Icotinib Hydrochloride Cream in Patients With Mild to Moderate Psoriasis

Psoriasis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02801435
• Other study ID #: BD-ICC-I01
• Status: Completed
• Phase: Phase 1
• First received: June 11, 2016
• Last updated: July 12, 2017
• Start date: September 17, 2016
• Est. completion date: June 8, 2017

Study information

• Verified date: July 2017
• Source: Betta Pharmaceuticals Co.,Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: June 8, 2017
• Est. primary completion date: June 8, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Psoriasis

Intervention

Drug:
• 0.5% Icotinib hydrochloride cream
Topical administration for twice daily
• 1.0% Icotinib hydrochloride cream
Topical administration for twice daily
• 2.0% Icotinib hydrochloride cream
Topical administration for twice daily
• 4.0% Icotinib hydrochloride cream
Topical administration for twice daily
• Placebo
Topical administration for twice daily

Locations

Country	Name	City	State
China	The Second Affiliated hospital of Zhejiang University School of Medicine	Hangzhou	Zhejiang

Sponsors (2)

Lead Sponsor	Collaborator
Betta Pharmaceuticals Co.,Ltd.	Tigermed Consulting Co., Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Lesion severity	Erythema , scale , thickness of target site on patients with mild to moderate psoriasis	28 days
Other	Lesion area		28 days
Other	Psoriasis Area and Severity Index (PASI) Scores in patients with mild to moderate psoriasis		28 days
Other	Physician's Global Assessment(PGA) in patients with mild to moderate psoriasis		28 days
Other	Dermatology Life Quality Index (DLQI) in patients with mild to moderate psoriasis		28 days
Other	Time maximum concentration observed(tmax) of single-dose Icotinib Hydrochloride Cream in patients with mild to moderate psoriasis		12 hours
Other	Peak plasma concentration (Cmax) of single-dose Icotinib Hydrochloride Cream in patients with mild to moderate psoriasis		12 hours
Other	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		12 hours
Other	Area under the plasma concentration versus time curve(AUC) of single-dose Icotinib Hydrochloride Cream from zero (0) hours to infinity (8) in patients with mild to moderate psoriasis		12 hours
Other	Half life(t1/2) of single-dose Icotinib Hydrochloride Cream in patients with mild to moderate psoriasis		12 hours
Other	Time maximum concentration observed(tmax) of repeat-dose Icotinib Hydrochloride Cream in patients with mild to moderate psoriasis		24 hours
Other	Stable peak plasma concentration (Cmaxss) of repeat-dose Icotinib Hydrochloride Cream in patients with mild to moderate psoriasis		24 hours
Other	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		24 hours
Other	Area under the plasma concentration versus time curve(AUC) of repeat-dose Icotinib Hydrochloride Cream from zero (0) hours to infinity (8) in patients with mild to moderate psoriasis		24 hours
Other	Half life(t1/2) of repeat-dose Icotinib Hydrochloride Cream in patients with mild to moderate psoriasis		24 hours
Primary	Safety in patients with mild to moderate psoriasis	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;	28 days
Secondary	Tolerance-related skin reactions in patients with mild to moderate psoriasis at the treatment site	Skin irritation and allergy observation (including redness, swelling,rash, itching, pain) recorded by grades	28 days