Safety and efficacy of AKP-11 for atopic dermatitis.

INTERVENTION: The study involves the twice daily topical application of 1 g ointment containing 30 mg of active AKP‐11 or matching placebo to participants with atopic dermatitis for 4 weeks or one week post complete clearance, confirmed by the physician, whichever comes first when the AKP‐11 or placebo ointment will be applied twice daily. The target area of up to 300 cm2 ( 1.5 % of BSA). will be selected by investigator. At every visit, the participant will have to to return used and unused sachets to the study personal for accountability purposes. Participants will be randomized as groups of 2 (AKP‐11) and 1 (Placebo). CONDITION: Atopic Dermatitis PRIMARY OUTCOME: Change in Local Eczema Area and Severity Index (L‐EASI) score from the baseline, using a 4‐point severity scale. Change in Local‐Investigator Global assessment (L‐IGA) from baseline using 6‐point scale. Safety of 3% AKP‐11 ointment. This is assessed by drug related adverse events, physical examination, vital signs, ECG, laboratory assessment (haematology, plasma biochemistry, and urinalysis) and skin irritation assessment, as reported by investigator and by participant in study diary. SECONDARY OUTCOME: Change in Eczema Area and Severity Index (EASI) score from baseline. Change in pruritus score. The participant diaries will be provided to the participants that include the details how to score pruritus. Participant need to mark a line on a horizontal 10 cm long VAS scale. The study personnel will advise the participants how to mark the VAS scale during the Day 1 visit and ensure the participants are correctly marking VAS scale at every site visit. The participants will refer the table and imagine the intensity of pruritus they experience. Change in severity of atopic dermatitis, as assessed by SCORAD. 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 con