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The primary objectives of the study is to show CD2475/101 40mg tablets taken once a day for 16 weeks is superior to the placebo in Change from baseline to Week 16(Last Observation Carry Forward, Intent To Treat) in inflammatory lesion counts.
Investigator's global assessment and lesion count will be performed at each study visit.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CD2475/101 40 mg | Experimental | Participants receive 40 mg of CD2475/101 oral tablet plus placebo capsule orally once daily for 16 weeks. |
|
| Doxycycline 100 mg | Active Comparator | Participants receive 100 mg of Doxycycline capsule plus placebo tablet orally once daily for 16 weeks. |
|
| Placebo | Placebo Comparator | Participants receive matching placebo tablet plus placebo capsule orally once daily for 16 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CD2475/101 40 mg | Drug | Participants receive 40 mg of CD2475/101 tablets once a day for 16 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Inflammatory Lesion Counts to Week 16 (Last Observation Carried Forward [LOCF]) | The Inflammatory lesion count was the count of papules and pustules: papule was a small, solid elevation less than 0.5 cm in diameter, pustule was a small, circumscribed elevation of the skin that contains yellow-white exudate. Change from baseline in inflammatory lesion counts to Week 16 (LOCF) were reported. | From Baseline up to Week 16 (LOCF) |
| Measure | Description | Time Frame |
|---|---|---|
| Investigator Global Assessment (IGA) Success Rate at Week 16 (Last Observation Carried Forward [LOCF]) | IGA scale consisted of 5 grades (0-4) among which 0= Clear (no evidence of papules or pustules [inflammatory lesions]), 1= Almost clear (rare non-inflamed papules (papules must be resolving and hyperpigmented, though not pink-red), 2= Mild (few inflammatory lesions [papules/pustules only; no nodulo-cystic lesions]), 3=Moderate (multiple inflammatory lesions evident: many papules/pustules; up to two nodulocystic lesions), 4= Severe (inflammatory lesions are more apparent, many papules/pustules, few nodulo-cystic lesions). Success rate was defined as percentage of participants who achieved an Investigator Global Assessment (IGA) score of 1 (almost clear) or 0 (Clear) and at least a 2-grade improvement from Baseline to Week 16 (LOCF). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael Graeber, MD | Galderma R&D | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Burke Pharmaceutical Research | Hot Springs | Arkansas | 71913 | United States | ||
| Dermatology Research Associates, Inc. |
A total of 662 participants randomized the study and dispensed with study drug out of which 487 completed study.
This study was conducted in United States between 29 March 2011 (first participant first visit) to 3 January 2012 (last participant last visit).
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| ID | Title | Description |
|---|---|---|
| FG000 | CD2475/101 40 mg | Participants received 40 milligrams (mg) of CD2475/101 oral tablet plus placebo capsule orally once daily for 16 weeks. |
| FG001 | Doxycycline 100 mg | Participants received 100 mg of Doxycycline capsule plus placebo tablet orally once daily for 16 weeks. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Doxycycline 100 mg | Drug | Participants receive 100 mg of Doxycycline capsule once a day for 16 weeks |
|
| Placebo | Drug | Participants receive matching placebo tablet, matching placebo capsule once a day for 16 weeks. |
|
| Week 16 (LOCF) |
| Percent Change From Baseline in Inflammatory Lesion Counts to Week 16 (Last Observation Carried Forward [LOCF]) | The Inflammatory lesion count was the count of papules and pustules: papule was a small, solid elevation less than 0.5 cm in diameter, pustule was a small, circumscribed elevation of the skin that contains yellow-white exudate. Percent change from baseline in inflammatory lesion counts to Week 16 (LOCF) were reported. | From Baseline up to Week 16 (LOCF) |
| Percent Change From Baseline in Total Lesion Counts to Week 16 (Last Observation Carried Forward [LOCF]) | Total lesions were the sum of inflammatory lesion counts, non-inflammatory lesion counts, nodules and cysts. Percentage change from baseline in total lesion counts to Week 16 were reported. | From Baseline up to Week 16 (LOCF) |
| Change From Baseline in Non-Inflammatory Lesion Counts to Week 16 (Last Observation Carried Forward [LOCF]) | The non-inflammatory lesion count was the count of open and closed comedones: Open comedone was a pigmented dilated pilosebaceous orifice (blackhead). Closed comedone was a tiny white papule (whitehead). Change from baseline in non-inflammatory lesion counts to week 16 were reported | From Baseline up to Week 16 (LOCF) |
| Global Assessment for Inflammatory Lesions of Truncal Acne at Baseline, Week 12, and Week 16 | Global assessments for inflammatory lesions of truncal acne were done separately on back and chest. The global assessments severity scale included 5 grades (0-4): where in 0= Clear-no evidence of papules or pustules (inflammatory lesions), 1= Almost clear- rare non-inflamed papules (papules must be resolving and may be hyperpigmented, though not pink-red), 2=Mild- few inflammatory lesions (papules/pustules only; no nodulo-cystic lesions), 3=Moderate- multiple inflammatory lesions evident: many papules/pustules; may be a few nodulocystic lesions, 4=Severe- inflammatory lesions are more apparent, many papules/pustules, may be a few nodulo-cystic lesions. | Baseline, Week 12, and Week 16 |
| Number of Participants With at Least One Adverse Event (AE) | An AE was any untoward medical occurrence in a participant or clinical investigation participants administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. Number of participants with at least one AE were reported. | From Baseline up to Week 16 |
| Los Angeles |
| California |
| 90045 |
| United States |
| Colorado Medical Research Center | Denver | Colorado | 80210 | United States |
| Longmont Medical Research Network | Longmont | Colorado | 80501 | United States |
| International Dermatology Research, Inc. | Miami | Florida | 33144 | United States |
| MedaPhase, Inc. | Newnan | Georgia | 30263 | United States |
| Dermatology Specialists PC | Louisville | Kentucky | 40202 | United States |
| Somerset Skin Care Center | Troy | Michigan | 48084 | United States |
| Grekin Skin Care | Warren | Michigan | 48088 | United States |
| Central Dermatology, PC | St Louis | Missouri | 63117 | United States |
| Skin Specialists, PC | Omaha | Nebraska | 68144 | United States |
| Academic Dermatology | Albuquerque | New Mexico | 87106 | United States |
| Helendale Dermatology & Medical Spa | Rochester | New York | 14609 | United States |
| Dermatology Consulting Services | High Point | North Carolina | 27262 | United States |
| PMG Research of Wilmington | Wilmington | North Carolina | 28401 | United States |
| Haber Dermatology & cosmetic Surgery, Inc | South Euclid | Ohio | 44118 | United States |
| Central Sooner Research | Norman | Oklahoma | 73069 | United States |
| Oregon Dermatology & Research Center | Portland | Oregon | 97210 | United States |
| Stephen Schleicher | Hazleton | Pennsylvania | 18201 | United States |
| Palmetto Clinical Trial Services, LLC | Greenville | South Carolina | 29607 | United States |
| Dermatology Research Associates | Nashville | Tennessee | 37203 | United States |
| Tennessee Clinical Research Center | Nashville | Tennessee | 37215 | United States |
| Arlington Center for Dermatology | Arlington | Texas | 76011 | United States |
| Derm Research, Inc | Austin | Texas | 78759 | United States |
| J&S Studies | College Station | Texas | 77845 | United States |
| Suzanne Bruce and associates P.A. The Center for skin Research | Houston | Texas | 77056 | United States |
| Center for Clinical Studies | Houston | Texas | 77058 | United States |
| Progressive Clinical Research | San Antonio | Texas | 78229 | United States |
| Stephen Miller MD | San Antonio | Texas | 78229 | United States |
| Dermatology Research Center | Salt Lake City | Utah | 84124 | United States |
| Premier Clinical Research | Spokane | Washington | 99204 | United States |
| FG002 | Placebo | Participants received matching placebo tablet plus placebo capsule orally once daily for 16 weeks. |
| COMPLETED |
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| NOT COMPLETED |
|
|
Intent-to-treat (ITT) Population consisted of all participants who were randomized and to whom study drug was dispensed.
