PsoriasisPhase 1NCT02574091
Icotinib Hydrochloride Cream in Healthy Adults and Psoriasis Patients
A Phase 1 study testing 1% icotinib hydrochloride cream and 2% icotinib hydrochloride cream in people with Psoriasis, run by Betta Pharmaceuticals Co., Ltd. at 1 site in New Zealand.
Trial summary
This is a phase I study to evaluate the safety, tolerability and pharmacokinetics of Icotinib Hydrochloride Cream in healthy adults and patients with mild to moderate psoriasis. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Psoriasis
- What is being tested?
- 1% icotinib hydrochloride cream and 2% icotinib hydrochloride cream
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 1 siteNew Zealand
- Study dates
- 26 Nov 2015to 19 Feb 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- For Part 1-Healthy Participants
- 18-50 years old (inclusive), male or female
- Male participants should be ≥ 50 kg, female participants should be ≥ 45 kg; Body Mass Index (BMI) should be between 19 and 30 kg/m2 (inclusive)
- In good health, with no history of diseases of major organs and no BP, HR, ECG or respiratory abnormality on physical examination
- Adequate hepatic and renal function, as determined by clinical laboratory assessments of blood and urine
- Negative serum pregnancy test at Screening and negative urine pregnancy test at Day -1 for females of child bearing potential
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- Negative screen for drugs of abuse, alcohol, hepatitis B surface antigen (HBsAg), hepatitis C (HCV) and Human Immunodeficiency Virus (HIV) at screening; and negative drugs of abuse, alcohol pre dose on Day -1
- Have signed a written informed consent before entering the study
- For Part 2 - Patients with Psoriasis
- Clinical diagnosis of psoriasis for at least six months with multiple affected areas (excluding the face, scalp, genitals and groin) involving 2%-15% of the total Body Surface Area (BSA)
- 18-65 years old
- Male participants should be ≥ 50 kg, female participants should be ≥ 45 kg; BMI should be between 19 and 35 kg/m2 (inclusive)
- In good health, with no history of diseases of major organs and no BP, HR, ECG or respiratory abnormality on physical examination
- Adequate hepatic and renal function, as determined by clinical laboratory assessments of blood and urine
- Negative serum pregnancy test at Screening and negative urine pregnancy test at Day -1 for females of child bearing potential
- Negative screen for drugs of abuse, alcohol, HBsAg, HCV and HIV at screening; and negative drugs of abuse, alcohol pre dose on Day1
- Women of child-bearing potential must agree to use adequate contraception prior to study entry, for the duration of study participation, and for 90 days following completion of therapy
- Have signed a written informed consent before entering the study
Who cannot join
- For Part 1-Healthy Participants
- Any clinically significant central nervous system, cardiac, pulmonary, renal, gastrointestinal, respiratory, metabolic conditions (or history), or other pathological or physiological conditions that might interfere with the trial result
- History of postural hypotension
- Use of any topical agents (including non-medicated lotions such as sun screen, cosmetics, moisturizing lotion) at the administration site within a week before randomization
- History of serious skin diseases (as determined by the investigator); no presence of skin ulceration at the test area at the time of the Screening visit
- Current smoker, or a history of regular (more than weekly) use of tobacco- or nicotine-containing products within two months prior to screening
Show all 14Show fewer
- History of excessive alcohol intake (more than four standard drinks daily, on average) or use of recreational drugs within the last three months
- For Part 2 - Patients with Psoriasis
- Any clinically significant central nervous system, cardiac, pulmonary, renal, gastrointestinal, respiratory, metabolic conditions (or history), or other pathological or physiological conditions that might interfere with the trial result
- History of postural hypotension
- Use of any topical agents (including non-medicated lotions such as sun screen, cosmetics, moisturizing lotion) at the administration site within a week before randomization
- History of serious skin diseases (as determined by the investigator); no presence of skin ulceration at the test area at the time of the Screening visit
- Excessive smoker(≥10 cigarettes per day), or a history of regular (more than weekly) use of tobacco- or nicotine-containing products within two months prior to screening
- History of excessive alcohol intake (more than four standard drinks daily, on average) or use of recreational drugs within the last three months
Trial locations and contacts
1 site in 1 country.
