A Open-Label Phase 3, Multi-Center, Parallel Group Study to evaluate Efficacy and Safety of GK664S in Subjects with moderate-to-severe scalp Eczema Dermatitis except for seborrheic dermatitis.
Phase 3
Completed
- Conditions
- Scalp eczema dermatitis except for seborrheic dermatitis
- Registration Number
- JPRN-jRCT2080224185
- Lead Sponsor
- Maruho Co.,Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 60
Inclusion Criteria
Subjects with Scalp eczema dermatitisexcept for seborrheic dermatitis
Exclusion Criteria
(1)Subjects with a history of any of the following diseases
1)Serious drug allergy (shock, anaphylactic symptoms)
2)Allergy to corticosteroid
3)Cutaneous hypersensitivity to topical medicines (such as contact dermatitis)
(2)Subjects with the Clinically significant liver, kidney, heart, or lung diseases that require hospitalization
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method efficacy<br>Proportion of subjects with an IGA score of 0(clear) or 1(almost clear) and achieving >=2 grade improvement from Baseline at week4<br>Investigators assess the IGA score of the scalp eczema dermatitis from symptoms across the scalp.
- Secondary Outcome Measures
Name Time Method efficacy<br>Change from Baseline in individual sign scores of scalp eczema dermatitis and pruritus score<br>Investigators will assess the individual sign scores of scalp eczema dermatitis and let the subject evaluate pruritus score of scalp eczema dermatitis.