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| ID | Title | Description |
|---|---|---|
| BG000 | CD2475/101 40 mg | Participants received 40 mg of CD2475/101 oral tablet plus placebo capsule orally once daily for 16 weeks. |
| BG001 | Doxycycline 100 mg | Participants received 100 mg of Doxycycline capsule plus placebo tablet orally once daily for 16 weeks. |
| BG002 | Placebo | Participants received matching placebo tablet plus placebo capsule orally once daily for 16 weeks. |
| BG003 | Total | Total of all reporting groups |
| 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 | Participants |
| ||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
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| 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 | Change From Baseline in Inflammatory Lesion Counts to Week 16 (Last Observation Carried Forward [LOCF]) | The Inflammatory lesion count was the count of papules and pustules: papule was a small, solid elevation less than 0.5 cm in diameter, pustule was a small, circumscribed elevation of the skin that contains yellow-white exudate. Change from baseline in inflammatory lesion counts to Week 16 (LOCF) were reported. | Intent To Treat (ITT) population consisted of all participants who were randomized and to whom study drug was dispensed. | Posted | Mean | Standard Deviation | lesion count | From Baseline up to Week 16 (LOCF) |
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| Secondary | Investigator Global Assessment (IGA) Success Rate at Week 16 (Last Observation Carried Forward [LOCF]) | IGA scale consisted of 5 grades (0-4) among which 0= Clear (no evidence of papules or pustules [inflammatory lesions]), 1= Almost clear (rare non-inflamed papules (papules must be resolving and hyperpigmented, though not pink-red), 2= Mild (few inflammatory lesions [papules/pustules only; no nodulo-cystic lesions]), 3=Moderate (multiple inflammatory lesions evident: many papules/pustules; up to two nodulocystic lesions), 4= Severe (inflammatory lesions are more apparent, many papules/pustules, few nodulo-cystic lesions). Success rate was defined as percentage of participants who achieved an Investigator Global Assessment (IGA) score of 1 (almost clear) or 0 (Clear) and at least a 2-grade improvement from Baseline to Week 16 (LOCF). | ITT Population consisted of all participants who were randomized and to whom study drug was dispensed. | Posted | Number | Percentage of participants | Week 16 (LOCF) |
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| Secondary | Percent Change From Baseline in Inflammatory Lesion Counts to Week 16 (Last Observation Carried Forward [LOCF]) | The Inflammatory lesion count was the count of papules and pustules: papule was a small, solid elevation less than 0.5 cm in diameter, pustule was a small, circumscribed elevation of the skin that contains yellow-white exudate. Percent change from baseline in inflammatory lesion counts to Week 16 (LOCF) were reported. | ITT population consisted of all participants who were randomized and to whom study drug was dispensed. | Posted | Mean | Standard Deviation | percent change | From Baseline up to Week 16 (LOCF) |
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| Secondary | Percent Change From Baseline in Total Lesion Counts to Week 16 (Last Observation Carried Forward [LOCF]) | Total lesions were the sum of inflammatory lesion counts, non-inflammatory lesion counts, nodules and cysts. Percentage change from baseline in total lesion counts to Week 16 were reported. | ITT population consisted of all participants who were randomized and to whom study drug was dispensed. | Posted | Mean | Standard Deviation | percent change | From Baseline up to Week 16 (LOCF) |
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| Secondary | Change From Baseline in Non-Inflammatory Lesion Counts to Week 16 (Last Observation Carried Forward [LOCF]) | The non-inflammatory lesion count was the count of open and closed comedones: Open comedone was a pigmented dilated pilosebaceous orifice (blackhead). Closed comedone was a tiny white papule (whitehead). Change from baseline in non-inflammatory lesion counts to week 16 were reported | ITT population consisted of all participants who were randomized and to whom study drug was dispensed. | Posted | Mean | Standard Deviation | lesion count | From Baseline up to Week 16 (LOCF) |