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 Healthy Adult Participants, Followed by Patients With Mild to Moderate Psoriasis
This is a phase I study to evaluate the safety, tolerability and pharmacokinetics of Icotinib Hydrochloride Cream in healthy adults and 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 non-small-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, double-blind, placebo-controlled study of icotinib hydrochloride cream by topical administration. The study is designed in two parts in healthy subjects (part 1) followed by patients with mild to moderate psoriasis (part 2). 1% and 2% icotinib hydrochloride cream will be initially applied to healthy subjects. Once the study in healthy adults shows favorable safety and tolerability, a study in patients with mild to moderate psoriasis will be followed. Approximately 28 subjects will be enrolled, including 12 healthy subjects (Part 1) and 16 patients with psoriasis (Part 2).
- Conditions
- Psoriasis
- Being tested
- 1% icotinib hydrochloride cream, 2% 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.
1% icotinib hydrochloride creamDrug
Also called no other name
Topical administration for twice daily
2% 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 | 4 healthy adult participants will be randomized to receive 1% icotinib hydrochloride cream, applied twice daily for 7 consecutive days (final dose on the morning of Day 8).
The drug will be used topically to the back of each participant within an area of 15cm x 25cm. Receives: Drug: 1% icotinib hydrochloride cream |
| Cohort 1-Placebo | Placebo comparator | 2 healthy adult participants will be randomized to receive placebo (blank cream), applied twice daily for 7 consecutive days (final dose on the morning of Day 8).
The drug will be used topically to the back of each participant within an area of 15cm x 25cm. Receives: Drug: Placebo |
| Cohort 2-Experimental | Experimental | 4 healthy adult participants will be randomized to receive 2% icotinib hydrochloride cream, applied twice daily for 7 consecutive days (final dose on the morning of Day 8).
The drug will be used topically to the back of each participant within an area of 15cm x 25cm. Receives: Drug: 2% icotinib hydrochloride cream |
| Cohort 2-Placebo | Placebo comparator | 2 healthy adult participants will be randomized to receive matching placebo, applied twice daily for 7 consecutive days (final dose on the morning of Day 8).
The drug will be used topically to the back of each participant within an area of 15cm x 25cm. Receives: Drug: Placebo |
| Cohort 3-Experimental | Experimental | 6 patients with mild to moderate psoriasis will be randomized to receive 1% icotinib hydrochloride cream, applied twice daily for 13 consecutive days (final dose on the morning of Day 14).
The drug will be applied topically to the psoriasis site (excluding face, scalp, genital and groin) on the arms and/or legs and/or trunk only. Receives: Drug: 1% 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 13 consecutive days (final dose on the morning of Day 14).
The drug will be applied topically to the psoriasis site (excluding face, scalp, genital and groin) on the arms and/or legs and/or trunk only. Receives: Drug: Placebo |
| Cohort 4-Experimental | Experimental | 6 patients with mild to moderate psoriasis will be randomized to receive 2% icotinib hydrochloride cream, applied twice daily for 13 consecutive days (final dose on the morning of Day 14).
The drug will be applied topically to the psoriasis site (excluding face, scalp, genital and groin) on the arms and/or legs and/or trunk only. Receives: Drug: 2% 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 13 consecutive days (final dose on the morning of Day 14).
