Health Condition 1: null- Moderate to Severe Atopic Dermatitis
Conditions
Interventions
Intervention1: 1)Metaderm M1 Cream
2)Metaderm M5 Cream: Twice daily topical application
on lesion and adjacent non
lesion area for a period of 3
Months. The quantity of product
application will vary b
Sponsors
Haus Bioceuticals Inc
Eligibility
Inclusion criteria
Inclusion criteria: 1) Moderate to severe atopic dermatitis as determined by Physicianâ??s Global Assessment (PGA > 3) and SCORAD > 25 (SCORAD and PGA will incorporate whole body assessments) 2)Males and females, age 12 - 65 years old inclusive
Exclusion criteria
Exclusion criteria: 1) Is currently participating or has participated in another interventional clinical study at this or any other facility in the past 3 months. 2) Currently or has been diagnosed/treated for cancer in the past 5 years. 3) Requires any topical or systemic medications that could affect the course of their atopic dermatitis during the study period (except inhaled steroids and/or antihistamines for asthma or allergies). 4) Has a known hypersensitivity to any corticosteroid creams. 5) Has any active infections or has used antibiotics in the past 7 days. 6) Has any physical attributes or skin conditions that might interfere with the clear visual or instrumental assessments.(i.e. cuts, sunburn, birth marks, tattoos, extensive scarring, excessive hair growth or acne) 7) Has an immunologic or infectious disease (e.g. hepatitis, tuberculosis, HIV or AIDS, lupus rheumatoid arthritis) which could place the subject at risk or interfere with the accuracy of the study results. 8)Has used any immunosuppressant drugs or immunotherapy within the past 30 days or 5 half-lives. 9) Is an employee of the sponsor company or clinical testing site. 10) Is dependent on oral medication for any skin disease/condition or could not, in the opinion of the Investigator tolerate the restriction of discontinuing the medicine as required in this study. 11)Is currently pregnant or lactating or planning to become pregnant in the next 6 months (using double contraception for prevention). 12)Any other condition or factor the Investigator or their duly assigned representative believes may affect the ability of the subject to complete the study or the interpretation of the results.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Scoring of Atopic Dermatitis (SCORAD) score. [Time Frame: baseline to week 12]Timepoint: 12 Weeks for each subject | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of patients achieving a Physicianâ??s Global Assessment (PGA) score of 0 or 1 [Time Frame: baseline to week 12] Incidence of treatment emergent AE [Time Frame: baseline to week 12] Timepoint: 12 Weeks for each subject | — |
Countries
India
Contacts
Public ContactDr Rachana Shilpakar
MS clinical Research Pvt Ltd
Outcome results
None listed