None listed
Conditions
Brief summary
The existing treatments to treat atopic dermatitis have limitations with side effects and long-term use. The medication called AKP-11, is an experimental topical formulation being investigated for its potential as a treatment for atopic dermatitis. The use of AKP-11 in this study is purely experimental. AKP-11 as ointment was applied to 10 psoriasis and 8 atopic dermatitis participants and no serious side effects were reported. The primary purpose of this study to to further determine a safety, tolerability and efficacy of topical doses of AKP-11 when administered to participants with atopic dermatitis.
Interventions
The administration involves two times a day topical application of AKP-11 ointments to participants with atopic dermatitis (AD) for up to 28 days. The 1 g ointment contains 0 mg or 30 mg of active AKP-11 contained in a sachet which will be applied twice daily to an allocated atopic dermatitis area as determined by the investigator. Participants are allocated to receive 0 mg (placebo) or 30 mg of AKP-11. The allocated area will be equal or less than 3% of treatable body surface area. During each
The administration involves two times a day topical application of AKP-11 ointments to participants with atopic dermatitis (AD) for up to 28 days. The 1 g ointment contains 0 mg or 30 mg of active AKP-11 contained in a sachet which will be applied twice daily to an allocated atopic dermatitis area as determined by the investigator. Participants are allocated to receive 0 mg (placebo) or 30 mg of AKP-11. The allocated area will be equal or less than 3% of treatable body surface area. During each application, the entire content of the study ointment will be applied thinly on the allocated atopic dermatitis area/s (~1.5mg/ cm2). After the study ointment has been applied in a uniform layer, the area will be thoroughly rubbed for approximately one minute. The application site can be covered with clothes after study ointment application.
Sponsors
Akaal Pharma PTY LTD
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
Males or females aged 18-65 years (inclusive) at the time of screening. Individuals diagnosed with atopic dermatitis according to the American Academy of Dermatology diagnostic features and with stable atopic dermatitis in both extent and severity for at least two weeks prior to commencement of study treatment. Individuals with mild to severe disease with less than or equal to 20% of body surface area (BSA; other than hair bearing scalp, palms of hands, soles and feet and genitals) with atopic dermatitis. Baseline Investigator’s Static Global Assessment (ISGA) score of mild (2) to severe (4). Participant is able to provide written informed consent prior to the performance of any study specific procedures. Participants with a BMI between 18 and 45.0 kg/m2, inclusive. 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) > 40 MIU/ml. Female participants of child-bearing potential with negative urine pregnancy test at screening and negative urine pregnancy test at Day 1, AND; Agree to abstinence for the duration of the study and until 4 weeks after dosing with study drug, if this is in line with the usual and preferred lifestyle; OR agree to use condoms plus one other acceptable form of contraception; i.e. intra-uterine device, hormonal contraception (oral, injected or implanted) or a female diaphragm, from screening until 4 weeks after dosing with study drug; OR has only same-sex partners; OR has a vasectomized partner, which should be the sole partner for that participant. Male participants with female partners of child-bearing potential must agree to abstinence if this is in line with the usual lifestyle, or to use condoms plus partner use of an acceptable contraceptive (intrauterine device, hormonal contraception such as oral, injected or implanted; or male condom plus female diaphragm or cervical cap) for the duration of the study and until 4 weeks after dosing with study drug. Negative test results for Human Immunodeficiency Virus (HIV), Hepatitis B and Hepatitis C at the time of screening. Negative drug screening test (drugs of abuse; Creatinine control, testing for amphetamines, barbiturates, cocaine, opiates, cannabinoids and benzodiazepines) result (urine test) at the time of screening. A 12-lead ECG at screening that in the opinion of the investigator, has no abnormalities that compromise subject’s safety in this study. Participants who are willing and able to comply with all study assessments and adhere to the protocol schedule.
Exclusion criteria
Participants with any skin condition other than atopic dermatitis, in particular cutaneous infections, significant sun damage or an inherited skin disorder that in the opinion of the Investigator could interfere with the evaluation of the trial medication. History of allergy and/ or hypersensitivity to any of the stated ingredients of the formulations. 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; systemic immunosuppressant agents (e.g. methotrexate, cyclosporine, azathioprine, thioguanine prednisone, prednisolone, hydroxyurea or mycophenolate mofetil, biologics); phototherapy or photochemotherapy; “alternative medicine” treatments; or deliberate abnormal sun exposure or tanning bed use, or any other therapy that in the opinion of the investigator could modify disease activity. Topical treatment within 2 weeks prior to commencement of study treatment and for the duration of the study to the area to be treated with the study ointment, including: topical corticosteroids; topical calcineurin inhibitor or any other topical treatments that in the opinion of the investigator could modify disease activity. 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. Have received an investigational vaccine within 6 months prior to baseline, or a live attenuated vaccine within 60 days prior to baseline, or intend to have a live vaccination during the course of the study (NB killed/inactive vaccines are allowed. Have clinical signs of active infection and/or a temperature of above 38.0 degrees at the time of screening. Study entry may be deferred at the discretion of the Principal Investigator. Anticipate surgery within the trial period or history of major surgery within 3 months of screening. A depot injection or an implant of any drug within 3 months prior to administration of study treatment, with the exception of a contraceptive implant. Participants who are unable to sign consent or unable to return for all scheduled study visits. Evidence of current or previous clinically significant neurological, endocrinal, cardiovascular, pulmonary, haematological, malignant, immunologic, psychiatric metabolic or other uncontrolled systemic disease, or finding of the medical examination (including vital signs and ECG), including any other condition that in the opinion of the investigator, would compromise the safety of the participant or interfere with assessment of endpoints or unsuitable for enrollment or impact on the quality of the data.
Outcome results
None listed