Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study is to demonstrate the superiority in efficacy of the GK530G (fixed combination of CD0271 0.1% and CD1579 2.5%) versus each of the monads (CD0271 0.1% and CD1579 2.5%) in the treatment of acne vulgaris for up to 12 weeks, in the Japanese patients.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GK530G | Experimental | Fixed-dose combination gel of Adapalene and Benzoyl Peroxide |
|
| CD0271 | Active Comparator | Adapalene 01% Gel |
|
| CD1579 | Active Comparator | Benzoyl Peroxide 2.5% Gel |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GK530G | Drug |
|
| |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Changes From Baseline in Total Lesion Counts | Baseline - Week12 |
| Measure | Description | Time Frame |
|---|---|---|
| Percent of Subjects With Adverse Events | up to 12 weeks | |
| Local Tolerability (Erythema) | Highest severity of local tolerability scores worse than Baseline | 12 weeks |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Galderma investigational site | Chitose | Hokkaido | Japan | |||
| Galderma investigational site |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | CD0271 | Adapalene 01% Gel CD0271 |
| FG001 | GK530G | Fixed-dose combination gel of Adapalene and Benzoyl Peroxide GK530G |
| FG002 | CD1579 | Benzoyl Peroxide 2.5% Gel CD1579 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | GK530G | Fixed-dose combination gel of Adapalene and Benzoyl Peroxide GK530G |
| BG001 | CD0271 | Adapalene 01% Gel CD0271 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Posted | Median | Full Range | percent change | Baseline - Week12 |
|
12 weeks
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | CD0271 | Adapalene 01% Gel CD0271 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA 15.0 |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Project Manager | Galderma K.K | +81 3 5937 3850 | GaldermaKK.ClinDev@galderma.com |
Not provided
| ID | Term |
|---|---|
| D000152 | Acne Vulgaris |
| ID | Term |
|---|---|
| D017486 | Acneiform Eruptions |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012625 | Sebaceous Gland Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D001585 | Benzoyl Peroxide |
| D000068816 | Adapalene |
| D005782 | Gels |
| ID | Term |
|---|---|
| D001565 | Benzoates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| CD0271 |
| Drug |
|
|
| CD1579 | Drug |
|
|
| 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 |
| Kitami |
| Hokkaido |
| Japan |
| Galderma investigational site | Sapporo | Hokkaido | Japan |
| Galderma investigational site | Kagoshima | Kagoshima-ken | Japan |
| Galderma investigational site | Yokohama | Kanagawa | Japan |
| Galderma investigational site | Kurashiki | Okayama-ken | Japan |
| Galderma investigational site | Daitō | Osaka | Japan |
| Galderma investigational site | Neyagawa | Osaka | Japan |
| Galderma investigational site | Osaka | Osaka | Japan |
| Galderma investigational site | Sakai | Osaka | Japan |
| Galderma investigational site | Saitama | Saitama | Japan |
| Galderma investigational site | Adachi City | Tokyo | Japan |
| Galderma investigational site | Setagaya City | Tokyo | Japan |
| BG002 | CD1579 | Benzoyl Peroxide 2.5% Gel CD1579 |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|
| Participants |
|
|
| Secondary | Percent of Subjects With Adverse Events | 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 |
| 101 |
| 28 |
| 101 |
| EG001 | GK530G | Fixed-dose combination gel of Adapalene and Benzoyl Peroxide GK530G | 0 | 212 | 95 | 212 |
| EG002 | CD1579 | Benzoyl Peroxide 2.5% Gel CD1579 | 0 | 104 | 39 | 104 |
| Nasopharyngitis | Infections and infestations | MedDRA 15.0 |
|
| Pharyngitis | Infections and infestations | MedDRA 15.0 |
|
| Arthropod bite | Injury, poisoning and procedural complications | MedDRA 15.0 |
|
| Skin papilloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 |
|
| Headache | Nervous system disorders | MedDRA 15.0 |
|
| Dysmenorrhoea | Reproductive system and breast disorders | MedDRA 15.0 |
|
| Skin irritation | Skin and subcutaneous tissue disorders | MedDRA 15.0 |
|
| Eczema | Skin and subcutaneous tissue disorders | MedDRA 15.0 |
|
| Acne | Skin and subcutaneous tissue disorders | MedDRA 15.0 |
|
| Dermatitis atopic | Skin and subcutaneous tissue disorders | MedDRA 15.0 |
|
| Eyelid irritation | Eye disorders | MedDRA 15.0 |
|
| Conjunctivitis | Eye disorders | MedDRA 15.0 |
|
