Evaluation of the usefulness of CICAPLASTBaumeB5+ on dry skin of atopic dermatitis

JRCT ID: jRCTs031240600

Registered date:09/01/2025

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: atopic dermatitis
• Date of first enrollment: 09/01/2025
• Target sample size: 60
• Study type: Interventional
• Intervention(s): investigational new drug

Outcome(s)

• Primary Outcome: Comparison of efficacy in maintaining remission (relapse prevention) in both forearms, and safety of the drugs under evaluation and comparator drugs
• Secondary Outcome: Local SCORAD, instrumental measurements (TEWL, water content), photography, left/right superiority comparison, VAS, product use questionnaire survey

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: < 65age old
• Gender: Both

Include criteria

1. Persons who have indicated their willingness to participate in the study, understood the explanation, and agreed in writing (written consent) to participate in the study.
2. Male and female atopic dermatitis patients between the ages of 18 and 65 years who do not meet the exclusion criteria.
3. Patients with atopic dermatitis who were diagnosed as having atopic dermatitis by their physician at the time of screening, based on observation of systemic skin symptoms and interview, in accordance with the Guidelines for the Diagnosis and Treatment of Atopic Dermatitis 2024 edited by the Japanese Dermatological Association1)
4. Those with no inflammatory symptoms on both forearms and only dry skin maintained with medical moisturizers for at least 2 weeks are classified as group A or B. Those with minor or mild inflammatory symptoms and dry skin maintained with medical moisturizers on both forearms for at least 2 weeks are classified as group B.
5. Patients with inflammatory symptoms requiring topical anti-inflammatory treatment on both forearms at screening, who have been promptly treated with anti-inflammatory therapy under the supervision of the principal investigator and have been introduced to maintenance therapy with medical moisturizer for dry skin at least 2 weeks prior to study entry.
6. Patients who are able to fill out the consent form, questionnaire survey, daily log of use, and other documents.
7. Those who are able to come to the facility on the designated observation days.

Exclude criteria

1. who have obvious edema, papules, exudates, or crusts at the site of evaluation
2. who have clinical signs of other skin diseases at the evaluation site
3. who are currently pregnant or within 6 months postpartum (for female research subjects)
4. other subjects deemed unsuitable for inclusion in the study by the principal investigator

Related Information

• Primary Sponsor: Fujiyama Mika
• Source(s) of Monetary Support: NIHON LOREAL K.K.