The drug will be applied topically to the psoriasis site (excluding face, scalp, genital and groin) on the arms and/or legs and/or trunk only. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events in healthy subjects
Incidence and severity of Adverse Events (AE) Vital signs (temperature, Heart Rate (HR), BP and respiration); Clinical laboratory assessments (serum chemistry, hematology and urinalysis); ECG; Use of concomitant medications
Measured: 8 days
Adverse events in patients with mild to moderate psoriasis
Incidence and severity of AEs; Vital signs (temperature, HR, BP and respiration); Clinical laboratory assessments (serum chemistry, hematology and urinalysis); ECG; Use of concomitant medications
Measured: 14 days
Secondary outcomes (22)
Tolerance-related skin reactions in healthy adult participants at the tested sites
Skin irritation and allergy observation (including redness, swelling, itching, pain)
Measured: 8 days
Tolerance-related skin reactions in patients with mild to moderate psoriasis at the tested sites
Skin irritation and allergy observation (including redness, swelling, itching, pain)
Measured: 14 days
To investigate peak plasma concentration (Cmax) of single-dose Icotinib Hydrochloride Cream in healthy adult participants
Measured: 8 days
To investigate time maximum concentration observed(tmax) of single-dose Icotinib Hydrochloride Cream in healthy adult participants
Measured: 8 days
To investigate area under the plasma concentration versus time curve(AUC) of single-dose Icotinib Hydrochloride Cream in healthy adult participants
AUClast, AUC0-inf will be assessed
Measured: 8 days
To investigate half life(t1/2) of single-dose Icotinib Hydrochloride Cream in healthy adult participants
Measured: 8 days
To investigate stable peak plasma concentration (Cmaxss) of repeat-dose Icotinib Hydrochloride Cream in healthy adult participants
Measured: 8 days
To investigate time maximum concentration observed(tmax) of repeat-dose Icotinib Hydrochloride Cream in healthy adult participants
Measured: 8 days
To investigate area under the plasma concentration versus time curve(AUC) of repeat-dose Icotinib Hydrochloride Cream in healthy adult participants
AUC0-12,AUClast, AUC0-inf will be assessed
Measured: 8 days
To investigate half life(t1/2) of repeat-dose Icotinib Hydrochloride Cream in healthy adult participants
Measured: 8 days
To investigate peak plasma concentration (Cmax) of single-dose Icotinib Hydrochloride Cream in patients with mild to moderate psoriasis
Measured: 14 days
To investigate time maximum concentration observed(tmax) of single-dose Icotinib Hydrochloride Cream in patients with mild to moderate psoriasis
Measured: 14 days
To investigate area under the plasma concentration versus time curve(AUC) of single-dose Icotinib Hydrochloride Cream in patients with mild to moderate psoriasis
AUClast, AUC0-inf will be assessed
Measured: 14 days
To investigate half life(t1/2) of single-dose Icotinib Hydrochloride Cream in patients with mild to moderate psoriasis
Measured: 14 days
To investigate stable peak plasma concentration (Cmaxss) of repeat-dose Icotinib Hydrochloride Cream in patients with mild to moderate psoriasis
Measured: 14 days
To investigate time maximum concentration observed(tmax) of repeat-dose Icotinib Hydrochloride Cream in patients with mild to moderate psoriasis
Measured: 14 days
To investigate area under the plasma concentration versus time curve(AUC) of repeat-dose Icotinib Hydrochloride Cream in patients with mild to moderate psoriasis
AUC0-12,AUClast, AUC0-inf will be assessed
Measured: 14 days
To investigate half life(t1/2) of repeat-dose Icotinib Hydrochloride Cream in healthy adult participants
Measured: 14 days
Psoriasis Area and Severity Index (PASI) Scores in patients with mild to moderate psoriasis
Measured: 14 days
Dose-toxicity correlation in single-dose and repeat-dose administration
If observable trends exist between dose applied (in Part 2 of the study) and toxicity and response parameters.
Measured: 14 days
Dermatology Life Quality Index (DLQI)
Measured: 14 days
Dose-response correlation in single-dose and repeat-dose administration
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2015 (estimated)
- Study start26 Nov 2015
- Primary completion19 Feb 2017
- Study completion19 Feb 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
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Betta Pharmaceuticals Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Quintiles, Inc.
- Responsible party
- Sponsor
- Investigators
- Christopher J Wynne, Study chair, Christchurch Clinical Studies Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02574091
- Sponsor's protocol ID
- BD-ICC-NZ-I01
- Status last verified
- Jul 2017
- First submitted
- 28 Sep 2015
- Last updated
- 13 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 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 Healthy Adult Participants, Followed by Patients With Mild to Moderate Psoriasis
- ClinicalTrials.gov ID
- NCT02574091
- Acronym / sponsor ID
- BD-ICC-NZ-I01
- Conditions
- Psoriasis
- Keywords
- EGFR inhibitor, topical agent, psoriasis, phase 1
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Betta Pharmaceuticals Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Quintiles, Inc.
