atopic dermatitis
Conditions
Interventions
Skin care products containing Bioceramide (cleanser, skin toner and moisturizing gel) are applied twice a day for 28 days
Sponsors
Zenyaku Kogyo Co., LTD,
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Atopic dermatitis patients; 1)with slight severity condition, 2)who are no need for treatment by steroidal and immunosuppressant drugs, 3)who are Japanese females and males between 20 years to 54 years old, and 4)who understand in detail and have written consent for the study protocol.
Exclusion criteria
Exclusion 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| To evaluate the efficacy of skin care products containing Bioceramide based upon dermatological assessments, itch score, skin hydration and improvement grade of symptom | — |
Countries
Japan
Contacts
Public ContactMikiko Tanaka
Japan Aesthetic Dermatology Symposium Secretariat
Outcome results
None listed