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A random, open, positive-drug parallel control, and multicenter clinical trail for Compound Lithospermum oil in the treatment of mild to moderate diaper dermatitis

A random, open, positive-drug parallel control, and multicenter clinical trail for Compound Lithospermum Oil in the treatment of mild to moderate diaper dermatitis

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1800020103
Enrollment
Unknown
Registered
2018-12-14
Start date
2018-12-20
Completion date
Unknown
Last updated
2019-01-14

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

Conditions

Diaper dermatitis

Interventions

Group 1:Compound Lithospermum oil
Group 2:ointment of zink oxide

Sponsors

Beijing Children's Hospital Affiliated to Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 1 Years

Inclusion criteria

Inclusion criteria: 1. To meet the diagnostic criteria of Western medicine for diaper dermatitis: The skin of diaper area is stimulated by urine, feces and repeated rubbing; Limited dermatitis in diaper area; 2. The severity of diaper dermatitis was mild or moderate; 3. aged < 12 months male and female; 4. The legal guardian of the subject can fully understand the purpose of the test, and voluntarily to participate in the clinical trial and sign the consent form.

Exclusion criteria

Exclusion criteria: 1) The subjects who used the similar products, oral antihistamines, antibiotics or other anti-inflammatory drugs, glucocorticoids and other external drugs on the lesion area one week before the study. 2) Skin lesion combined virus and fungal infection; 3) There are other skin diseases (such as atopic dermatitis, enteropathic acrodermatitis, etc.) besides the diaper area, which obviously affect the evaluation of the children with skin diseases; 4) Premature infants and malnourished children; 5) The children with severe primary diseases such as cardiovascular, cerebrovascular, liver, kidney, endocrine, immune, hematopoietic system and psychiatric diseases 6) Allergic to research drug ingredients; 7) Patients who are participating in or have participated in other clinical trials within 3 months; 8) Researchers think it is not suitable for the candidates.

Design outcomes

Primary

MeasureTime frame
The overall improvement rate of skin lesions;

Secondary

MeasureTime frame
The effective rate of skin lesions;The clinical cure rate of skin lesions;The clinical healing time of skin lesions;the difference of mean values of non-invasive skin parameters (TEWL, Cor, PH) at the lesion site;The difference of the total score of the Dermatitis Family Impact Questionnaire (DFI);

Countries

China

Contacts

Public ContactLin Ma

Beijing Children's Hospital Affiliated to Capital Medical University

bch_maleen@aliyun.com+86 13601305676

Outcome results

None listed

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