Moisturizing effect and safety of Allantoin combination spray.

Not Applicable

• Conditions: atopic dermatitis

• Registration Number: JPRN-jRCTs031190163
• Lead Sponsor: Higuchi Ayako

Brief Summary

The drug under study was confirmed to have improved skin moisturizing ability in patients with atopic dermatitis from skin findings, skin device measurement and skin component analysis. In addition, sufficient safety was confirmed.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-12-18
• Study Completion: 2020-02-26
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1) The atopic dermatitis patients that remission maintenance is possible just to use a moisturizer for a whole body (Include the patients who use the external preparation for anti-inflammatory for a part of the whole body).
2) The patients who continues remission maintenance more than four weeks.
3) The patients who have a skin drying part.
4) The patients aged 20-49 at consent.
5) The patients with written consent about this study entry.

Exclusion Criteria

1) Subjects who have the skin disease except the target disease and other diseases that it is thought that the diseases affect this study.
2) Subjects who have the injury that it is thought that the diseases affect this study or exanthem is the one in the observation part.
3) Subjects who is thought that the drug (systemic steroid, immunosuppressive drug, dupilumab preparation, et al) to influence on this study is necessary within four weeks before study start or in future.
4) Subjects who have the contact dermatitis with the past for cosmetics.
5) Pregnant or possibly pregnant women, breastfeeding women, or women who wish to become pregnant during study participation.
6) Subjects who participated in other clinical studies in the past 3 months.
7) In addition, subjects that it is judged by responsible doctor that participation in final examination is inappropriate.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The skin drying findings (drying, scale, desquamation) by the dermatologist.

Secondary Outcome Measures

Name	Time	Method
1) Change over time of the itch score.<br>2) The skin measurement by device ( corner layer water content, transepidermal water loss ).<br>3) Tape stripping (lipid analysis, cytokine analysis).<br>4) Photography.<br>5) The use situation of the study drug.<br>6) Questionary survey.