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Trial record 17 of 92 for:    cream | "Psoriasis"

Study of Icotinib Hydrochloride Cream in Patients With Mild to Moderate Psoriasis

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ClinicalTrials.gov Identifier: NCT03222622
Recruitment Status : Terminated (The efficacy failed to meet the primary efficacy endpoint)
First Posted : July 19, 2017
Last Update Posted : November 14, 2018
Sponsor:
Collaborator:
Tigermed Consulting Co., Ltd
Information provided by (Responsible Party):
Betta Pharmaceuticals Co.,Ltd.

Brief Summary:
This is a phase II study to evaluate the efficacy and safety of Icotinib Hydrochloride Cream in patients with mild to moderate psoriasis.

Condition or disease Intervention/treatment Phase
Mild to Moderate Psoriasis Drug: Icotinib hydrochloride cream Drug: Placebo cream Phase 2

Detailed Description:
Icotinib Hydrochloride is an oral, small-molecule epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor, which has been approved for treating advanced non-small cell lung cancer (NSCLC) in China. Over-expressions of EGFR and its downstream signaling proteins are implicated in the pathogenesis of psoriasis and TKIs have been considered as potential antipsoriatic agents. Icotinib hydrochloride is being developed as a cream for the treatment of mild to moderate psoriasis. This is a multicenter , randomized, doubleblind, four-arm parallel-group, placebo-controlled phase II study to assess the efficacy and safety of icotinib hydrochloride cream (1.0%, 2.0%, 4.0%) in patients with mild to moderate psoriasis. Approximately 260 subjects will be enrolled.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 136 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Double-blind, Four-Arm Parallel-Group, Placebo-Controlled Phase II Study to Evaluate the Efficacy and Safety of Icotinib Hydrochloride Cream in Patients With Mild to Moderate Psoriasis
Actual Study Start Date : November 29, 2017
Actual Primary Completion Date : August 15, 2018
Actual Study Completion Date : October 26, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Arm Intervention/treatment
Experimental: Cohort 1
65 patients with mild to moderate psoriasis will be randomized to receive 1% Icotinib hydrochloride cream, applied twice daily for 12 consecutive weeks. The drug will be applied topically to the psoriasis site.
Drug: Icotinib hydrochloride cream
Apply topically twice daily for 12 consecutive weeks
Other Name: no other name

Experimental: Cohort 2
65 patients with mild to moderate psoriasis will be randomized to receive 2% Icotinib hydrochloride cream, applied twice daily for 12 consecutive weeks. The drug will be applied topically to the psoriasis site.
Drug: Icotinib hydrochloride cream
Apply topically twice daily for 12 consecutive weeks
Other Name: no other name

Experimental: Cohort 3
65 patients with mild to moderate psoriasis will be randomized to receive 4% Icotinib hydrochloride cream, applied twice daily for 12 consecutive weeks. The drug will be applied topically to the psoriasis site.
Drug: Icotinib hydrochloride cream
Apply topically twice daily for 12 consecutive weeks
Other Name: no other name

Placebo Comparator: Cohort 4
65 patients with mild to moderate psoriasis will be randomized to receive placebo cream (blank cream containing no icotinib hydrochloride), applied twice daily for 12 consecutive weeks. The drug will be applied topically to the psoriasis site.
Drug: Placebo cream
Apply topically twice daily for 12 consecutive weeks
Other Name: no other name




Primary Outcome Measures :
  1. Percentage of participants achieving a 50% improvement from baseline in psoriasis area and severity index (PASI 50) score at week 8 [ Time Frame: 8 weeks ]
    PASI: Combined assessment of lesion area and severity affected into single score. The body was divided into four sections [head (10% of a person's total skin); arms (20%); trunk (30%); legs (40%)]. For each section, the area of skin involved was scored from 0 (0%) to 6 (90-100%), and the severity of skin involved was estimated by clinical signs (erythema, induration, and desquamation) to score from 0 (none) to 4 (maximum). Final PASI = Sum of severity score for each section * area score * weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4). PASI 50 represents the percentage (or number) of patients who have achieved a 50% or more reduction in their PASI score from baseline.


Secondary Outcome Measures :
  1. PASI 50 score at each visit through week 12 (except week 8) [ Time Frame: Baseline to week 12 (except week 8) ]
    PASI: Combined assessment of lesion area and severity affected into single score. The body was divided into four sections [head (10% of a person's total skin); arms (20%); trunk (30%); legs (40%)]. For each section, the area of skin involved was scored from 0 (0%) to 6 (90-100%), and the severity of skin involved was estimated by clinical signs (erythema, induration, and desquamation) to score from 0 (none) to 4 (maximum). Final PASI = Sum of severity score for each section * area score * weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4). PASI 50 represents the percentage (or number) of patients who have achieved a 50% or more reduction in their PASI score from baseline.

