Clinical Trials List
2016-08-31 - 2018-12-31
Phase II
Terminated11
ICD-10L40.9
Psoriasis, unspecified
ICD-10L40
Psoriasis
Multi-center, randomized, vehicle-controlled, investigator-blinded, parallel groups study to evaluate the efficacy and safety of NP000888 in subjects with plaque and nail psoriasis
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Trial Applicant
GALDERMA HONG KONG LIMITED
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Sponsor
GALDERMA Research & Development SNC
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Trial scale
Taiwan Multiple Center
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Update
2025/08/20
Investigators and Locations
Co-Principal Investigator
- 林亦君 Division of Dermatology
- Chao-Kai Hsu Division of Dermatology
The Actual Total Number of Participants Enrolled
0 Completed
Audit
None
Co-Principal Investigator
- 阮昭奎 Division of Dermatology
The Actual Total Number of Participants Enrolled
0 Completed
Co-Principal Investigator
- 蕭百芬 Division of Dermatology
The Actual Total Number of Participants Enrolled
0 Completed
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Completed
Co-Principal Investigator
- 蔡昌霖 Division of Dermatology
The Actual Total Number of Participants Enrolled
0 Completed
Co-Principal Investigator
- Yi-Hsien Shih Division of Dermatology
The Actual Total Number of Participants Enrolled
2 Completed
Audit
CRO
Co-Principal Investigator
- Chung-Yao Hsu Division of Dermatology
- Hua-En Lee Division of Dermatology
- Yu-Huei Huang Division of Dermatology
- Ya-Ching Chang Division of Dermatology
- 林怡廷 Division of Dermatology
- 楊志勛 Division of Dermatology
- Wen-Hung Chung Division of Dermatology
- 吳吉妮 Division of Dermatology
The Actual Total Number of Participants Enrolled
16 Completed
Audit
None
Co-Principal Investigator
- Hsiou Hsin Tsai Division of Dermatology
The Actual Total Number of Participants Enrolled
0 Completed
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Completed
Audit
None
Co-Principal Investigator
- 蔡昌霖 Division of Dermatology
The Actual Total Number of Participants Enrolled
0 Completed
Co-Principal Investigator
- 蕭百芬 Division of Dermatology
The Actual Total Number of Participants Enrolled
0 Completed
Condition/Disease
Objectives
Test Drug
Active Ingredient
Dosage Form
Dosage
Endpoints
Primary efficacy endpoint
Success rate in IGA score (clear or almost clear) at Week 12 visit
Secondary efficacy endpoints
Percent change from baseline in total of plaque psoriasis PASI score at Week 12
visit
Distribution of IGA score
Distribution of change from baseline in IGA score at Week 12 visit
Nail Psoriasis endpoints
Primary efficacy endpoint
Percent change from baseline in total mtNAPSI scores at Week 24 visit
Secondary efficacy endpoints
Percent change from baseline in total NAPSI at Week 24 visit for all fingernails and
for affected fingernails only)
Distribution of fingernail PGA score and of its change from baseline at Week 24 visit
The safety parameters are Adverse Events (AEs), physical examination findings and
vital signs. In addition, laboratory parameters for routine clinical laboratory safety
profile and urinalysis will also be assessed
Inclution Criteria
1. Male or female, who is at least 20 years of age or older at Screening visit.
2. Subject with a clinical diagnosis of plaque psoriasis defined as an IGA score at least 2 (mild) (See protocol Section 7.1.1.1.1) at Screening and Baseline visits.
3. Subject with a plaque psoriasis total Body Surface Area (BSA) (See protocol Section 7.1.1.1.2) involvement of at least equal to 3% but less than 20% at Screening and Baseline visits.
4. Subject with a clinical diagnosis of fingernail psoriasis on at least 1 fingernail with a fingernail-PGA score from 2 (mild) to 4 (severe) (See Section 7.1.1.2.1) at Screening and Baseline visits.
5. Subject with stable plaque psoriasis with no flare during the month before Screening visit.
Exclusion Criteria
1. Subject with guttata, erythrodermic, exfoliative, inverse, pustular or palmo plantar, infected or ulcerated psoriasis or psoriasis involvement >or=20% BSA or an unstable form of psoriasis, defined as at least one flare in the previous month before Screening visit.
2. Subject with chronic plaque psoriasis who are candidates for systemic therapy at Screening and Baseline visits.
3. Subject with clinical signs of psoriatic arthritis at Screening and Baseline visits.
The Estimated Number of Participants
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Taiwan
60 participants
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Global
participants
