A safety study of skin care products containing Bioceramide in atopic dermatitis patients

UMIN ID: UMIN000022638

Registered date:08/06/2016

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: atopic dermatitis
• Date of first enrollment: 2016/06/08
• Target sample size: 35
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): Skin care products containing Bioceramide (cleanser, skin toner and moisturizing gel) are applied twice a day for 28 days

Outcome(s)

• Primary Outcome: To evaluate the safety of skin care products containing Bioceramide based upon 1) frequency, types and severity of adverse events, and 2) results of safety assessments by dermatologists
• Secondary Outcome: To evaluate the efficacy of skin care products containing Bioceramide based upon dermatological assessments, itch score, skin hydration and improvement grade of symptom

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 54years-old
• Gender: Male and Female
• Exclude criteria: 1)Patients with an evidence of skin inflammation caused by atopic dermatitis or with the other skin disease that would interfere with clinical evaluation 2)Patients with any known allergies and hypersensitivity to any of the ingredients of the test products 3)Patients with underlying disease who need a admission to a hospital 4)Patients taking steroidal or immunosuppressant drugs for atopic dermatitis 5)Patients with history of participation in another clinical study within six (6) months 6)Women who are pregnant or breastfeeding, and women of reproductive potential who are not willing to use adequate contraception during study 7)Patients who are not willing to observe the limitation or prohibit matters 8)Patients who are judged inappropriate to participate by investigators.

Related Information

• Primary Sponsor: Zenyaku Kogyo Co., LTD,
• Source(s) of Monetary Support: Zenyaku Kogyo Co., LTD,