A safety study of skin care products containing Bioceramide in atopic dermatitis patients
- Conditions
- atopic dermatitis
- Registration Number
- JPRN-UMIN000022638
- Lead Sponsor
- Zenyaku Kogyo Co., LTD,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 35
Not provided
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Measures
Name Time Method To evaluate the efficacy of skin care products containing Bioceramide based upon dermatological assessments, itch score, skin hydration and improvement grade of symptom