ACTRN12616000294459
Completed
N/A
A Phase I, safety, tolerability and efficacy study of topical AKP-11 administration to participants with atopic dermatitis.
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Atopic Dermatitis
- Sponsor
- Akaal Pharma PTY LTD
- Enrollment
- 21
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\*Males or females aged 18\-65 years (inclusive) at the time of screening.
- •\*Individuals diagnosed with atopic dermatitis according to the criteria of Hanifin and Rajka.
- •\*Individuals with mild to moderate disease and equal to 10 % of BSA with atopic dermatitis.
- •\*Participants with L\-EASI score of equal to 1 for each of the signs at an appropriate target site.
- •\*Able to provide written informed consent proper to the performance of any study specific procedures.
- •\*Participants with a BMI between 18\.0 and 40\.0 kg/m2, inclusive.
- •\*Female participants of child\-bearing potential with negative 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, if this is in line with the usual and preferred lifestyle;
- •\*OR agrees 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, when this is her preferred and usual lifestyle;
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.
- •\*Participants who have smoked more than 10 cigarettes a day in the last 12 months.
- •\*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; or 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, including: moderate potency topical corticosteroids; topical retinoids; or keratolytics, coal tar and dithranol or any other topical 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, a live attenuated vaccine within 60 days or a registered vaccine within 30 days prior to the first dose of the Investigational Product.
- •\*Have evidence of drug or alcohol abuse within 6 months prior to screening visit (i.e., more than fourteen units of alcohol per week \[1 Unit \= 150 ml of wine 360 ml of beer, or 45 ml of 40% alcohol]).
- •\*Have clinical signs of active infection and/or a temperature of above 38\.0 degrees of C 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.
Outcomes
Primary Outcomes
Not specified
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