  2. Percentage of participants achieving a 75% improvement from baseline in psoriasis area and severity index (PASI 75) score at each visit through week 12 [ Time Frame: Baseline to week 12 ]
    PASI: Combined assessment of lesion area and severity affected into single score. The body was divided into four sections [head (10% of a person's total skin); arms (20%); trunk (30%); legs (40%)]. For each section, the area of skin involved was scored from 0 (0%) to 6 (90-100%), and the severity of skin involved was estimated by clinical signs (erythema, induration, and desquamation) to score from 0 (none) to 4 (maximum). Final PASI = Sum of severity score for each section * area score * weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4). PASI 75 represents the percentage (or number) of patients who have achieved a 75% or more reduction in their PASI score from baseline.

  3. Change PASI score at each visit from baseline through week 12 [ Time Frame: Baseline to week 12 ]
    PASI: Combined assessment of lesion area and severity affected into single score. The body was divided into four sections [head (10% of a person's total skin); arms (20%); trunk (30%); legs (40%)]. For each section, the area of skin involved was scored from 0 (0%) to 6 (90-100%), and the severity of skin involved was estimated by clinical signs (erythema, induration, and desquamation) to score from 0 (none) to 4 (maximum). Final PASI = Sum of severity score for each section * area score * weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4).

  4. Percentage of participants achieving the physician global assessment (PGA) of psoriasis responses of clear (0) or almost clear (1) and ≥2 grade improvement at each visit through week 12 [ Time Frame: Baseline to week 12 ]
    PGA of Psoriasis: score based on dermatologist's assessment of skin disease averaged over all lesions. Overall lesions were graded for induration, erythema, and scaling; range: 0 (no evidence) to 5 (severe). Higher scores indicate greater severity of disease.

  5. Lesion severity [ Time Frame: Baseline to week 12 ]
    Lesion severity includes the sum of 3 indications, e.g. Erythema, scaling, thickness of target psoriasis site on patients with mild to moderate psoriasis. Each indication is scored from 0 (not at all serious) to 4 (very serious).


Other Outcome Measures:
  1. Safety in patients with mild to moderate psoriasis: Incidence and severity of Adverse Events, Physical Examinations, Vital signs, clinical laboratory assessments, ECG [ Time Frame: Baseline to week 12 ]
    Incidence and severity of Adverse Events, Physical Examinations, Vital signs (temperature, Heart Rate, blood pressure and respiration rate), clinical laboratory assessments (serum chemistry, hematology, C-reactive protein, fecal and urinalysis), ECG, etc.

  2. Dermatology Life Quality Index (DLQI) [ Time Frame: Baseline to week 12 ]
    DLQI assessment includes 10 items, which encompass aspects such as symptoms and feelings, daily activities, leisure, work or school, personal relationships and side-effects of the treatment. Each item is scored from 0 (not at all relevant) to 1 (a little relevant), 2 (a lot relevant) and 3 (very much relevant). The scores of items 1-10 for change from baseline are summarized here.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clinical diagnosed plaque psoriasis for at least six months with multiple treatable areas (i.e. the lesion should not only on the face, scalp, genitals or skinfolds) which covers less than 10% of the total Body Surface Area (BSA), and affected area on the limb and/or trunk ≥ 1% BSA. The long diameter and thickness of target plaque psoriasis was ≥ 2cm and ≥2, respectively.
  • In good health condition, with no history of diseases of major organs and no abnormality found on physical examination and vital signs.
  • Men and women of childbearing potential must agree to use a contraceptive regimen agreed by the doctor during the trial. Female subjects that are on hormonal contraceptives must continue using the same hormonal contraceptive as that was used in the past 3 months, with the same route of administration and the same dose during the whole study.
  • Have signed a written informed consent before entering the study.

Exclusion Criteria:

  • Psoriasis guttata, psoriasis punctata, erythrodermic psoriasis, pustular psoriasis, psoriasis arthritis.
  • Evidence of skin conditions other than psoriasis that would interfere with evaluations of the effect of study medication on psoriasis.
  • Drug-induced psoriasis.
  • Present with or had historical interstitial lung disease.
  • In the opinion of the investigator, the subjects were not considered appropriate candidates.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03222622


Locations
China, Zhejiang
The Second Affiliated hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310009
Sponsors and Collaborators
Betta Pharmaceuticals Co.,Ltd.
Tigermed Consulting Co., Ltd
Investigators
Principal Investigator: Min Zheng, PHD Second Affiliated Hospital, School of Medicine, Zhejiang University

Responsible Party: Betta Pharmaceuticals Co.,Ltd.
ClinicalTrials.gov Identifier: NCT03222622     History of Changes
Other Study ID Numbers: BTP-16322
First Posted: July 19, 2017    Key Record Dates
Last Update Posted: November 14, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Betta Pharmaceuticals Co.,Ltd.:
EGFR inhibitor, topical agent, psoriasis, phase 2

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases