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An Opened, Non-controlled, Multi-center Study of M118102 in Subjects with Asteatosis

Phase 3
Completed
Conditions
Asteatosis
Registration Number
JPRN-jRCT1080223223
Lead Sponsor
Maruho Co.,Ltd.
Brief Summary

The efficacy of M118102 was confirmed as the effects of the soft ointment were maintained after switched to M118102. There were no safety issues associated with M118102.

Detailed Description

Not available

Recruitment & Eligibility

Status
completed
Sex
All
Target Recruitment
60
Inclusion Criteria

Asteatosis Patients

Exclusion Criteria

(1) Patients with a history of any of the following:
1) Serious allergy (shock, anaphylactic symptoms)
2) Allergy to heparinoid
3) Cutaneous hypersensitivity to topical medicines (such as contact dermatitis)
4) Hemorrhagic blood disorder (hemophilia , thrombocytopenia , purpura )

(2) Patients with the following concurrent diseases:
1) Patients with any disorders that should not be enrolled in the sutdy such as;
-severe cardiac disorders
-severe hepatic disorders
-severe pulmonary disorders
-severe gastrointestinal disorders
-severe blood disorders
2) Supervening skin disease on Asteatosis
3) Hemorrhagic blood disorder (hemophilia , thrombocytopenia , purpura )

(3) Pregnant women, women who may be pregnant, lactating women or women who wish to become pregnant or women who are unwilling to use a suitable method of contraception as directed by the principal investigator or sub-investigator.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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