| Conjunctivitis allergic | Eye disorders | MedDRA 15.0 |
|
| Dry eye | Eye disorders | MedDRA 15.0 |
|
| Eye pruritus | Eye disorders | MedDRA 15.0 |
|
| Eyelid oedema | Eye disorders | MedDRA 15.0 |
|
| Gastritis | Gastrointestinal disorders | MedDRA 15.0 |
|
| Stomatitis | Gastrointestinal disorders | MedDRA 15.0 |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 15.0 |
|
| Cheilitis | Gastrointestinal disorders | MedDRA 15.0 |
|
| Periodontal disease | Gastrointestinal disorders | MedDRA 15.0 |
|
| Toothache | Gastrointestinal disorders | MedDRA 15.0 |
|
| Pyrexia | General disorders | MedDRA 15.0 |
|
| Fatigue | General disorders | MedDRA 15.0 |
|
| Seasonal allergy | Immune system disorders | MedDRA 15.0 |
|
| Gastrointestinal infection | Infections and infestations | MedDRA 15.0 |
|
| Body tinea | Infections and infestations | MedDRA 15.0 |
|
| Bronchitis | Infections and infestations | MedDRA 15.0 |
|
| Furuncle | Infections and infestations | MedDRA 15.0 |
|
| Gastroenteritis | Infections and infestations | MedDRA 15.0 |
|
| Herpes simplex | Infections and infestations | MedDRA 15.0 |
|
| Hordeolum | Infections and infestations | MedDRA 15.0 |
|
| Influenza | Infections and infestations | MedDRA 15.0 |
|
| Rhinitis | Infections and infestations | MedDRA 15.0 |
|
| Streptococcal infection | Infections and infestations | MedDRA 15.0 |
|
| Beta haemolytic streptococcal infection | Infections and infestations | MedDRA 15.0 |
|
| Oral herpes | Infections and infestations | MedDRA 15.0 |
|
| Subcutaneous abscess | Infections and infestations | MedDRA 15.0 |
|
| Tonsillitis | Infections and infestations | MedDRA 15.0 |
|
| Laceration | Injury, poisoning and procedural complications | MedDRA 15.0 |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA 15.0 |
|
| Scratch | Injury, poisoning and procedural complications | MedDRA 15.0 |
|
| Heat illness | Injury, poisoning and procedural complications | MedDRA 15.0 |
|
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA 15.0 |
|
| Blood triglycerides increased | Investigations | MedDRA 15.0 |
|
| Skin test positive | Investigations | MedDRA 15.0 |
|
| White blood cell count increased | Investigations | MedDRA 15.0 |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 15.0 |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 15.0 |
|
| Joint lock | Musculoskeletal and connective tissue disorders | MedDRA 15.0 |
|
| Ovarian neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 |
|
| Hyperaesthesia | Nervous system disorders | MedDRA 15.0 |
|
| Premenstrual syndrome | Reproductive system and breast disorders | MedDRA 15.0 |
|
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 |
|
| Rhinitis perennial | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 |
|
| Dermatitis allergic | Skin and subcutaneous tissue disorders | MedDRA 15.0 |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 15.0 |
|
| Blister | Skin and subcutaneous tissue disorders | MedDRA 15.0 |
|
| Eczema asteatotic | Skin and subcutaneous tissue disorders | MedDRA 15.0 |
|
| Heat rash | Skin and subcutaneous tissue disorders | MedDRA 15.0 |
|
| Hyperkeratosis | Skin and subcutaneous tissue disorders | MedDRA 15.0 |
|
| Papule | Skin and subcutaneous tissue disorders | MedDRA 15.0 |
|
| Photosensitivity reaction | Skin and subcutaneous tissue disorders | MedDRA 15.0 |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 15.0 |
|
| Seborrhoeic dermatitis | Skin and subcutaneous tissue disorders | MedDRA 15.0 |
|
| Skin erosion | Skin and subcutaneous tissue disorders | MedDRA 15.0 |
|
| Solar dermatitis | Skin and subcutaneous tissue disorders | MedDRA 15.0 |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 15.0 |
|
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA 15.0 |
|
| Dyshidrosis | Skin and subcutaneous tissue disorders | MedDRA 15.0 |
|
| Erythema multiforme | Skin and subcutaneous tissue disorders | MedDRA 15.0 |
|
| Onycholysis | Skin and subcutaneous tissue disorders | MedDRA 15.0 |
|
| Rash generalised | Skin and subcutaneous tissue disorders | MedDRA 15.0 |
|
Not provided
Not provided
| D001555 |
| Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D003102 | Colloids |
| D045424 | Complex Mixtures |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
| Title | Measurements |
|---|---|
|
| Severe |
|
| Title | Measurements |
|---|---|
|
| Severe |
|
| Title | Measurements |
|---|---|
|
| Severe |
|
| Title | Measurements |
|---|---|
|
| Severe |
|
| Title | Measurements |
|---|---|
|
| Severe |
|