A Phase 2 Dose Escalating Study to Evaluate the Safety an... | NCT01631474

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Low-dose active, BID	Experimental	low dose of CB-03-01, 0.1% applied twice a day	Drug: CB-03-01
Medium-dose active, BID	Experimental	medium dose of CB-03-01, 0.5% applied twice a day	Drug: CB-03-01
High-dose active, QD	Experimental	high dose of CB-03-01, 1% applied once a day	Drug: CB-03-01
High-dose active, BID	Experimental	high dose of CB-03-01, 1% applied twice a day	Drug: CB-03-01
Vehicle, QD or BID	Placebo Comparator	vehicle cream, applied once or twice a day	Drug: Vehicle

Name	Type	Description	Arm Group Labels	Other Names
CB-03-01	Drug	Topical cream, applied once a day	High-dose active, QD

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Investigator's Global Assessment (IGA) "Success" - Week 12	Count and percentage of subjects achieving success in each treatment group at Week 12 using the dichotomized IGA with success defined as a score of "clear" or "almost clear" (IGA Score of 0 or 1) and a two or more grade improvement from Baseline using a five-point scale (0=clear to 4=severe).	Baseline and Week 12
Inflammatory and Non-Inflammatory Lesion Counts - Week 12	Absolute change from Baseline in inflammatory and non-inflammatory lesion counts in each treatment group at Week 12.	Baseline and Week 12

Secondary Outcomes

Measure	Description	Time Frame
Inflammatory and Non-Inflammatory Lesion Counts - Week 8	Absolute change from Baseline in inflammatory and non-inflammatory lesion counts in each treatment group at Week 8.	Baseline and Week 8
Percent Change in Lesion Counts - Weeks 8 and 12

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subject is male or non-pregnant female. Females must be post-menopausal, surgically sterile or using highly effective birth control methods.
Subject has provided written and verbal informed consent/assent.
Subject has facial acne vulgaris (including the nose).
Subject is willing to comply with study instructions and return to the clinic for required visits.
Subject has used the same type and brand of make-up, other facial products (including cleanser) and hair products (e.g., shampoo, gel, hair spray, mousse, etc.) for at least one month prior to the study start and agrees to continue his/her other general skin and hair care products and regimen for the entire study.

Exclusion Criteria:

Subject is pregnant, lactating, or is planning to become pregnant during the study.
Subject is currently enrolled in an investigational drug or device study.
Subject has received an investigational drug or been treated with an investigational device within 30 days prior to the study start.
Subject has the need or plans to be exposed to artificial tanning devices or excessive sunlight during the trial
Subject has used any of the following topical anti-acne preparations or procedures on the face:
- Topical anti-acne treatments including but not limited to over-the-counter acne cleaners or treatments, benzoyl peroxide, antibiotics, azelaic acid, sulfa based products, corticosteroids and salicylic acid within two weeks of the initiation of treatment.
- Retinoids, including tazarotene, adapalene, tretinoin, within four weeks of the initiation of treatment.
- Light treatments, microdermabrasion or chemical peels within eight weeks of the initiation of treatment.
Subject has used the following systemic anti-acne medications:
- Corticosteroids (including intramuscular and intralesional injections) within four weeks of the initiation of treatment. Inhaled, intranasal or ocular corticosteroids are allowed if use is stable (stable use is defined as dose and frequency unchanged for at least four weeks prior to the initiation of treatment).
- Antibiotics within four weeks of the initiation of treatment with the exception of five days or less of antibiotic therapy during this period, but with no antibiotics use permitted within one week prior to the initiation of treatment.
- Spironolactone within eight weeks of the initiation of treatment with the exception of five days or less of spironolactone therapy during this period, but with no spironolactone use permitted within one week prior to the initiation of treatment.
- Retinoid therapy within six months of the initiation of treatment.

Name	Affiliation	Role
R&D Cassiopea	Cassiopea S.p.A.	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Dermatology Research Associates		Los Angeles	California	90045	United States
Therapeutics Clinical Research

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Low-dose Active, BID	low dose of CB-03-01, 0.1% applied twice a day CB-03-01: Topical cream, applied twice a day
FG001	Medium-dose Active, BID	medium dose of CB-03-01, 0.5% applied twice a day CB-03-01: Topical cream, applied twice a day

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Arm/Group Information

ID	Title	Description
BG000	Low-dose Active, BID	low dose of CB-03-01, 0.1% applied twice a day CB-03-01: Topical cream, applied twice a day
BG001	Medium-dose Active, BID	medium dose of CB-03-01, 0.5% applied twice a day CB-03-01: Topical cream, applied twice a day
BG002	High-dose Active, QD	high dose of CB-03-01, 1% applied once a day CB-03-01: Topical cream, applied once a day
BG003	High-dose Active, BID	high dose of CB-03-01, 1% applied twice a day CB-03-01: Topical cream, applied twice a day
BG004	Vehicle, QD or BID	vehicle cream, applied once or twice a day Vehicle: Topical cream, applied once or twice a day
BG005	Total	Total of all reporting groups