- Study start
- 26 Nov 2015 (actual)
- Primary completion
- 19 Feb 2017 (actual)
- Study completion
- 19 Feb 2017 (actual)
- First posted
- 12 Oct 2015 (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 healthy adults and 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 non-small-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, double-blind, placebo-controlled study of icotinib hydrochloride cream by topical administration. The study is designed in two parts in healthy subjects (part 1) followed by patients with mild to moderate psoriasis (part 2). 1% and 2% icotinib hydrochloride cream will be initially applied to healthy subjects. Once the study in healthy adults shows favorable safety and tolerability, a study in patients with mild to moderate psoriasis will be followed. Approximately 28 subjects will be enrolled, including 12 healthy subjects (Part 1) and 16 patients with psoriasis (Part 2).
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: 1% icotinib hydrochloride cream4 healthy adult participants will be randomized to receive 1% icotinib hydrochloride cream, applied twice daily for 7 consecutive days (final dose on the morning of Day 8). The drug will be used topically to the back of each participant within an area of 15cm x 25cm. |
| Cohort 1-Placebo | Placebo comparator | Drug: Placebo2 healthy adult participants will be randomized to receive placebo (blank cream), applied twice daily for 7 consecutive days (final dose on the morning of Day 8). The drug will be used topically to the back of each participant within an area of 15cm x 25cm. |
| Cohort 2-Experimental | Experimental | Drug: 2% icotinib hydrochloride cream4 healthy adult participants will be randomized to receive 2% icotinib hydrochloride cream, applied twice daily for 7 consecutive days (final dose on the morning of Day 8). The drug will be used topically to the back of each participant within an area of 15cm x 25cm. |
| Cohort 2-Placebo | Placebo comparator | Drug: Placebo2 healthy adult participants will be randomized to receive matching placebo, applied twice daily for 7 consecutive days (final dose on the morning of Day 8). The drug will be used topically to the back of each participant within an area of 15cm x 25cm. |
| Cohort 3-Experimental | Experimental | Drug: 1% icotinib hydrochloride cream6 patients with mild to moderate psoriasis will be randomized to receive 1% icotinib hydrochloride cream, applied twice daily for 13 consecutive days (final dose on the morning of Day 14). The drug will be applied topically to the psoriasis site (excluding face, scalp, genital and groin) on the arms and/or legs and/or trunk only. |
| Cohort 3-Placebo | Placebo comparator | Drug: Placebo2 patients with mild to moderate psoriasis will be randomized to receive matching placebo, applied twice daily for 13 consecutive days (final dose on the morning of Day 14). The drug will be applied topically to the psoriasis site (excluding face, scalp, genital and groin) on the arms and/or legs and/or trunk only. |
| Cohort 4-Experimental | Experimental | Drug: 2% icotinib hydrochloride cream6 patients with mild to moderate psoriasis will be randomized to receive 2% icotinib hydrochloride cream, applied twice daily for 13 consecutive days (final dose on the morning of Day 14). The drug will be applied topically to the psoriasis site (excluding face, scalp, genital and groin) on the arms and/or legs and/or trunk only. |
| Cohort 4-Placebo | Placebo comparator | Drug: Placebo2 patients with mild to moderate psoriasis will be randomized to receive matching placebo, applied twice daily for 13 consecutive days (final dose on the morning of Day 14). The drug will be applied topically to the psoriasis site (excluding face, scalp, genital and groin) on the arms and/or legs and/or trunk only. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- For Part 1-Healthy Participants
- 18-50 years old (inclusive), male or female
- Male participants should be ≥ 50 kg, female participants should be ≥ 45 kg; Body Mass Index (BMI) should be between 19 and 30 kg/m2 (inclusive)
- In good health, with no history of diseases of major organs and no BP, HR, ECG or respiratory abnormality on physical examination
- Adequate hepatic and renal function, as determined by clinical laboratory assessments of blood and urine
Key exclusion criteria (14 listed)
- For Part 1-Healthy Participants
- Any clinically significant central nervous system, cardiac, pulmonary, renal, gastrointestinal, respiratory, metabolic conditions (or history), or other pathological or physiological conditions that might interfere with the trial result
- History of postural hypotension
- Use of any topical agents (including non-medicated lotions such as sun screen, cosmetics, moisturizing lotion) at the administration site within a week before randomization
- History of serious skin diseases (as determined by the investigator); no presence of skin ulceration at the test area at the time of the Screening visit
