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Effective prevention of atopic dermatitis by applying Fams baby

Effective prevention of atopic dermatitis by applying Fams baby twice daily and Fams baby once daily compared to 2e once daily in high-risk neonates A single center, randomized, blinded, parallel, 3 group, phase II trial

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs031200070
Enrollment
60
Registered
2020-07-20
Start date
2020-08-25
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atopic dermatitis Atopic dermatitis

Interventions

Group A: Fam's Baby applied twice a day Application site: The whole body except the scalp Amount used once: Size of a ping -pong ball (0.7 g /piece) with a total of 6 pieces (total 4.2 g ) Nu

Sponsors

Ohya Yukihiro
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
Disease-free period for atopic dermatitis

Secondary

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

Contacts

Public ContactYukihiro Ohya

National Center for Child Health and Development

ohya-y@ncchd.go.jp+81-3-3416-0181

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026