A Double Blinded, Prospective, Randomized, Vehicle Contro... | NCT01347879

Status Module

Label	Type	Description	Intervention Names
Visonac cream with PDT	Experimental	active treatment with light dose of 37 Joule/cm2	Drug: Visonac PDT
Vehicle cream with PDT	Placebo Comparator	Placebo treatment, Light dose 37 Joule/cm2	Drug: Vehicle cream with PDT

Name	Type	Description	Arm Group Labels	Other Names
Visonac PDT	Drug	cream application prior to illumination with red light	Visonac cream with PDT

Measure	Description	Time Frame
Absolute Change From Baseline in Facial Inflammatory Lesion Count (Nodules, Papules, and Pustules).		From baseline to 12 weeks after first treatment

Measure	Description	Time Frame
Absolute Change From Baseline in Facial Non-inflammatory Lesion Count (Open and Closed Comedones)		From baseline to 12 weeks after the first treatment
Percent Change From Baseline in Facial Inflammatory (Nodules, Papules, and Pustules)Lesion Counts.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Female and male patients, from 12-35 years of age with severe facial acne vulgaris (IGA score 4 on IGA scale)
Signed and verified informed consent form and photo consent form. For subjects under age of 18, an assent form in conjunction with an informed consent form, signed and verified by parent/guardian.
Female patients who are surgically sterile, pre-menstrual, postmenopausal, abstinent, or willing to use an adequate means of contraception including birth control pills, or barrier methods and spermicide for at least 14 days prior to T1. Patients using birth control pills must have used the same product and dose for at least 3 months and must agree to stay with the same product and dose for an additional 3 months.
Fitzpatrick skin type I through VI,
Patients with 25 to 75 inflammatory lesions (papules, pustules, and nodules) on the face.
Patients with 20 to 100 non-inflammatory lesions (open and closed comedones) on the face.

Exclusion Criteria:

Patients with acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne, etc.)
Patients with more than 3 nodules on the face.
Patient is the investigator or any sub investigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the study.
Patients unlikely to comply with the protocol, e.g. mental condition rendering the patient unable to understand the nature, scope, and possible consequences of the clinical study, uncooperative attitude or unlikelihood of completing the study (e.g. drug or alcohol abuse).
Female patients with childbearing potential (i.e. ovulation, pre-menopausal, not surgically sterilized) and sexually active, not willing to use a medically accepted contraceptive regimen (as described under inclusion criteria) while on treatment.
Pregnancy.
Nursing.
Participation in other clinical studies either currently or within the last 30 days.
Patients with porphyria.
Patients with cutaneous photosensitivity.
Known allergy to MAL, to a similar PDT compound, or to excipients of the cream
Patients using testosterone, any other systemic hormonal treatment or hormonal contraceptives solely for control of acne.
Patients who have received topical treatments for their facial acne within the last 14 days (e.g steroids, retinoids, glycolic acid, benzoyl peroxide, anti inflammatory agents, antibiotics). Medicated cleansers may be used during the washout period and stopped before the treatment.
Patients who have received oral antibiotics for treatment of their acne within the last month.
Patients who have received oral isotretinoin within the last 6 months.
Patient who have received facial procedures like dermabrasion, chemical or laser peels within the last 1 month.
Patients using testosterone, any systemic hormonal treatment for other reasons than acne treatment and has not been on the same product and dose for at least 3 months
Patients with moderate, severe or very severe facial acne scarring according to scarring scale described in section 10.4.3.
Patients with a beard that might interfere with study assessments.
Patients with melanoma or dysplastic nevi in the treatment area.
Exposure to ultraviolet radiation (UVB phototherapy, sun tanning salons) within the last 30 days
Exposure to PDT within 12 weeks before T1.

Name	Affiliation	Role
David Pariser, MD	Virginia Clinical Research, Inc.	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Dermatology Specialists Inc		Oceanside	California	92056	United States
Rady Children's Hospital

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Vehicle Cream With PDT	Placebo treatment, Light dose 37 J/cm2 Visonac PDT : cream application prior to illumination with red light
FG001	Visonac Cream With PDT	active treatment with light dose of 37 J/cm2 Visonac photodynamic therapy (PDT): cream application prior to illumination with red light

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

ID	Title	Description
BG000	Vehicle Cream With PDT	Placebo treatment, Light dose 37 J/cm2 Visonac PDT : cream application prior to illumination with red light
BG001	Visonac Cream With PDT	active treatment with light dose of 37J/cm2 Visonac PDT : cream application prior to illumination with red light
BG002	Total	Total of all reporting groups

Units	Counts
Participants	BG00053 BG001100 BG002153

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Categorical

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
<=18 years	BG00035 BG00159 BG00294
Between 18 and 65 years

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00018.6± 5.8 BG00118.6± 5.5 BG002

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00022 BG00144 BG002

Region of Enrollment

Number

participants

Title

Denominators

Categories

United States

Title	Measurements
	BG00053 BG001100 BG002

Skin type

Fitzpatrick skin type. The Fitzpatrick Scale:

Type I (scores 0-7) Light, pale white. Always burns, never tans

Type II (scores 8-16) White; fair. Usually burns, tans with difficulty

Type III (scores 17-24) Medium, white to olive. Sometimes mild burn, gradually tans to olive.

