Trial | NCT03372811  Report issue

Title

Efficacy and Safety of TC Cream In Treating Patients With Psoriasis Vulgaris
A Double-Blind, Randomized, Placebo-Controlled, Parallel-Controlled, Two-Center, Phase 2b Clinical Trial to Evaluate the Efficacy and Safety of TC Cream In Treating Patients With Psoriasis Vulgaris.

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    88
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
Study Started
Jun 11
2015
Primary Completion
Mar 14
2018
Study Completion
Jun 30
2018
Last Update
May 16
2019

Drug TC cream [lidocaine (xylocaine), menthol (Salonpas)]

A well-characterized botanical drug for topical treatment of psoriasis vulgaris

Drug Vehicle

Vehicle

TC cream (10%) Active Comparator

Vehicle Placebo Comparator

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.
No Results Posted