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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT01258088




Registration number
NCT01258088
Ethics application status
Date submitted
8/12/2010
Date registered
10/12/2010
Date last updated
5/03/2019

Titles & IDs
Public title
Safety Study of Ointment for the Treatment of Plaque-type Psoriasis
Scientific title
A Randomized, Double-blind, Vehicle-controlled, Multiple Cohort Study To Determine The Safety, Tolerability, And Pharmacokinetic Profile Of An2728 Ointment B, 2% In Healthy Volunteers And Patients With Mild-to-moderate Plaque-type Psoriasis
Secondary ID [1] 0 0
C3291010
Secondary ID [2] 0 0
AN2728-PSR-104
Universal Trial Number (UTN)
Trial acronym
AN2728-PSR-104
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Plaque-type Psoriasis 0 0
Condition category
Condition code
Skin 0 0 0 0
Dermatological conditions
Skin 0 0 0 0
Other skin conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - AN2728 Ointment
Treatment: Drugs - AN2728 Vehicle

Active Comparator: Cohort 1: AN2728 Ointment -

Placebo Comparator: Cohort 1: AN2728 Vehicle -

Active Comparator: Cohort 3: AN2728 Ointment -

Placebo Comparator: Cohort 3: AN2728 Vehicle -


Treatment: Drugs: AN2728 Ointment
5mg/cm2, BID

Treatment: Drugs: AN2728 Vehicle
5mg/cm2 BID

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Safety - 12-lead ECG, clinical laboratory tests, urinalysis, spontaneous/elicited adverse event (AE) reporting, local site reactions, physical exam and vital signs (blood pressure, heart rate).
Timepoint [1] 0 0
Up to 21 days
Secondary outcome [1] 0 0
Pharmacokinetic profile - Non-compartmental analysis of classic PK parameters: AUC(0-t), Cmax, Tmax, terminal t-1/2 (computed if data from majority of subjects permit) of AN2728, on Days 1 and 7 (or last day of administration). Trough plasma concentrations at the end of the dosing interval (Ctrough) collected at pre-morning dose.
Timepoint [1] 0 0
16 Days Maximum

Eligibility
Key inclusion criteria
- White males, 18 - 55 years (inclusive) of age at the time of randomization.

- Body weight between 60-90 kg (Body Mass Index [BMI] between 19 and 30 kg/m2
[inclusive]).

- Willing and able to comply with study instructions and commit to all follow-up visits.

- Have adequate venous access to permit repeated PK sampling.

- Ability to understand, agree to and sign the study Informed Consent Form (ICF) prior
to initiation of any protocol-related procedures.

- Non-smokers (refrained from any tobacco usage, including smokeless tobacco, nicotine
patches, etc., for 6 months prior to the administration of the study medication).

For psoriasis patients (in addition to the above criteria):

- Clinical diagnosis of stable plaque-type psoriasis with active plaques involving
5%-20% of total BSA excluding face, scalp and groin.
Minimum age
18 Years
Maximum age
55 Years
Gender
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
- History of serious adverse reactions or hypersensitivity to any drug; or known allergy
to any of the test product(s) or any components in the test product(s) or history of
hypersensitivity; or allergic reactions to any of the study preparations as described
in the Investigator's Brochure.

- Any clinically significant central nervous system (e.g., seizures), cardiac,
pulmonary, metabolic, renal, hepatic or gastrointestinal conditions or history of such
conditions that, in the opinion of the Investigator may place the subject at an
unacceptable risk as a participant in this trial or may interfere with the
distribution, metabolism or excretion of drugs.

- Abnormal physical findings of clinical significance at the Screening examination or
Baseline which would interfere with the objectives of the study.

- History of orthostatic hypotension (an increase in HR =20 bpm accompanied by a =20 mm
Hg drop in SBP and/or =10 mm Hg drop in DBP) present at Screening.

- Clinically significant abnormal laboratory values (as determined by the Investigator)
at the Screening evaluation.

- Presence or history of allergies requiring acute or chronic treatment (except seasonal
allergic rhinitis).

- 12-lead ECG obtained at Screening with: PR >240 msec, QRS >110 msec and QTc >450 msec,
bradycardia (<50 bpm) or clinically significant minor ST wave changes on the Screening
ECG, or any other changes on the Screening ECG that would interfere with measurement
of the QT interval.

- Major surgical interventions within 6 months of the study.

- Has a positive pre-study Hepatitis B surface antigen; positive Hepatitis C (HCV)
antibody or detectable HCV ribonucleic acid (RNA); or positive HIV antibody result.

- Use of prescription or non-prescription drugs, including vitamin supplements, herbal
and dietary supplements within 7 days or 5 half-lives (whichever is longer) prior to
the first dose of study medication, or use of St. John's Wort within 28 days prior to
the first dose of study medication. However, the Investigator and study team can
review medication use on a case by case basis to determine if its use would compromise
subject safety or interfere with study procedures or data interpretation. By
exception, the subject may take paracetamol or acetaminophen (=2 g/day) or ibuprofen
(=1600 mg/day) up to 48 h prior to the first dose of study medication.

- Has a history of regular alcohol consumption averaging >14 drinks/week (1 drink [100
mL wine or 280 mL standard strength beer or 30 mL of 80 proof distilled spirits])
within 6 months of the Screening visit.

- Loss of 500 mL blood or more during the 3 month period before the study, e.g., blood
donor.

- People that follow vegetarian or vegan diets.

- Symptoms of a significant somatic or mental illness in the four week period preceding
drug administration.

- History of drug abuse or dependence within 12 months of the study.

- Positive pre-study urine drug and alcohol screen. A minimum list of drugs that will be
screened for include benzodiazepines, opiates, methadone metabolite (EDDP),
sympathomimetic amines, cannabinoids, barbiturates, cocaine, and ethanol. (Suspected
false positive results may be repeated at the discretion of the Investigator.)

- Concurrent or recent (within 60 days) participation in another drug or device research
study.

- Considered by the Investigator to be unsuitable candidate for this study. Use of
AN2728 in a previous clinical trial.

For psoriasis patients (in addition to the above exclusion criteria):

- Spontaneously improving or rapidly deteriorating psoriatic plaques or
pustular/exfoliative, guttate, erythrodermic or other non-plaque form of psoriasis.

- Currently have drug-induced psoriasis (new onset or exacerbation of psoriasis from
beta blockers, calcium channel blockers, or lithium).

- Other serious skin disorder(s).

- Use of non-biologic systemic anti-psoriatic therapy (e.g., corticosteroids, PUVA, UVB,
retinoids, methotrexate, cyclosporine, other immunosuppressive agents) or biologic
therapy (e.g., alefacept, etanercept, adalimumab, ustekinumab) within four weeks prior
to enrollment or concurrently during the study.

- Use of topical treatments that have a known beneficial effect on psoriasis, including
but not limited to corticosteroids, retinoids, vitamin D derivatives, tar or
anthralin, within the past two weeks prior to enrollment or concurrently during the
study.

- Systemic medications for other medical conditions that are known to affect psoriasis
(e.g., lithium, beta adrenergic blockers) within the past four weeks prior to
enrollment or concurrently during the study.

- Use of emollients/moisturizers on area(s) to be treated within two days prior to
enrollment.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
CMAX (A Division of IDT Australia Ltd) - Adelaide
Recruitment postcode(s) [1] 0 0
5000 - Adelaide

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Pfizer
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to determine how much drug is absorbed throughout the body after
being applied to the skin.
Trial website
https://clinicaltrials.gov/show/NCT01258088
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Pfizer CT.gov Call Center
Address 0 0
Pfizer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications