A Multicenter, Randomized, Double Blind, Placebo-controlled, Two-arm, Phase II Clinical study to evaluate Safety, Tolerability and Efficacy of Topical 1% AKP-11 in Atopic Dermatitis Participants.

Akaal Pharma Pty Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新: 2024年8月19日

试验速览

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•1. Participants with Atopic Dermatitis as per Hanifin and Rajika method will be taken in the study.
•2. Participants with Diagnosis of Mild to Moderate Atopic Dermatitis (AD) condition as per Scoring of Atopic Dermatitis (SCORAD) and Eczema Area and Severity Index (EASI) will be included in the study.
•3. Participants with at least one Atopic Dermatitis spot with baseline score of pruritus as high moderate to severe itch (VAS =6cm) with average pruritus of (VAS =6cm) over 3 consecutive days prior to baseline visit.
•4. Participants who will be able to provide written informed consent prior to the performance of any study specific procedures.

•1. Participants with history of allergy or hypersensitivity to any of the ingredients such as AK-119 free base, Propylene glycol, Stearic acid, Paraffin oil, Cetyl alcohol, Petrolatum jelly and Glyceryl monostearate.
•2. Participants with any skin condition other than Atopic dermatitis, such as cutaneous infections, skin cancer, significant sun damage or an inherited skin disorder that in the opinion of the Investigator could interfere with the evaluation of the trial medication.
•3. Participants suspected with COVID-19 symptoms.
•4. Topical treatment within 2 weeks prior to commencement of study treatment including: topical corticosteroids; topical calcineurin inhibitor, antihistamine or any other topical treatments that in the opinion of the investigator could modify disease activity.

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