Anti-inflammatory treatment for dermatological disorders.

Phase 1

Completed

• Conditions: Inflammatory skin diseases; Psoriasis; Skin - Dermatological conditions

• Registration Number: ACTRN12613001226796
• Lead Sponsor: Akaal Pharma Pty Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-11-07
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 19

Inclusion Criteria

1.Males or females healthy or psoriasis patients aged from 18 upto 65 years at the time of screening.
2.Patients with mild to moderate chronic plaque-type psoriasis with a PASI score greater than 5 and less than 10 (based on diagnosis by a suitably qualified Investigator).
3.For psoriasis patients the duration of psoriasis of at least one year with stable disease in both extent and severity for at least two weeks prior to the commencement of study treatment.
4.Able to provide written informed consent prior to the performance of any study specific procedures.
5.Subjects with a BMI between 18.0 and 35.0 kg/m2.
6.Female subjects of non-childbearing potential, defined as (1) having a documented tubal ligation at least 6 weeks prior to dosing; (2) having had a surgical bilateral oophorectomy (with or without hysterectomy); (3) at least 12 months of spontaneous amenorrhoea with follicle stimulating hormone (FSH) greater than 40 MIU/ml.
7.Female subjects of child-bearing potential with negative serum pregnancy test at screening and negative urine pregnancy test at check-in (Day -1), AND; Agrees to abstinence for the duration of the study and until 4 weeks after dosing with study drug; OR agrees to use condoms plus one other acceptable form of contraception; ie. intra-uterine device, hormonal contraception or a female diaphragm, from screening until 4 weeks after dosing with study drug; OR has only same-sex partners, when this is her preferred and usual lifestyle.
8.Male subjects with female partners of child-bearing potential must agree abstinence or to use condoms plus partner use of an acceptable contraceptive (intrauterine device, hormonal contraception or male condom plus female diaphragm) for the duration of the study and until 4 weeks after dosing with study drug.
9.Negative Human Immunodeficiency Virus (HIV), Hepatitis B and Hepatitis C Screening test results.
10.Subjects who are willing and able to comply with all study assessments and adhere to the protocol schedule.

Exclusion Criteria

1.Subjects with erythrodermic, guttate, palmar, plantar or generalised pustular forms of psoriasis or subjects with scalp, palmar or plantar psoriasis only.
2.Subjects with any skin condition other than psoriasis, in particular eczema, cutaneous infections, significant sun damage or an inherited skin disorder (other than psoriasis).
3. History of allergy and/ or hypersensitivity to any of the stated ingredients of the formulations.
4.A history of moderate to severe asthma during the last 10 years.
5.Major chronic inflammatory disease e.g rheumatoid arthritis, Crohn’s disease, SLE.
6.Congenital or acquired immunodeficiency or cancer prone syndrome.
7.History of abnormal bleeding tendencies or thrombophlebitis unrelated to venepuncture or intravenous cannulation, or a history of Hepatitis B, Hepatitis C or HIV infection.
8.Subjects who have smoked more than 10 cigarettes a day in the last 12 months
9.History of malignancy (other than adequately treated skin carcinoma or carcinoma-in-situ of the cervix).
10.Treatment with any of the following within 4 weeks prior to the commencement of study treatment and for the duration of the study: systemic retinoids; immunosuppressant agents (e.g. methotrexate, cyclosporine, azathioprine, thioguanine prednisone, prednisolone, hydroxyurea or mycophenolate mofetil); phototherapy or photochemotherapy; high potency topical corticosteroids; alternative medicine” treatments for psoriasis; or prolonged sun exposure or tanning bed use, which may in the opinion of the Investigator, modify disease activity.
11.Topical treatment within 2 weeks prior to commencement of study treatment and for the duration of the study, including: moderate potency topical corticosteroids; vitamin D analogues and topical retinoids; or keratolytics, coal tar and dithranol.
12.Have received any investigational research agent or therapeutic biologic within 30 days or 5 half-lives (whichever is longer) prior to the first dose of Investigational Product.
13.Have received an investigational vaccine within 6 months, a live attenuated vaccine within 60 days or a registered vaccine within 30 days prior to the first dose of the Investigational Product.
14.Use of any of the following prescription drugs: beta-blockers, diltiazem, verapamil, anti-arrhythmic drugs. Other prescription drugs may be allowed at the discretion of the Principal Investigator.
15.Any clinically significant history or presence of neurological, endocrinal, cardiovascular, pulmonary, hematological, malignant, immunologic, psychiatric, metabolic or other uncontrolled systemic disease, with the exclusion of psoriasis.
16.Have a bleeding disorder diagnosed by a doctor (e.g. factor deficiency, coagulopathy, or platelet disorder requiring special precautions) or significant bruising or bleeding difficulties with IM injections or blood draws.
17.Have a psychiatric condition that precludes compliance with the protocol; past or present psychoses; past or present bipolar disorder; disorder requiring lithium; or within five years prior to enrolment, a history of suicide plan.
18.Any clinically significant abnormality at Screening determined by medical history, physical examination, blood chemistry, haematology, urinalysis and a 12-lead ECG.
19.History of drug or alcohol abuse within the 12 months prior to dosing, or evidence of such abuse as indicated by the laboratory assays conducted during screening and baseline.
20.Any other condition whic

Study & Design

• Study Type: Interventional
• Study Design: Not specified