PsoriasisPhase 1NCT02801435
Icotinib Hydrochloride Cream in Patients With Mild to Moderate Psoriasis
A Phase 1 study testing 0.5% Icotinib hydrochloride cream, 1.0% Icotinib hydrochloride cream and 2.0% Icotinib hydrochloride cream in people with Psoriasis, run by Betta Pharmaceuticals Co., Ltd. at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Psoriasis
- What is being tested?
- 0.5% Icotinib hydrochloride cream, 1.0% Icotinib hydrochloride cream and 2.0% Icotinib hydrochloride cream
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 41 participants
- Where
- 1 siteChina
- Study dates
- 17 Sep 2016to 8 Jun 2017
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
China1 site
The Second Affiliated hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310009
About this study
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
This is a phase I study to evaluate the safety, tolerability and pharmacokinetics of Icotinib Hydrochloride Cream in patients with mild to moderate psoriasis.
Read the 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.
- Conditions
- Psoriasis
- Being tested
- 0.5% Icotinib hydrochloride cream, 1.0% Icotinib hydrochloride cream, 2.0% Icotinib hydrochloride cream, 4.0% Icotinib hydrochloride cream, Placebo
- Keywords
- EGFR inhibitor, topical agent, psoriasis, phase 1
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.5% Icotinib hydrochloride creamDrug
Also called no other name
Topical administration for twice daily
1.0% Icotinib hydrochloride creamDrug
Also called no other name
Topical administration for twice daily
2.0% Icotinib hydrochloride creamDrug
Also called no other name
Topical administration for twice daily
4.0% Icotinib hydrochloride creamDrug
Also called no other name
Topical administration for twice daily
PlaceboDrug
Also called Blank cream
Topical administration for twice daily
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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;
Measured: 28 days
Secondary outcomes (1)
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
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2016 (estimated)
- Study start17 Sep 2016
- Primary completion8 Jun 2017
- Study completion8 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- More trials run by Betta Pharmaceuticals Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Betta Pharmaceuticals Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Tigermed Consulting Co., Ltd
- Responsible party
- Sponsor
- Investigators
- Min Zheng, Principal investigator, The Second Affiliated Hospital of Zhejiang University School of Medicine (SAHZU)Zourong Ruan, Principal investigator, The Second Affiliated Hospital of Zhejiang University School of Medicine (SAHZU)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02801435
- Sponsor's protocol ID
- BD-ICC-I01
- Status last verified
- Jul 2017
- First submitted
- 11 Jun 2016
- Last updated
- 17 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02801435
- Acronym / sponsor ID
- BD-ICC-I01
- Conditions
- Psoriasis
- Keywords
- EGFR inhibitor, topical agent, psoriasis, phase 1
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Betta Pharmaceuticals Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Tigermed Consulting Co., Ltd
- Study start
- 17 Sep 2016 (actual)
- Primary completion
- 8 Jun 2017 (actual)
- Study completion
- 8 Jun 2017 (actual)
- First posted
- 15 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a phase I study to evaluate the safety, tolerability and pharmacokinetics of Icotinib Hydrochloride Cream in patients with mild to moderate psoriasis.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Cohort 1-Experimental | Experimental | Drug: 0.5% Icotinib hydrochloride cream8 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. |
| Cohort 1-Placebo | Placebo comparator | Drug: Placebo2 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. |
| Cohort 2-Experimental | Experimental | Drug: 1.0% Icotinib hydrochloride cream8 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. |
| Cohort 2-Placebo | Placebo comparator | Drug: Placebo2 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. |
| Cohort 3-Experimental | Experimental | Drug: 2.0% Icotinib hydrochloride cream8 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. |
| Cohort 3-Placebo | Placebo comparator | Drug: Placebo2 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. |
| Cohort 4-Experimental | Experimental | Drug: 4.0% Icotinib hydrochloride cream8 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. |
| Cohort 4-Placebo | Placebo comparator | Drug: Placebo2 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 0.5% Icotinib hydrochloride creamAlso: no other nameTopical administration for twice daily | Drug | Cohort 1-Experimental |
| 1.0% Icotinib hydrochloride creamAlso: no other nameTopical administration for twice daily | Drug | Cohort 2-Experimental |
| 2.0% Icotinib hydrochloride creamAlso: no other nameTopical administration for twice daily | Drug | Cohort 3-Experimental |
| 4.0% Icotinib hydrochloride creamAlso: no other nameTopical administration for twice daily | Drug | Cohort 4-Experimental |
| PlaceboAlso: Blank creamTopical administration for twice daily | Drug | Cohort 1-Placebo, Cohort 2-Placebo, Cohort 3-Placebo, Cohort 4-Placebo |
Primary outcome
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;
1 secondary outcome
Tolerance-related skin reactions in patients with mild to moderate psoriasis at the treatment site
Time frame: 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Min Zheng principal investigator
The Second Affiliated Hospital of Zhejiang University School of Medicine (SAHZU)
Zourong Ruan principal investigator
The Second Affiliated Hospital of Zhejiang University School of Medicine (SAHZU)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 0.5% Icotinib hydrochloride cream, 1.0% Icotinib hydrochloride cream and 2.0% Icotinib hydrochloride cream in people with Psoriasis, run by Betta Pharmaceuticals Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety in patients with mild to moderate psoriasis (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2017.