therapy.
- Any systemic treatments other than biologicals with a possible effect on psoriasis (e.g., corticosteroids, vitamin D analogues, hydroxycarbamide, azathioprine, methotrexate, cyclosporine, other immunosuppressant).
- Any types of other investigational therapies for psoriasis
Within 3 months prior to randomizations, patients have taken systemic treatments with retinoids or biological therapies (marketed or otherwise) with a possible effect on psoriasis (e.g., alefacept, efalizumab, etanercept, infliximab).
Planned initiation of, or changes to, concomitant medications that could affect psoriasis (e.g., beta blockers, anti-malaria drugs, lithium) during the double-blind phase of the study.
History of allergic reactions attributed to compounds of similar chemical or biologic compositions to Coumarins.