Type IV (scores 25-30) Olive, moderate brown. Rarely burns, tans with ease to a moderate brown.

Type V (scores over 30) Brown, dark brown. Very rarely burns, tans very easily

Type VI Black, very dark brown to black. Never burns, tans very easily, deeply pigmented.

Number

participants

Title

Denominators

Categories

Skin type I

Title	Measurements
	BG0000 BG001

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

Absolute Change From Baseline in Facial Inflammatory Lesion Count (Nodules, Papules, and Pustules).

Posted

Mean

Standard Deviation

lesion count

From baseline to 12 weeks after first treatment

ID	Title	Description
OG000	Vehicle Cream With PDT	Placebo treatment, Light dose 37 J/cm2 Visonac PDT : cream application prior to illumination with red light
OG001	Visonac Cream With PDT	active treatment with light dose of 37J/cm2 Visonac PDT : cream application prior to illumination with red light

Units	Counts
Participants	OG00053 OG001100

Title

Denominators

Categories

Title	Measurements
	OG000-7.8± 21.4 OG001-15.6± 16.4

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		ANCOVA	Lesion count at baseline and center as covariates	0.006		Difference in least square means	-7.35			2-Sided	95	-12.5	-2.2				No	Superiority or Other

Secondary

Absolute Change From Baseline in Facial Non-inflammatory Lesion Count (Open and Closed Comedones)

Posted

Mean

Standard Deviation

lesion count

From baseline to 12 weeks after the first treatment

ID	Title	Description
OG000	Vehicle Cream With PDT	Placebo treatment, Light dose 37 J/cm2 Visonac PDT : cream application prior to illumination with red light
OG001	Visonac Cream With PDT	active treatment with light dose of 37J/cm2 Visonac PDT : cream application prior to illumination with red light

Units	Counts
Participants	OG000

Secondary

Percent Change From Baseline in Facial Inflammatory (Nodules, Papules, and Pustules)Lesion Counts.

Posted

Median

Full Range

percent change

From baseline to 12 weeks after the first treatment

ID	Title	Description
OG000	Vehicle Cream With PDT	Placebo treatment, Light dose 37 J/cm2 Visonac PDT : cream application prior to illumination with red light
OG001	Visonac Cream With PDT	active treatment with light dose of 37J/cm2 Visonac PDT : cream application prior to illumination with red light

Units	Counts
Participants	OG000

Secondary

Proportion of Patients With Success According to IGA Scale Based on the Facial Assessment.

One Investigator Global Assessment (IGA) scale was used including inflammatory and non-inflammatory lesions. The investigator qualitatively graded the overall acne severity on a scale from 0 to 4, with 4 being the most severe. Success was defined as an improvement of at least 2 grades from the baseline score.

Posted

Number

participants

From baseline to 12 weeks after first treatment

ID	Title	Description
OG000	Vehicle Cream With PDT	Placebo treatment, Light dose 37 J/cm2 Visonac PDT : cream application prior to illumination with red light
OG001	Visonac Cream With PDT	active treatment with light dose of 37J/cm2 Visonac PDT : cream application prior to illumination with red light

Units	Counts
Participants	OG000

Secondary

Pain During Illumination.

Pain during illumination was assessed by patient using a Visual Analogue Scale (VAS) from 0 to 10, where 0 indicates no pain and 10 indicates the worst pain imaginable.

Posted

Mean

Full Range

VAS score in cm

Immediately after first treatment

ID	Title	Description
OG000	Vehicle Cream With PDT	Placebo treatment, Light dose 37 J/cm2 Visonac PDT : cream application prior to illumination with red light
OG001	Visonac Cream With PDT	active treatment with light dose of 37J/cm2 Visonac PDT : cream application prior to illumination with red light

Units	Counts
Participants	OG000

Secondary

Number of Patients With Adverse Events.

Posted

Number

participants

From administration of investigational medicinal product (IMP) until 12 weeks after first IMP administration

ID	Title	Description
OG000	Vehicle Cream With PDT	Placebo treatment, Light dose 37 J/cm2 Visonac PDT : cream application prior to illumination with red light
OG001	Visonac Cream With PDT	active treatment with light dose of 37J/cm2 Visonac PDT : cream application prior to illumination with red light

Units	Counts
Participants	OG000

Secondary

Erythema Score of Mild and Moderate

Clinical assessment using a 4 point scale; none, mild, moderate, severe

Posted

Number

participants

Immediately after first treatment

ID	Title	Description
OG000	Vehicle Cream With PDT	Placebo treatment, Light dose 37 J/cm2 Visonac PDT : cream application prior to illumination with red light
OG001	Visonac Cream With PDT	active treatment with light dose of 37J/cm2 Visonac PDT : cream application prior to illumination with red light

Units	Counts
Participants	OG000

Secondary

Clear and Almost Clear Scarring According to Scarring Score

Clinical assessment using a 6 point scale; Clear, Almost clear, Mild, Moderate, Severe and Very severe

100 patients were included and 83 patients completed the study in the Visonac treatment arm. However, a few patients came back for the week 12 visit only, and have data for scarring. The total number of patients with scarring data at 12 weeks in this group is 91.

