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

• Status: Completed
• Trial end date: 2018-06-30
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Psoriasis Research Institute of Guangzhou

Criteria

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.