Units	Counts
Participants	BG00072 BG00176 BG00270 BG00370 BG00475 BG005363

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00019.8± 5.77 BG00120.4± 6.31 BG00218.3± 6.14 BG003

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00036 BG00142 BG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG00022 BG00120 BG002

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0000 BG0011 BG002

Baseline IGA

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
0 - Clear	BG0000 BG0010 BG002

Baseline lesions counts

Mean

Full Range

lesions

Title

Denominators

Categories

Inflammatory lesions

Title	Measurements
	BG00029.9(20 to 74) BG00129.0(20 to 74) BG002

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

Investigator's Global Assessment (IGA) "Success" - Week 12

Count and percentage of subjects achieving success in each treatment group at Week 12 using the dichotomized IGA with success defined as a score of "clear" or "almost clear" (IGA Score of 0 or 1) and a two or more grade improvement from Baseline using a five-point scale (0=clear to 4=severe).

Per-Protocol Population, defined as a subset of the ITT population and included those subjects that met eligibility criteria, completed the end-of-study visit, and applied at least 80% of the expected treatment applications.

Posted

Count of Participants

Participants

Baseline and Week 12

ID	Title	Description
OG000	Low-dose Active, BID	low dose of CB-03-01, 0.1% applied twice a day CB-03-01: Topical cream, applied twice a day
OG001	Medium-dose Active, BID	medium dose of CB-03-01, 0.5% applied twice a day CB-03-01: Topical cream, applied twice a day
OG002	High-dose Active, QD	high dose of CB-03-01, 1% applied once a day CB-03-01: Topical cream, applied once a day
OG003	High-dose Active, BID	high dose of CB-03-01, 1% applied twice a day CB-03-01: Topical cream, applied twice a day
OG004	Vehicle, QD or BID	vehicle cream, applied once or twice a day Vehicle: Topical cream, applied once or twice a day

Units	Counts
Participants	OG00057 OG00164 OG00252 OG003

Title

Denominators

Categories

Title	Measurements
	OG0005 OG0013 OG0022 OG003

Primary

Inflammatory and Non-Inflammatory Lesion Counts - Week 12

Absolute change from Baseline in inflammatory and non-inflammatory lesion counts in each treatment group at Week 12.

Per protocol population.

Posted

Mean

Standard Deviation

lesions

Baseline and Week 12

ID	Title	Description
OG000	Low-dose Active, BID	low dose of CB-03-01, 0.1% applied twice a day CB-03-01: Topical cream, applied twice a day
OG001	Medium-dose Active, BID	medium dose of CB-03-01, 0.5% applied twice a day CB-03-01: Topical cream, applied twice a day
OG002	High-dose Active, QD	high dose of CB-03-01, 1% applied once a day CB-03-01: Topical cream, applied once a day
OG003	High-dose Active, BID	high dose of CB-03-01, 1% applied twice a day CB-03-01: Topical cream, applied twice a day
OG004	Vehicle, QD or BID

Secondary

Inflammatory and Non-Inflammatory Lesion Counts - Week 8

Absolute change from Baseline in inflammatory and non-inflammatory lesion counts in each treatment group at Week 8.

Per protocol population

Posted

Mean

Standard Deviation

lesions

Baseline and Week 8

ID	Title	Description
OG000	Low-dose Active, BID	low dose of CB-03-01, 0.1% applied twice a day CB-03-01: Topical cream, applied twice a day
OG001	Medium-dose Active, BID	medium dose of CB-03-01, 0.5% applied twice a day CB-03-01: Topical cream, applied twice a day
OG002	High-dose Active, QD	high dose of CB-03-01, 1% applied once a day CB-03-01: Topical cream, applied once a day
OG003	High-dose Active, BID	high dose of CB-03-01, 1% applied twice a day CB-03-01: Topical cream, applied twice a day
OG004	Vehicle, QD or BID

Secondary

Percent Change in Lesion Counts - Weeks 8 and 12

Percent change from Baseline in lesion counts (inflammatory and noninflammatory) in each treatment group at Weeks 8 and 12.

