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EFFICACY AND SAFETY OF ATODERM INTENSIVE ON SUBJECTS WITH MILD ATOPIC DERMATITIS: MULTICENTER, OPEN CLINICAL STUDY

EFFICACY AND SAFETY OF ATODERM INTENSIVE ON SUBJECTS WITH MILD ATOPIC DERMATITIS: MULTICENTER, OPEN CLINICAL STUDY

Status
Recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1800014321
Enrollment
Unknown
Registered
2018-01-05
Start date
2018-01-03
Completion date
Unknown
Last updated
2018-01-08

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

Conditions

Mild atopic dermatitis

Interventions

Case series:application Atoderm Intensive Baume

Sponsors

Peking University People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: All subjects should satisfy the inclusive criteria below: 1. Subject aged from 18 to 75 (male or female); 2. Subject diagnosed as atopic by the UK Working Partys diagnostic criteria which is made by the China Atopic Dermatitis diagnosis and therapy guideline (2014); 3. Subjects with SCORAD ranging from 10 to 25 (including 10 and 25); 4. Subject who volunteer to participate in this study and signed the written informed consent form (ICF); 5. Subject who understand the contents of study and is able to participate in the study (determined by the investigator); 6. Subject who agrees to stop applying his/her habitual emollient and cleanser during the whole study period; 7. Subjects that did not take oral anti-inflammatory drugs within 4 weeks prior to enrollment in the study; 8. Subjects that did not applied anti-inflammatory drugs within 2 weeks before the enrollment in the study; 9. Subjects that did not take antihistamine 3 days before the enrollment in the study.

Exclusion criteria

Exclusion criteria: 1. Subject presenting AD with severe infection, cutaneous damage, effusion; 2. Subject presenting a cutaneous pathology other than AD (according to the investigators appreciation); 3. Subject presenting systemic diseases other than skin diseases that are not controlled by a medical doctor; 4. Pregnant woman or breast-feeding woman; 5. If the atopic subject need to use systemic glucocorticoid treatment for AD and/or other allergic symptoms; 6. Subject who will not stop his/her medication that is not permitted in the clinical study; 7. Subject with history of malignancy, HIV infection, autoimmune diseases and severe diabetes; 8. Subject with history of angina, severe cardiovascular and cerebrovascular complications, anaphylactic shock; 9. Subject participating in other clinical study before the screening visit (Day 0, D0) is not qualify for this study; 10. Subject with documented allergies to study product components; 11. Subject enrolled in another clinical trial during the study period; 12. Other conditions that the investigators considered that are not suitable for the clinical study; 13. Subject considered by the investigator to be unlikely to comply with the study protocol.

Design outcomes

Primary

MeasureTime frame
Severity of atopic dermatitis;

Countries

China

Contacts

Public ContactAustin Zhang

BIODERMA(China)Co., Ltd.

z.zhang@cn.naos.com+86 15618986311

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026