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This study is to assess the efficacy and safety of two concentrations of CD1579 (2.5% and 5%) versus vehicle in the treatment of acne vulgaris in the Japanese patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CD1579 2.5% | Experimental | Benzoyl Peroxide 2.5% |
|
| CD1579 5% | Experimental | Benzoyl Peroxide 5% |
|
| Vehicle | Placebo Comparator | Vehicle |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CD1579 2.5% | Drug |
|
| |
| CD1579 5% |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Changes From Baseline in Total Lesion Counts | Median percent reductions from Baseline in total lesion count (ITT-LOCF) | Baseline - Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Percent of Subjects With Adverse Events | Adverse events which were observed in 5% or more patients with either group are listed. | up to 12 weeks |
| Local Tolerability (Erythema) | Highest severity of local tolerability scores worse than Baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Galderma investigational site | Fukuoka | Fukuoka | Japan | |||
| Galderma investigational site |
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| ID | Title | Description |
|---|---|---|
| FG000 | CD1579 2.5% | Benzoyl Peroxide 2.5% CD1579 2.5% |
| FG001 | CD1579 5% | Benzoyl Peroxide 5% CD1579 5% |
| FG002 | Vehicle | Vehicle Vehicle |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | CD1579 2.5% | Benzoyl Peroxide 2.5% CD1579 2.5% |
| BG001 | CD1579 5% | Benzoyl Peroxide 5% CD1579 5% |
| 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 | Percent Changes From Baseline in Total Lesion Counts | Median percent reductions from Baseline in total lesion count (ITT-LOCF) | Posted | Median | Full Range | percent change | Baseline - Week 12 |
|
12 weeks
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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 | CD1579 2.5% | Benzoyl Peroxide 2.5% CD1579 2.5% |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Compression fracture | Injury, poisoning and procedural complications | MedDRA 15.0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ear pruritus | Ear and labyrinth disorders | 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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| Drug |
|
|
| Vehicle | Drug |
|
| 12 weeks |
| Local Tolerability (Scaling) | Highest severity of local tolerability scores worse than Baseline | 12 weeks |
| Local Tolerability (Dryness) | Highest severity of local tolerability scores worse than Baseline | 12 weeks |
| Local Tolerability (Pruritus) | Highest severity of local tolerability scores worse than Baseline | 12 weeks |
| Local Tolerability (Stinging/Burning) | Highest severity of local tolerability scores worse than Baseline | 12 weeks |
| Amagasaki |
| Hyōgo |
| Japan |
| Galderma investigational site | Kobe | Hyōgo | Japan |
| Galderma investigational site | Nakano City | Tokyo | Japan |
| Galderma investigational site | Shibuya City | Tokyo | Japan |
| Galderma investigational site | Shinjuku | Tokyo | Japan |
| BG002 |
| Vehicle |
Vehicle Vehicle |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Percent of Subjects With Adverse Events | Adverse events which were observed in 5% or more patients with either group are listed. | Posted | Number | percentage of participants | up to 12 weeks |
|
|
|
| Secondary | Local Tolerability (Erythema) | Highest severity of local tolerability scores worse than Baseline | Posted | Number | participants | 12 weeks |
|
|
|
| Secondary | Local Tolerability (Scaling) | Highest severity of local tolerability scores worse than Baseline | Posted | Number | participants | 12 weeks |
|
|
|
| Secondary | Local Tolerability (Dryness) | Highest severity of local tolerability scores worse than Baseline | Posted | Number | participants | 12 weeks |
|
|
|
| Secondary | Local Tolerability (Pruritus) | Highest severity of local tolerability scores worse than Baseline | Posted | Number | participants | 12 weeks |
|
|
|
| Secondary | Local Tolerability (Stinging/Burning) | Highest severity of local tolerability scores worse than Baseline | Posted | Number | participants | 12 weeks |
|
|
|
| 0 |
| 79 |
| 34 |
| 79 |
| EG001 | CD1579 5% | Benzoyl Peroxide 5% CD1579 5% | 0 | 78 | 31 | 78 |
| EG002 | Vehicle | Vehicle Vehicle | 1 | 79 | 26 | 79 |
| Erythema of eyelid | Eye disorders | MedDRA 15.0 |
|
| Conjunctivitis allergic | Eye disorders | MedDRA 15.0 |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 15.0 |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 15.0 |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 15.0 |
|
| Toothache | Gastrointestinal disorders | MedDRA 15.0 |
|
| Vomiting | Gastrointestinal disorders | MedDRA 15.0 |
|
| Vessel puncture site haematoma | General disorders | MedDRA 15.0 | General disorders and administration site conditions |
|
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA 15.0 |
|
| Seasonal allergy | Immune system disorders | MedDRA 15.0 |
|
| Allergy to arthropod sting | Immune system disorders | MedDRA 15.0 |
|
| Nasopharyngitis | Infections and infestations | MedDRA 15.0 |
|
| Oral herpes | Infections and infestations | MedDRA 15.0 |
|
| Otitis externa | Infections and infestations | MedDRA 15.0 |
|
| Tinea pedis | Infections and infestations | MedDRA 15.0 |
|
| Acute tonsillitis | Infections and infestations | MedDRA 15.0 |
|
| Herpes simplex | Infections and infestations | MedDRA 15.0 |
|
| Influenza | Infections and infestations | MedDRA 15.0 |
|
| Laryngitis | Infections and infestations | MedDRA 15.0 |
|
| Pharyngitis | Infections and infestations | MedDRA 15.0 |
|
| Tinea versicolour | Infections and infestations | MedDRA 15.0 |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA 15.0 |
|
| Excoriation | Injury, poisoning and procedural complications | MedDRA 15.0 |
|
| Hand fracture | Injury, poisoning and procedural complications | MedDRA 15.0 |
|
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA 15.0 |
|
| Post-traumatic neck syndrome | Injury, poisoning and procedural complications | MedDRA 15.0 |
|
| Radius fracture | Injury, poisoning and procedural complications | MedDRA 15.0 |
|
| Arthropod bite | Injury, poisoning and procedural complications | MedDRA 15.0 |
|
| Thermal burn | Injury, poisoning and procedural complications | MedDRA 15.0 |
|
| Protein urine present | Investigations | MedDRA 15.0 |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 15.0 |
|
| Synovial cyst | Musculoskeletal and connective tissue disorders | MedDRA 15.0 |
|
| Headache | Nervous system disorders | MedDRA 15.0 |
|
| Dysmenorrhoea | Reproductive system and breast disorders | MedDRA 15.0 |
|
| Premenstrual syndrome | Reproductive system and breast disorders | MedDRA 15.0 |
|
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 |
|
| Upper respiratory tract inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 |
|
| Skin irritation | Skin and subcutaneous tissue disorders | MedDRA 15.0 |
|
| Drug eruption | Skin and subcutaneous tissue disorders | MedDRA 15.0 |
|
| Eczema | Skin and subcutaneous tissue disorders | MedDRA 15.0 |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 15.0 |
|
| Dermatitis allergic | Skin and subcutaneous tissue disorders | MedDRA 15.0 |
|
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA 15.0 |
|
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 15.0 |
|
| Eczema asteatotic | Skin and subcutaneous tissue disorders | MedDRA 15.0 |
|
| Urticaria chronic | Skin and subcutaneous tissue disorders | MedDRA 15.0 |
|
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|
| Headache |
|
| Dysmenorrhea |
|
| Title | Measurements |
|---|---|
|
| Severe |
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
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| Severe |
|
| Title | Measurements |
|---|---|
|