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| Secondary | Global Assessment for Inflammatory Lesions of Truncal Acne at Baseline, Week 12, and Week 16 | Global assessments for inflammatory lesions of truncal acne were done separately on back and chest. The global assessments severity scale included 5 grades (0-4): where in 0= Clear-no evidence of papules or pustules (inflammatory lesions), 1= Almost clear- rare non-inflamed papules (papules must be resolving and may be hyperpigmented, though not pink-red), 2=Mild- few inflammatory lesions (papules/pustules only; no nodulo-cystic lesions), 3=Moderate- multiple inflammatory lesions evident: many papules/pustules; may be a few nodulocystic lesions, 4=Severe- inflammatory lesions are more apparent, many papules/pustules, may be a few nodulo-cystic lesions. | ITT population consisted of all participants who were randomized and to whom study drug was dispensed. | Posted | Mean | Standard Deviation | Units on a scale | Baseline, Week 12, and Week 16 |
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| Secondary | Number of Participants With at Least One Adverse Event (AE) | An AE was any untoward medical occurrence in a participant or clinical investigation participants administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. Number of participants with at least one AE were reported. | Safety Population consisted of all participants who received at least one dose of study drug. | Posted | Count of Participants | Participants | From Baseline up to Week 16 |
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|
From Baseline up to Week 16
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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 | CD2475/101 40 mg | Participants received 40 mg of CD2475/101 oral tablet plus placebo capsule orally once daily for 16 weeks. | 0 | 216 | 1 | 216 | 29 | 216 |
| EG001 | Doxycycline 100 mg | Participants received 100 mg of Doxycycline capsule plus placebo tablet orally once daily for 16 weeks. | 0 | 223 | 4 | 223 | 51 | 223 |
| EG002 | Placebo | Participants received 100 mg of Doxycycline capsule plus placebo tablet orally once daily for 16 weeks. | 0 | 222 | 2 | 222 | 29 | 222 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Affective disorder | Psychiatric disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Suicide attempt | Psychiatric disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Coagulopathy | Blood and lymphatic system disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Forearm fracture | Injury, poisoning and procedural complications | MedDRA (13.0) | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA (13.0) | Non-systematic Assessment |
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| Multiple drug overdose intentional | Injury, poisoning and procedural complications | MedDRA (13.0) | Non-systematic Assessment |
| |
| Uterine leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (13.0) | Non-systematic Assessment |
| |
| Multiple sclerosis relapse | Nervous system disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Hepatic encephalopathy | Nervous system disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA (13.0) | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (13.0) | Non-systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Operations | Galderma | 817 961 5000 | +1 | Clinical.Studies@galderma.com |
| 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 |
|---|---|
| D004318 | Doxycycline |
| ID | Term |
|---|---|
| D013754 | Tetracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
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| Between 18 and 65 years |
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| >=65 years |
|
| Male |
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| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Mean Difference (Final Values) |
| -2.9 |
| 2-Sided |
| 95 |
| -5.4 |
| -0.4 |
| Superiority |
| ANCOVA | 0.595 | Mean Difference (Final Values) | -0.7 | 2-Sided | 95 | -3.2 | 1.8 | Superiority |
Participants received matching placebo tablet plus placebo capsule orally once daily for 16 weeks. |
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| Units | Counts |
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| Participants |
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| Participants |
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| Units |
|---|
| Counts |
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| Participants |
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Participants received matching placebo tablet plus placebo capsule orally once daily for 16 weeks.
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| Participants |
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