Health Condition 1: L80-L99- Other disorders of the skin and subcutaneous tissue
Conditions
Interventions
Intervention1: EczePHx spray: Sufficient investigational product EczePHx will dispense to study subjects to cover the study treatment duration. Instruction for administration of study medicinal produ
Sponsors
Ms Krupa Parmar
Eligibility
Inclusion criteria
Inclusion criteria: Subject fulfilling all of the following criteria will be considered eligible for inclusion Male or female subject (including infants) having atopic dermatitis for at least 6 months, aged 6 months and older. Subject with mild to moderate atopic dermatitis/eczema diagnosed according to Hanifin and Rajka criteria (greater than or equal to 3 basic features and greater than or equal to 3 minor features), with SCORAD score greater than 25 and phenotypes: Subgroup A: Atopic dermatitis with diffuse dry skin, dry patches, slight erythema, and pruritus, but without eczema, oozing, or signs of skin infection Subgroup B: Atopic eczema with characteristic eczematous lesions Subgroup C: Atopic eczema with clinical signs and positive bacterial cultures of Staphylococcus aureus skin infection (e.g., meliceric or yellowish crusts at the skin surface) Females of childbearing potential must have a negative urine pregnancy test at baseline and must agree to use a potent contraceptive throughout the trial duration. Subject who is willing to participate and able to give written informed consent. Note: In case of child less than 7 years subjects, informed consent will be obtained from LAR (Legally Acceptable Representative/ Parents), for subject of age between 7-18 (child s assent will be obtained).
Exclusion criteria
Exclusion criteria: Subjects with SCORAD score 35. Subject using topical or systemic therapy for atopic dermatitis within specific washout period (Refer washout period section). Subject having any other dermatological or systemic condition which can interfere with outcomes of the study, on investigators discretion. Subjects with any skin condition on the treatment area which could confound efficacy measurements of study, on investigators discretion. Subject using any topical or systemic antibiotic. Subject having any known allergy to endolysin enzymes or allergic to any of the excipients of the investigational product; Subjects who are employees of the sponsor or are family members of an employee of the sponsor. For female subjects only Females who are pregnant, wishing to become pregnant during the study, or are breast feeding.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the efficacy of EczePHx spray in reducing disease severity in patients with mild to moderate atopic dermatitis, as measured by the SCORAD score over 14 days of treatment.Timepoint: Visit 1: screening (up to -7 days) Visit 2: baseline and randomization (Day 0) Visit 3: follow-up visit (day 3) 1 days Visit 4: follow-up visit (day 7) 1 days Visit 5: End of the study visit (day 14) 1 days | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the safety and tolerability of EczePHx spray in patients with mild to moderate atopic dermatitis over the 14-day treatment period.Timepoint: Visit 1: screening (up to -7 days) Visit 2: baseline and randomization (Day 0) Visit 3: follow-up visit (day 3) 1 days Visit 4: follow-up visit (day 7) 1 days Visit 5: End of the study visit (day 14) 1 days | — |
Countries
India
Contacts
Public ContactDr Jayati Dave
Arogya jain medical centre
Outcome results
None listed