Efficacy and Safety of TC Cream In Treating Patients With Psoriasis Vulgaris
Status: | Recruiting |
---|---|
Conditions: | Psoriasis |
Therapuetic Areas: | Dermatology / Plastic Surgery |
Healthy: | No |
Age Range: | 18 - 70 |
Updated: | 4/17/2018 |
Start Date: | June 11, 2015 |
End Date: | December 30, 2018 |
Contact: | Jiang Yang, Ph.D. |
Email: | terence0731@gmail.com |
Phone: | +1 6087721251 |
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.
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
Clinical Trial to Evaluate the Efficacy and Safety of TC cream In Treating Patients with
Psoriasis Vulgaris
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.
We found this trial at
2
sites
450 Clarkson Avenue
New York, New York 11203
New York, New York 11203
Principal Investigator: Edward Heilman, MD
Phone: 618-270-1229
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Seattle, Washington 98101
Principal Investigator: Peter J Jenkin, MD
Phone: 206-267-2100
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