Effective prevention of atopic dermatitis by applying Fams baby

Phase 2

• Conditions: Atopic dermatitis

• Registration Number: JPRN-jRCTs031200070
• Lead Sponsor: Ohya Yukihiro

Brief Summary

Atopic dermatitis was observed in 11 (55%) of 20 infants in the group A (Fam's Baby twice daily), 5 (25%) of 20 in the group B (Fam's Baby once daily), and 10 (50%) of 20 in the group C (2e once daily) by 32 weeks of age, respectively. Although there was no statistically significant difference in the time to the first onset of atopic dermatitis between the groups, the group B tended to maintain intact skin for longer period than the group C.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-07-20
• Study Completion: 2022-04-05
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1) At the time of obtaining the consent, the newborn was less than 6 days old
2) A newborn with at least one parent or sibling who has had atopic dermatitis (high-risk newborn)
3) Newborn infants whose parents have given written informed consent after receiving the explanation

Exclusion Criteria

1) Newborn infants using topical drugs such as steroids (excluding the mouth, topical and anal areas )
2) Newborn infants with skin lesions such as abnormal keratinization and bullous disease
3) Newborn born less than 37 weeks in gestation
4) Newborn born by cesarean section
5) Multiple fetuses
6) Newborn with serious complications
7) If they plan to move during the study period and may not be able to visit the research facility
8) If the applicant cannot understand Japanese
9) In addition, if the investigator judges it inappropriate

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Disease-free period for atopic dermatitis

Secondary Outcome Measures

Name	Time	Method
Secondary outcome of effectiveness<br>1) EASI score at 4, 12, 24, and 32 weeks after birth<br>2) POEM scores POEM score during the study<br>3) Horny water content (SCH) at date of registration, 4, 12, 24, and 32 weeks after birth<br>4) Total IgE antibody titer, specific IgE antibody titer at the diagnosis of atopic dermatitis, or at 32 weeks after birth<br>5) Serum TARC level at diagnosis of atopic dermatitis or at 32 weeks after birth