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Icotinib Hydrochloride Cream in Patients With Mild to Moderate Psoriasis

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ClinicalTrials.gov Identifier: NCT02801435
Recruitment Status : Completed
First Posted : June 15, 2016
Last Update Posted : July 17, 2017
Sponsor:
Collaborator:
Tigermed Consulting Co., Ltd
Information provided by (Responsible Party):
Betta Pharmaceuticals Co., Ltd.

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

Condition or disease Intervention/treatment Phase
Psoriasis Drug: 0.5% Icotinib hydrochloride cream Drug: 1.0% Icotinib hydrochloride cream Drug: 2.0% Icotinib hydrochloride cream Drug: 4.0% Icotinib hydrochloride cream Drug: Placebo Phase 1

Detailed Description:
Icotinib Hydrochloride is a small-molecule epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor, which has been approved for the treatment of advanced nonsmall- cell lung cancer (NSCLC) in China in its oral form. As EGFR is implicated in the pathogenesis of psoriasis, icotinib hydrochloride is being developed as a cream for the treatment of mild to moderate psoriasis. This is a single-center, randomized, doubleblind, placebo-controlled study of 0.5%, 1.0%, 2.0%, 4.0% icotinib hydrochloride cream by topical administration. Icotinib hydrochloride cream will be applied to subjects with mild to moderate psoriasis. Approximately 40 subjects will be enrolled.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 41 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Single-Center, Randomized, Double-blind, Placebo-Controlled Study to Evaluate Safety, Tolerability and Pharmacokinetics of Icotinib Hydrochloride Cream in Patients With Mild to Moderate Psoriasis
Actual Study Start Date : September 17, 2016
Actual Primary Completion Date : June 8, 2017
Actual Study Completion Date : June 8, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Arm Intervention/treatment
Experimental: Cohort 1-Experimental
8 patients with mild to moderate psoriasis will be randomized to receive 0.5% Icotinib hydrochloride cream, applied twice daily for 4 consecutive weeks. The drug will be applied topically to the psoriasis site.
Drug: 0.5% Icotinib hydrochloride cream
Topical administration for twice daily
Other Name: no other name

Placebo Comparator: Cohort 1-Placebo
2 patients with mild to moderate psoriasis will be randomized to receive matching placebo, applied twice daily for 4 consecutive weeks. The drug will be applied topically to the psoriasis site.
Drug: Placebo
Topical administration for twice daily
Other Name: Blank cream

Experimental: Cohort 2-Experimental
8 patients with mild to moderate psoriasis will be randomized to receive 1.0% Icotinib hydrochloride cream, applied twice daily for 4 consecutive weeks. The drug will be applied topically to the psoriasis site.
Drug: 1.0% Icotinib hydrochloride cream
Topical administration for twice daily
Other Name: no other name

Placebo Comparator: Cohort 2-Placebo
2 patients with mild to moderate psoriasis will be randomized to receive matching placebo, applied twice daily for 4 consecutive weeks. The drug will be applied topically to the psoriasis site.
Drug: Placebo
Topical administration for twice daily
Other Name: Blank cream

Experimental: Cohort 3-Experimental
8 patients with mild to moderate psoriasis will be randomized to receive 2.0% Icotinib hydrochloride cream, applied twice daily for 4 consecutive weeks. The drug will be applied topically to the psoriasis site.
Drug: 2.0% Icotinib hydrochloride cream
Topical administration for twice daily
Other Name: no other name

Placebo Comparator: Cohort 3-Placebo
2 patients with mild to moderate psoriasis will be randomized to receive matching placebo, applied twice daily for 4 consecutive weeks. The drug will be applied topically to the psoriasis site.
Drug: Placebo
Topical administration for twice daily
Other Name: Blank cream

Experimental: Cohort 4-Experimental
8 patients with mild to moderate psoriasis will be randomized to receive 4.0% Icotinib hydrochloride cream, applied twice daily for 4 consecutive weeks. The drug will be applied topically to the psoriasis site.
Drug: 4.0% Icotinib hydrochloride cream
Topical administration for twice daily
Other Name: no other name

Placebo Comparator: Cohort 4-Placebo
2 patients with mild to moderate psoriasis will be randomized to receive matching placebo, applied twice daily for 4 consecutive weeks. The drug will be applied topically to the psoriasis site.
Drug: Placebo
Topical administration for twice daily
Other Name: Blank cream




Primary Outcome Measures :
  1. Safety in patients with mild to moderate psoriasis [ Time Frame: 28 days ]
    Incidence and severity of Adverse Events (AE), Physical Examinations, Vital signs (temperature, Heart Rate (HR), BP and respiration); Clinical laboratory assessments (serum chemistry, hematology, C-reactive protein , fecal and urinalysis); ECG;


Secondary Outcome Measures :
  1. Tolerance-related skin reactions in patients with mild to moderate psoriasis at the treatment site [ Time Frame: 28 days ]
    Skin irritation and allergy observation (including redness, swelling,rash, itching, pain) recorded by grades


Other Outcome Measures:
  1. Lesion severity [ Time Frame: 28 days ]
    Erythema , scale , thickness of target site on patients with mild to moderate psoriasis

