Health Condition 1: L209- Atopic dermatitis, unspecified
Conditions
Interventions
Intervention1: 1% AKP-11 ointment: dose: 1%,
dosage form: ointment,
route: topical,
frequency: 1-7 days (TID), 7-14 days(BID),
treatment duration: 14 days,
sudy duration: 21 days.
Control Interv
Sponsors
Akaal Pharma Pty Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Percentage change in Scoring of Atopic Dermatitis (SCORAD). 2. Percentage change in Eczema Area and Severity Index (EASI). 3. Proportion of participants with an improvement of pruritus on VAS scale.Timepoint: Baseline (Day 1) to EOT | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Proportion of participants with an Investigator Global Assessment (IGA) success defined as: • =2 point improvement 2. Safety of AKP-11 ointment.Timepoint: Baseline (Day 1) to EOT | — |
Countries
India
Contacts
Public ContactDr Harish S
ICBio Clinical Research Pvt Ltd
Outcome results
None listed