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This open label study is to determine the safety profile of GK530G in a long-term treatment (up to 12 months) in subjects with acne vulgaris and to evaluate the efficacy of GK530G in a long-term treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GK530G | Experimental | GK530G is the fixed-dose combination gel of Adapalene and Benzoyl Peroxide, BPO |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GK530G | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Local Tolerability (Erythema) | Highest severity of Local tolerability scores worth than base line | 12 monhths |
| Local Tolerability (Scaling) | Highest severity of Local tolerability scores worth than base line | 12 months |
| Local Tolerability (Dryness) | Highest Severity of Local Tolerability Scores Worse Than Baseline | 12 months |
| Local Tolerability (Pruritus) | Highest Severity of Local Tolerability Scores Worse Than Baseline | 12 months |
| Local Tolerability (Stinging/Burning) | Highest Severity of Local Tolerability Scores Worse Than Baseline | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Changes From Baseline in Total Lesion Counts | Baseline, Weeks 1, 2, 4, and Months 2, 3, 6, 9, 12 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Galderma investigational site | Urayasu | Chiba | Japan | |||
| Galderma investigational site |
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436 subjects have been enrolled in 20 site in Japan: First subject included: May 16, 2013; last subject out: July 18, 2014
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| ID | Title | Description |
|---|---|---|
| FG000 | GK530G | the fixed-dose combination gel of Adapalene and Benzoyl Peroxide |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | GK530G | the fixed-dose combination gel of Adapalene and Benzoyl Peroxide |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Local Tolerability (Erythema) | Highest severity of Local tolerability scores worth than base line | Posted | Number | participants | 12 monhths |
|
|
12 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | GK530G | GK530G is the fixed-dose combination gel of Adapalene and Benzoyl Peroxide, BPO |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Peritonitis | Infections and infestations | MedDRA 15.0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA 15.0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Project Manager | Galderma K.K. | +81 3 5937 3850 | GaldermaKK.ClinDev@galderma.com |
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| ID | Term |
|---|---|
| D000152 | Acne Vulgaris |
| ID | Term |
|---|---|
| D017486 | Acneiform Eruptions |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012625 | Sebaceous Gland Diseases |
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| ID | Term |
|---|---|
| D001585 | Benzoyl Peroxide |
| ID | Term |
|---|---|
| D001565 | Benzoates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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| Fukuoka |
| Fukuoka |
| Japan |
| Galderma investigational site | Kawasaki | Kanagawa | Japan |
| Galderma investigational site | Yamato | Kanagawa | Japan |
| Galderma investigational site | Yokohama | Kanagawa | Japan |
| Galderma investigational site | Kumagaya | Saitama | Japan |
| Galderma investigational site | Chiyoda City | Tokyo | Japan |
| Galderma investigational site | Koto | Tokyo | Japan |
| Galderma investigational site | Machida | Tokyo | Japan |
| Galderma investigational site | Musashino | Tokyo | Japan |
| Galderma investigational site | Ōta-ku | Tokyo | Japan |
| Galderma investigational site | Shibuya City | Tokyo | Japan |
| Galderma investigational site | Shinjuku | Tokyo | Japan |
| Galderma investigational site | Suginami | Tokyo | Japan |
| Galderma investigational site | Tachikawa | Tokyo | Japan |
| Galderma investigational site | Kōtō City | Tpkyo | Japan |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
| Primary | Local Tolerability (Scaling) | Highest severity of Local tolerability scores worth than base line | Posted | Number | participants | 12 months |
|
|
|
| Primary | Local Tolerability (Dryness) | Highest Severity of Local Tolerability Scores Worse Than Baseline | Posted | Number | participants | 12 months |
|
|
|
| Primary | Local Tolerability (Pruritus) | Highest Severity of Local Tolerability Scores Worse Than Baseline | Posted | Number | participants | 12 months |
|
|
|
| Primary | Local Tolerability (Stinging/Burning) | Highest Severity of Local Tolerability Scores Worse Than Baseline | Posted | Number | subjects | 12 months |
|
|
|
| Secondary | Percent Changes From Baseline in Total Lesion Counts | Posted | Median | Full Range | percent change | Baseline, Weeks 1, 2, 4, and Months 2, 3, 6, 9, 12 |
|
|
|
| 6 |
| 436 |
| 311 |
| 436 |
| Tooth impacted | Gastrointestinal disorders | MedDRA 15.0 |
|
| Panic disorder | Psychiatric disorders | MedDRA 15.0 |
|
| Upper limb fracture | Injury, poisoning and procedural complications | MedDRA 15.0 |
|
| Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | MedDRA 15.0 |
|
| Abortion | Pregnancy, puerperium and perinatal conditions | MedDRA 15.0 |
|
| Ligament rupture | Injury, poisoning and procedural complications | MedDRA 15.0 |
|
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA 15.0 |
|
| Gastroenteritis | Infections and infestations | MedDRA 15.0 |
|
| Influenza | Infections and infestations | MedDRA 15.0 |
|
| Skin irritation | Skin and subcutaneous tissue disorders | MedDRA 15.0 |
|
| Pain of skin | Skin and subcutaneous tissue disorders | MedDRA 15.0 |
|
| Eczema | Skin and subcutaneous tissue disorders | MedDRA 15.0 |
|
| Dental caries | Gastrointestinal disorders | MedDRA 15.0 |
|
| Headache | Nervous system disorders | MedDRA 15.0 |
|
| Heat rash | Skin and subcutaneous tissue disorders | MedDRA 15.0 |
|
| Dysmenorrhoea | Reproductive system and breast disorders | MedDRA 15.0 |
|
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| D001555 |
| Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |