NCT02801435

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
41

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Sep 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 11, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 15, 2016

Completed
3 months until next milestone

Study Start

First participant enrolled

September 17, 2016

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 8, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 8, 2017

Completed
Last Updated

July 17, 2017

Status Verified

July 1, 2017

Enrollment Period

9 months

First QC Date

June 11, 2016

Last Update Submit

July 12, 2017

Conditions

Psoriasis

Keywords

EGFR inhibitortopical agentpsoriasisphase 1

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Tolerance-related skin reactions in patients with mild to moderate psoriasis at the treatment site

    28 days

Other Outcomes (15)

  • Lesion severity

    28 days

  • Lesion area

    28 days

  • Psoriasis Area and Severity Index (PASI) Scores in patients with mild to moderate psoriasis

    28 days

  • +12 more other outcomes

Study Arms (8)

Cohort 1-Experimental

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

Cohort 1-Placebo

PLACEBO COMPARATOR

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

Cohort 2-Experimental

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

Cohort 2-Placebo

PLACEBO COMPARATOR

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

Cohort 3-Experimental

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

Cohort 3-Placebo

PLACEBO COMPARATOR

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

Cohort 4-Experimental

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

Cohort 4-Placebo

PLACEBO COMPARATOR

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

Interventions

0.5% Icotinib hydrochloride creamDRUG

Topical administration for twice daily

Also known as: no other name
Cohort 1-Experimental
1.0% Icotinib hydrochloride creamDRUG

Topical administration for twice daily

Also known as: no other name
Cohort 2-Experimental
2.0% Icotinib hydrochloride creamDRUG

Topical administration for twice daily

Also known as: no other name
Cohort 3-Experimental
4.0% Icotinib hydrochloride creamDRUG

Topical administration for twice daily

Also known as: no other name
Cohort 4-Experimental
PlaceboDRUG

Topical administration for twice daily

Also known as: Blank cream
Cohort 1-PlaceboCohort 2-PlaceboCohort 3-PlaceboCohort 4-Placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Second Affiliated hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310009, China

Location

MeSH Terms

Conditions

Psoriasis

Condition Hierarchy (Ancestors)

Skin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • 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)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 11, 2016

First Posted

June 15, 2016

Study Start

September 17, 2016

Primary Completion

June 8, 2017

Study Completion

June 8, 2017

Last Updated

July 17, 2017

Record last verified: 2017-07

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)