Health Condition 1: L209- Atopic dermatitis, unspecified
Conditions
Interventions
Intervention1: FLORACOR GI: 500mg, one capsule in the morning and one capsule in the evening with a full glass of water, oral route of administration, for 90 days
Control Intervention1: Placebo: 500mg
Sponsors
Advanced Enzymes Technologies Ltd.
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients diagnosed with atopic dermatitis according to the criteria of Hanifin and Rajka 2. Patients with a SCORAD index between 20 to 40 3. Patients who use or are prescribed topical corticosteroids for the treatment of atopic dermatitis outbreaks 4. Individuals conscious of skin health 5. Patient or Patients legally acceptable representative or parent or legal guardian understands and can comply with clinical trial protocol requirements 6. Patients who, in the judgment of the investigator, are considered suitable for participation in this study
Exclusion criteria
Exclusion criteria: 1. Pregnant women, women desiring to become pregnant, or lactating women 2. Patients who have received immune suppressive or cytostatic therapy or systemic steroids within 1 month prior to the first intake 3. Patients who have undergone phototherapy or systemic therapy for AD within 1 month prior to the first intake 4. Patients with active infections of the skin 5. Patients with clinically relevant asthma requiring treatment with inhaled corticosteroids (FEV1 less than 70 percent) 6. Patients with an indigestibility of or allergy against the components of milk or lactose intolerance (previously known or detected in the allergy test) 7. Patients under long-term treatment with systemic steroids, depot steroids, long-acting antihistamines, tranquilizers, psychopharmaceuticals 8. Patients who have taken antihistamines or psychopharmaceuticals with antihistaminic effects, or applied steroid-containing cream to the forearms within the past 7 days before prick testing or those treated with Astemizole (Hismanal) within 4 weeks before testing, due to its long half-life 9. Patients with a history of surgery within the past 3 months 10. Patients with acute or chronic symptomatic heart disease or severe internal medical conditions 11. Patients diagnosed with a general physical or mental health condition (eg, diabetes, peptic ulcer, inflammatory bowel disease, depression, anxiety, insomnia) or any systemic disease that may pose a safety risk, interfere with dietary intake of the investigational product, or affect the assessment of study outcomes 12. Patients diagnosed with an autoimmune disease or who are immunocompromised due to a medical condition or medication use (eg, HIV, organ transplant, lymphoma, chemotherapy, chronic corticosteroids use) 13. Patients with immune-complex-induced immunopathies or malignant tumors 14. Patients with a history of alcohol, drug, or medication abuse 15. Patients who, in the judgment of the investigator, will be unlikely to comply with the requirements of this protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assessment of severity of AD 1. Changes in the SCORAD index [Time frame is Visit 1 (Screening) and Visit 6 (EOT)] 2. Investigators Global Assessment (IGA) [Time frame is Visit 2 (Enrolment) and Visit 4 to Visit 6 (EOT)]Timepoint: Day 0, 1, 30 and 86 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Change in Recap of atopic eczema (RECAP) Questionnaire [Time frame is Visit 2 (Enrolment) and Visit 4 to Visit 6 (EOT)] 2.The proportion of days of topical steroid use during flares within the follow up period [Time frame is Visit 1 (Screening) to Visit 7 (EOS)] 3.Evaluation of general skin health parameters [Time frame is Visit 2 (Enrolment) and Visit 6 (EOT)] 4.Evaluation of immunological markers [Time frame is Visit 2 (Enrolment) and Visit 6 (EOT)] 5.Determination of change in microbial composition and change in microbial diversity [Time frame is Visit 2 (Enrolment) and Visit 6 (EOT)]Timepoint: Day 0, 30, 60 and 86;6.Determination of change in vital signs of body [Time frame is Visit 1 (Screening) to Visit 6 (EOT)] 7.Assessment of change in hematological parameters [Time frame is Visit 2 (Enrolment) & Visit 4 to Visit 6 (EOT)] 8.Analysis of change in biochemical parameters random blood sugar total cholesterol total albumin and globulin [Time frame is Visit 2 (Enrolment) & Visit 4 to Visit 6 (EOT)] 9.Assessment of tolerability [Time frame is Visit 3(telephonic) to Visit 7 (EOS)] 10.Determination of rate of incidence of AEs and SAEs [Time frame is Visit 1 (Screening) to Visit 7 (EOS)Timepoint: Day 0, 30, 60 and 86 | — |
Countries
India
Contacts
Public ContactDr Nilisha Nalawade
Advanced Enzymes Technologies Ltd.
Outcome results
None listed