  2. Lesion area [ Time Frame: 28 days ]
  3. Psoriasis Area and Severity Index (PASI) Scores in patients with mild to moderate psoriasis [ Time Frame: 28 days ]
  4. Physician's Global Assessment(PGA) in patients with mild to moderate psoriasis [ Time Frame: 28 days ]
  5. Dermatology Life Quality Index (DLQI) in patients with mild to moderate psoriasis [ Time Frame: 28 days ]
  6. Time maximum concentration observed(tmax) of single-dose Icotinib Hydrochloride Cream in patients with mild to moderate psoriasis [ Time Frame: 12 hours ]
  7. Peak plasma concentration (Cmax) of single-dose Icotinib Hydrochloride Cream in patients with mild to moderate psoriasis [ Time Frame: 12 hours ]
  8. Area under the plasma concentration versus time curve(AUC) of single-dose Icotinib Hydrochloride Cream from zero(0) hours to time (t) in patients with mild to moderate psoriasis [ Time Frame: 12 hours ]
  9. Area under the plasma concentration versus time curve(AUC) of single-dose Icotinib Hydrochloride Cream from zero (0) hours to infinity (∞) in patients with mild to moderate psoriasis [ Time Frame: 12 hours ]
  10. Half life(t1/2) of single-dose Icotinib Hydrochloride Cream in patients with mild to moderate psoriasis [ Time Frame: 12 hours ]
  11. Time maximum concentration observed(tmax) of repeat-dose Icotinib Hydrochloride Cream in patients with mild to moderate psoriasis [ Time Frame: 24 hours ]
  12. Stable peak plasma concentration (Cmaxss) of repeat-dose Icotinib Hydrochloride Cream in patients with mild to moderate psoriasis [ Time Frame: 24 hours ]
  13. Area under the plasma concentration versus time curve(AUC) of repeat-dose Icotinib Hydrochloride Cream from zero(0) hours to time (t) in patients with mild to moderate psoriasis [ Time Frame: 24 hours ]
  14. Area under the plasma concentration versus time curve(AUC) of repeat-dose Icotinib Hydrochloride Cream from zero (0) hours to infinity (∞) in patients with mild to moderate psoriasis [ Time Frame: 24 hours ]
  15. Half life(t1/2) of repeat-dose Icotinib Hydrochloride Cream in patients with mild to moderate psoriasis [ Time Frame: 24 hours ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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 diagnosis of plaque psoriasis for at least six months with multiple treatable area (i.e. the lesion should not only on the face, scalp, genitals or skinfolds) of plaque psoriasis covering less than 10% of the total Body Surface Area (BSA), affected area on the limb and/or trunk≥ 1% BSA. A Target Plaque Area (TPA)≥9 cm2, with a Target Plaque Severity Score(TPSS)≥ 5, and induration subscore≥2.
  • Male participants should be ≥ 50 kg, female participants should be ≥ 45 kg; BMI should be between 19 and 28 kg/m2 (inclusive)
  • In good health, with no history of diseases of major organs and no abnormality found on physical examination and vital signs
  • Non-allergic, with no known history of drug allergy
  • 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 study
  • Have signed a written informed consent before entering the study

Exclusion Criteria:

  • Psoriasis guttata, psoriasis punctata, erythrodermic psoriasis, pustular psoriasis, psoriasis arthritis
  • Any dermatological disease that might interfere psoriasis clinical evaluation or bring the subject in danger, or have other serious dermatological disease other than psoriasis.
  • Have received underlying treatments before entering the trial:

Topical anti-psoriasis treatment in 2 weeks, e.g. corticosteroids, retinoids acid, anthranol, tars, keratolytics. Vitamin D analogues or local immune regulator treatment in 4 weeks; Emollient or cosmetics in 24 hours; Any psoriasis vaccine, or have participated in any psoriasis vaccine trial; Biologics treatment in 12 weeks, e.g. Alefacept, Etanercept, Infliximab, Adalimumab, Ustekinumab, Efalizumab; Any phototherapy or systemic treatment in 4 weeks, e.g. corticosteroids, methotrexate, retinoids acids, ciclosporin; Long time exposure to natural light or artificial UV, or will have such exposure; Use of drug known to harm certain organ in 12 weeks; Participated in any clinical trial in 4 weeks, or have plan to participate any trial during treatment period;

  • Any clinically significant central nervous, cardiac, hepatic, renal, gastrointestinal, respiratory, metabolic or musculoskeletal system disease history, or other pathological/physiological condition that might disrupt the trial result
  • Alanine transaminase(ALT), aspartate aminotransferase (AST), total bilirubin>1.5 Upper Limit Normal (ULN), creatinine>ULN
  • History of postural hypotension, or allergic diseases (asthma, urticaria, atopic dermatitis or rhinitis)
  • Pulmonary disease demonstrated by chest X-ray examination
  • Physically or mentally disabled
  • Positive for Hepatitis B Surface Antigen (HBsAg), hepatitis C or anti-HIV test
  • Know allergic to active ingredient or excipient of the investigational product
  • Excessive smoker(>10 cigarettes per day), or excessive alcohol intake (>15g absolute alcohol per day, equal to 450ml beer, 150ml wine or 50ml low-alcohol Chinese liquor)
  • Excessive drinking of tea, coffee or caffein-containing beverage (>8 glasses per day)
  • Drug abuser
  • Poor compliance
  • Under gestation or lactation period
  • Other subject that in the investigator's opinion unsuitable to be enrolled

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): NCT02801435


Locations
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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
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Principal Investigator: Min Zheng The Second Affiliated Hospital of Zhejiang University School of Medicine (SAHZU)
Principal Investigator: Zourong Ruan The Second Affiliated Hospital of Zhejiang University School of Medicine (SAHZU)

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Responsible Party: Betta Pharmaceuticals Co., Ltd.
ClinicalTrials.gov Identifier: NCT02801435     History of Changes
Other Study ID Numbers: BD-ICC-I01
First Posted: June 15, 2016    Key Record Dates
Last Update Posted: July 17, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Betta Pharmaceuticals Co., Ltd.:
EGFR inhibitor
topical agent
psoriasis
phase 1
Additional relevant MeSH terms:
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Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases