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A Multi-center, Randomized, Parallel Controlled Clinical Study of Nourishing Ultra-Rich Cream on the Improvement of Clinical Symptoms in Children With Atopic Dermatitis

A Multi-center, Randomized, Parallel Controlled Clinical Study of Nourishing Ultra-Rich Cream on the Improvement of Clinical Symptoms in Children With Atopic Dermatitis

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IOR-17014093
Enrollment
Unknown
Registered
2017-12-22
Start date
2017-12-18
Completion date
Unknown
Last updated
2018-01-29

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

Conditions

atopic dermatitis

Interventions

the experimental group:in remission phase,the experimental group use Nourishing Ultra-Rich Cream twice a day
Control group:Withdraw Nourishing Ultra-Rich Cream and drug

Sponsors

Beijing Children's Hospital, Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
2 Years to 12 Years

Inclusion criteria

Inclusion criteria: 1. Meet Williams diagnostic criteria; 2. Moderate atopic dermatitis (EASI score 7.1-21.0 points); IGA score 2 points; 3. Aged between 2 years-12 years, include 2 yearsthe gender is not limited; 4. The guardians of the subjects were willing to use the subjects in the whole study period according to the doctor's instructions; 5. No moisturizing agent was used in the 7 days before the subjects entered the group.The subjects were not treated with topical medication 14 days before entered the group, including calcineurin inhibitors (Tacrolimus or pimecrolimus forexternal use), Glucocorticoid preparation and outward applicate Anti histamine drug; 6. The subjects did not receive non-steroidal immunosuppressive agents 4 weeks before entered the group (such as ciclosporin, methotrexate) or Ultraviolet therapy;Glucocorticoid preparations were not used in the system; Anti histamine drugs were not used in the system; 7. Other similar products shall not be used throughout the research period; 8. The subjects signed the informed consent prior to the commencement of any specific inspection or operation procedures. Because the subjects were childrenan informed consent must be signed and agreed by children over 10 years of ageand parents must sign the informed consent for parent; parents must sign the Informed exemption for children between 2-10 years of ageand sign the informed consent.

Exclusion criteria

Exclusion criteria: 1. do not meet the Williams diagnostic criteria; 2. Acute erosion, exudation, secondary infection; 3. open skin infection(bacterialvirusfungous)occurs in the treatment region; 4. Subjects which is participating in other clinical study or participated other clinical study in the past 3 months; 5. moisturizing agent was used in the 7 days before the subjects entered the group.The subjects were treated with topical medication 14 days before entered the group, including calcineurin inhibitors (Tacrolimus or pimecrolimus for external use), Glucocorticoid preparation and outward applicate Anti histamine drug; 6. The subjects had received non-steroidal immunosuppressive agents 4 weeks before entered the group ( such as ciclosporin, methotrexate) or Ultraviolet therapy;Glucocorticoid preparations were used in the system; Anti histamine drugs were used in the system; 7. Severe disease of immune system (such as lymphoma, ADIS, Wiskott-Aldrich's syndrome) or history of malignant tumor; 8. Serious heart, liver and kidney disease; 9. Other skin disease occur in the treatment regionapart from atopic dermatitis; 10. Subject is allergic to Mometasone Furoate Cream or Subject product (Nourishing Ultra-Rich Cream); 11. The subject with low complianceor can not finish the follow-ups according to scheduleor Were not willing to follow the plan in the whole study period; 12. In any case or in the past / present treatment, the subject does not meet the requirements of the present study.

Design outcomes

Primary

MeasureTime frame
Investigators Global Assessment;

Secondary

MeasureTime frame
EASI score;CDQOL;Pruritus severity;dyssomnia evaluation;

Countries

China

Contacts

Public ContactMa Lin

Beijing Children's Hospital, Capital Medical University

bch_maleen@aliyun.com+86 13370115020

Outcome results

None listed

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