Effective prevention of atopic dermatitis by applying Fams baby

JRCT ID: jRCTs031200070

Registered date:20/07/2020

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Atopic dermatitis
• Date of first enrollment: 25/08/2020
• Target sample size: 60
• Study type: Interventional

Intervention(s)

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 )
Number of applications: Twice a day
Application period: From discharg e to 32 weeks after birth
Group B: Fam's Baby applied once 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 )
Number of applications: Once a day
Application period: From discharg e to 32 weeks after birth
Group C: 2e (due) applied once a day
Application site: The whole body except the scalp
Amount used once: 1 teaspoonful (4.0 g )
Number of applications: Once a day
Application period: From discharg e to 32 weeks after birth

Outcome(s)

• Primary Outcome: Disease-free period for atopic dermatitis

Secondary Outcome

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

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: < 1weeks old
• Gender: Both

Include 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

Exclude 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

Related Information

• Primary Sponsor: Ohya Yukihiro
• Source(s) of Monetary Support: Corporation Fams