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 |
|---|---|---|
| 1% icotinib hydrochloride creamAlso: no other nameTopical administration for twice daily | Drug | Cohort 1-Experimental, Cohort 3-Experimental |
| 2% icotinib hydrochloride creamAlso: no other nameTopical administration for twice daily. | Drug | Cohort 2-Experimental, 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
Adverse events in healthy subjects
Time frame: 8 days
Incidence and severity of Adverse Events (AE) Vital signs (temperature, Heart Rate (HR), BP and respiration); Clinical laboratory assessments (serum chemistry, hematology and urinalysis); ECG; Use of concomitant medications
Adverse events in patients with mild to moderate psoriasis
Time frame: 14 days
Incidence and severity of AEs; Vital signs (temperature, HR, BP and respiration); Clinical laboratory assessments (serum chemistry, hematology and urinalysis); ECG; Use of concomitant medications
22 secondary outcomes
Tolerance-related skin reactions in healthy adult participants at the tested sites
Time frame: 8 days
Tolerance-related skin reactions in patients with mild to moderate psoriasis at the tested sites
Time frame: 14 days
To investigate peak plasma concentration (Cmax) of single-dose Icotinib Hydrochloride Cream in healthy adult participants
Time frame: 8 days
To investigate time maximum concentration observed(tmax) of single-dose Icotinib Hydrochloride Cream in healthy adult participants
Time frame: 8 days
To investigate area under the plasma concentration versus time curve(AUC) of single-dose Icotinib Hydrochloride Cream in healthy adult participants
Time frame: 8 days
To investigate half life(t1/2) of single-dose Icotinib Hydrochloride Cream in healthy adult participants
Time frame: 8 days
To investigate stable peak plasma concentration (Cmaxss) of repeat-dose Icotinib Hydrochloride Cream in healthy adult participants
Time frame: 8 days
To investigate time maximum concentration observed(tmax) of repeat-dose Icotinib Hydrochloride Cream in healthy adult participants
Time frame: 8 days
To investigate area under the plasma concentration versus time curve(AUC) of repeat-dose Icotinib Hydrochloride Cream in healthy adult participants
Time frame: 8 days
To investigate half life(t1/2) of repeat-dose Icotinib Hydrochloride Cream in healthy adult participants
Time frame: 8 days
To investigate peak plasma concentration (Cmax) of single-dose Icotinib Hydrochloride Cream in patients with mild to moderate psoriasis
Time frame: 14 days
To investigate time maximum concentration observed(tmax) of single-dose Icotinib Hydrochloride Cream in patients with mild to moderate psoriasis
Time frame: 14 days
To investigate area under the plasma concentration versus time curve(AUC) of single-dose Icotinib Hydrochloride Cream in patients with mild to moderate psoriasis
Time frame: 14 days
To investigate half life(t1/2) of single-dose Icotinib Hydrochloride Cream in patients with mild to moderate psoriasis
Time frame: 14 days
To investigate stable peak plasma concentration (Cmaxss) of repeat-dose Icotinib Hydrochloride Cream in patients with mild to moderate psoriasis
Time frame: 14 days
To investigate time maximum concentration observed(tmax) of repeat-dose Icotinib Hydrochloride Cream in patients with mild to moderate psoriasis
Time frame: 14 days
To investigate area under the plasma concentration versus time curve(AUC) of repeat-dose Icotinib Hydrochloride Cream in patients with mild to moderate psoriasis
Time frame: 14 days
To investigate half life(t1/2) of repeat-dose Icotinib Hydrochloride Cream in healthy adult participants
Time frame: 14 days
Psoriasis Area and Severity Index (PASI) Scores in patients with mild to moderate psoriasis
Time frame: 14 days
Dose-toxicity correlation in single-dose and repeat-dose administration
Time frame: 14 days
Dermatology Life Quality Index (DLQI)
Time frame: 14 days
Dose-response correlation in single-dose and repeat-dose administration
Time frame: 14 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 13 Jul 2017.
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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.
Christopher J Wynne study chair
Christchurch Clinical Studies Trust
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 1% icotinib hydrochloride cream and 2% icotinib hydrochloride cream in people with Psoriasis, run by Betta Pharmaceuticals Co., Ltd. at 1 site in New Zealand.
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 18 inclusion and 14 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 13 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 New Zealand. 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?
Adverse events in healthy subjects (time frame: 8 days). The study lists 2 primary outcomes in all. 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 13 Jul 2017.