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A single arm, open-label study evaluating the safety and efficacy of ra148 in patients with atopic dermatitis.

A single arm, open-label study evaluating the safety and efficacy of ra148 in patients with atopic dermatitis. - A single arm, open-label study evaluating the safety and efficacy of ra148 in patients with atopic dermatitis.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000030265
Enrollment
12
Registered
2017-12-05
Start date
2017-12-18
Completion date
Unknown
Last updated
2026-06-29

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

Conditions

Atopic dermatitis

Interventions

Apply topical moisturizing ingredient containing cream (ra148) twice a day for 12 months.

Sponsors

MIE HIFUKA CLINIC
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Patients with atopic dermatitis who has mild or moderate rash and visits MIE HIFUKA CLINIC. 2) Those who can acquire written consent based on the voluntary intention before starting the study (For minors under the age of 20, in addition to their consent, the consent of the guardian in writing shall also be obtained). Priority is given to those who normally use Hirudoid (Maruho Co., Ltd.) formulation as a humectant.

Exclusion criteria

Exclusion criteria: 1) Patients with severe skin disorders on test site (both arms) and deemed inappropriate to participate in this study by the doctor. 2) Patients who have a history of hypersensitivity to heparin analog preparation. 3) Pregnant or lactating patients. Patients with suspicion of pregnancy. 4) Patients deemed inappropriate to participate in this study by the principal doctor or investigators. 5) Patients with hemorrhagic blood disease; e.g. Hemophilia, Thrombocytopenia, Purpura, etc. 6) Patients who are expected to promote serious consequences with minimal bleeding. 7) Patients who have undergone climacteric disorder or postmenopausal "hormone replacement therapy"

Design outcomes

Primary

MeasureTime frame
Evaluation of usefulness of long-term (12mo) application of ra148 on atopic disease by the principal doctor.

Secondary

MeasureTime frame
1) Severity classification (simple method) of atopic dermatitis developed by the advisory committee of atopic dermatitis severity classification of Japanese Dermatological Association at the test site. 2) Evaluation of the digital images of the test site. 3) Questionnaires for QOL assessment in atopic dermatitis. 4) Evaluation of the patient's diaries (Medication compliance, Subjective symptoms, The degree of itchiness, etc.).

Countries

Japan

Contacts

Public ContactAzumi Nagasawa, Ph.D.

Kao Corporation R&D - Core Technology -

nagasawa.azumi@kao.com0285-68-7706

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026