Per protocol population

Posted

Mean

Standard Deviation

percentage of change

Week 8 and Week 12

ID	Title	Description
OG000	Low-dose Active, BID	low dose of CB-03-01, 0.1% applied twice a day CB-03-01: Topical cream, applied twice a day
OG001	Medium-dose Active, BID	medium dose of CB-03-01, 0.5% applied twice a day CB-03-01: Topical cream, applied twice a day
OG002	High-dose Active, QD	high dose of CB-03-01, 1% applied once a day CB-03-01: Topical cream, applied once a day
OG003	High-dose Active, BID	high dose of CB-03-01, 1% applied twice a day CB-03-01: Topical cream, applied twice a day
OG004

Secondary

IGA "Success" - Week 8

Count and percentage of subjects achieving success per the IGA in each treatment group at Week 8 ("success" as defined in the primary endpoints section).

Per protocol population.

Posted

Count of Participants

Participants

Baseline and Week 8

ID	Title	Description
OG000	Low-dose Active, BID	low dose of CB-03-01, 0.1% applied twice a day CB-03-01: Topical cream, applied twice a day
OG001	Medium-dose Active, BID	medium dose of CB-03-01, 0.5% applied twice a day CB-03-01: Topical cream, applied twice a day
OG002	High-dose Active, QD	high dose of CB-03-01, 1% applied once a day CB-03-01: Topical cream, applied once a day
OG003	High-dose Active, BID	high dose of CB-03-01, 1% applied twice a day CB-03-01: Topical cream, applied twice a day
OG004

Secondary

IGA "Clear" or "Almost Clear" - Weeks 4, 8 and 12

Count and percentage of subjects who are "clear" or "almost clear" (IGA Grade 0 or 1) in each treatment group at Weeks 4, 8 and 12.

Per protocol population.

Posted

Count of Participants

Participants

Weeks 4, 8, and 12

ID	Title	Description
OG000	Low-dose Active, BID	low dose of CB-03-01, 0.1% applied twice a day CB-03-01: Topical cream, applied twice a day
OG001	Medium-dose Active, BID	medium dose of CB-03-01, 0.5% applied twice a day CB-03-01: Topical cream, applied twice a day
OG002	High-dose Active, QD	high dose of CB-03-01, 1% applied once a day CB-03-01: Topical cream, applied once a day
OG003	High-dose Active, BID	high dose of CB-03-01, 1% applied twice a day CB-03-01: Topical cream, applied twice a day
OG004

Arm/Groups

ID	Title	Description	Deaths (At Risk)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Low-dose Active, BID	low dose of CB-03-01, 0.1% applied twice a day CB-03-01: Topical cream, applied twice a day	72	72	12	72
EG001	Medium-dose Active, BID	medium dose of CB-03-01, 0.5% applied twice a day CB-03-01: Topical cream, applied twice a day	76	76	18	76
EG002	High-dose Active, QD	high dose of CB-03-01, 1% applied once a day CB-03-01: Topical cream, applied once a day	70	70	9	70
EG003	High-dose Active, BID	high dose of CB-03-01, 1% applied twice a day CB-03-01: Topical cream, applied twice a day	70	70	5	70
EG004	Vehicle, QD or BID	vehicle cream, applied once or twice a day Vehicle: Topical cream, applied once or twice a day	75	75	5	75

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Upper respiratory tract infection	Infections and infestations	MedDRA (16.0)	Systematic Assessment	EG0006 events6 affected72 at risk EG0018 events8 affected76 at risk EG0022 events2 affected70 at risk EG0033 events3 affected70 at risk EG004
Nasopharyngitis	Infections and infestations	MedDRA (16.0)	Systematic Assessment	EG0001 events1 affected72 at risk EG0010 events0 affected76 at risk EG0024 events4 affected70 at risk EG003
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA (16.0)	Systematic Assessment	EG0001 events1 affected72 at risk EG0014 events4 affected76 at risk EG0021 events1 affected70 at risk EG003
Headache	Nervous system disorders	MedDRA (16.0)	Systematic Assessment	EG0002 events2 affected72 at risk EG0011 events1 affected76 at risk EG0020 events0 affected70 at risk EG003
Pyrexia	General disorders	MedDRA (16.0)	Systematic Assessment	EG0000 events0 affected72 at risk EG0012 events2 affected76 at risk EG0022 events2 affected70 at risk EG003
Nasal congestion	Respiratory, thoracic and mediastinal disorders	MedDRA (16.0)	Systematic Assessment	EG0000 events0 affected72 at risk EG0012 events2 affected76 at risk EG0020 events0 affected70 at risk EG003
Laceration	Injury, poisoning and procedural complications	MedDRA (16.0)	Systematic Assessment	EG0002 events2 affected72 at risk EG0011 events1 affected76 at risk EG0020 events0 affected70 at risk EG003

ID	Term
D017486	Acneiform Eruptions
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases
D012625	Sebaceous Gland Diseases