Posted

Number

participants

at week 12 after first treatment

ID	Title	Description
OG000	Vehicle Cream With PDT	Placebo treatment, Light dose 37 J/cm2 Visonac PDT : cream application prior to illumination with red light
OG001	Visonac Cream With PDT	active treatment with light dose of 37J/cm2 Visonac PDT : cream application prior to illumination with red light

Units	Counts
Participants	OG000

Secondary

Percent Change From Baseline in Facial Non-inflammatory Lesion Count (Open and Closed Comedones)

Posted

Median

Full Range

percent change

From baseline to 12 weeks after first treatment

ID	Title	Description
OG000	Vehicle Cream With PDT	Placebo treatment, Light dose 37 J/cm2 Visonac PDT : cream application prior to illumination with red light
OG001	Visonac Cream With PDT	active treatment with light dose of 37J/cm2 Visonac PDT : cream application prior to illumination with red light

Units	Counts
Participants	OG000

Secondary

Erythema Score of Severe

Clinical assessment using a 4 point scale; none, mild, moderate, severe

Posted

Number

participants

Immediately after first treatment

ID	Title	Description
OG000	Vehicle Cream With PDT	Placebo treatment, Light dose 37 J/cm2 Visonac PDT : cream application prior to illumination with red light
OG001	Visonac Cream With PDT	active treatment with light dose of 37J/cm2 Visonac PDT : cream application prior to illumination with red light

Units	Counts
Participants	OG000

Secondary

Erythema Score of Mild and Moderate

Clinical assessment using a 4 point scale; none, mild, moderate, severe

Of the 100 patients who were included in the Visonac treatment arm, 5 dropped out prior to the day 2 erythema assessment. The number of patients with erythema data at this assessment point is 95.

Posted

Number

participants

2 days after first treatment

ID	Title	Description
OG000	Vehicle Cream With PDT	Placebo treatment, Light dose 37 J/cm2 Visonac PDT : cream application prior to illumination with red light
OG001	Visonac Cream With PDT	active treatment with light dose of 37J/cm2 Visonac PDT : cream application prior to illumination with red light

Units	Counts
Participants	OG000

Secondary

Erythema Score of Severe

Clinical assessment using a 4 point scale; none, mild, moderate, severe

Of the 100 patients who were included in the Visonac treatment arm, 5 dropped out prior to the day 2 erythema assessment. The number of patients with erythema data at this assessment point is 95.

Posted

Number

participants

2 days after first treatment

ID	Title	Description
OG000	Vehicle Cream With PDT	Placebo treatment, Light dose 37 J/cm2 Visonac PDT : cream application prior to illumination with red light
OG001	Visonac Cream With PDT	active treatment with light dose of 37J/cm2 Visonac PDT : cream application prior to illumination with red light

Units	Counts
Participants	OG000

Secondary

Mild and Moderate Scarring According to Scarring Score

Clinical assessment using a 6 point scale; Clear, Almost clear, Mild, Moderate, Severe and Very severe

Posted

Number

participants

at week 12 after first treatment

ID	Title	Description
OG000	Vehicle Cream With PDT	Placebo treatment, Light dose 37 J/cm2 Visonac PDT : cream application prior to illumination with red light
OG001	Visonac Cream With PDT	active treatment with light dose of 37J/cm2 Visonac PDT : cream application prior to illumination with red light

Units	Counts
Participants	OG000

Secondary

Severe and Very Severe Scarring According to Scarring Score

Clinical assessment using a 6 point scale; Clear, Almost clear, Mild, Moderate, Severe and Very severe

Posted

Number

participants

at week 12 after first treatment

ID	Title	Description
OG000	Vehicle Cream With PDT	Placebo treatment, Light dose 37 J/cm2 Visonac PDT : cream application prior to illumination with red light
OG001	Visonac Cream With PDT	active treatment with light dose of 37J/cm2 Visonac PDT : cream application prior to illumination with red light

Units	Counts
Participants	OG000

Other Adverse Events

Term	Organ System	Statistical Information
Pain of skin	Skin and subcutaneous tissue disorders	EG0000 affected53 at risk EG00117 affected100 at risk
Skin burning sensation	Skin and subcutaneous tissue disorders	EG0000 affected53 at risk EG00115 affected100 at risk
Pruritus	Skin and subcutaneous tissue disorders	EG0001 affected53 at risk EG0018 affected100 at risk
Erythema	Skin and subcutaneous tissue disorders	EG0000 affected53 at risk EG0014 affected100 at risk
Rash	Skin and subcutaneous tissue disorders	EG0001 affected53 at risk EG0012 affected100 at risk
Scab	Skin and subcutaneous tissue disorders	EG0000 affected53 at risk EG0012 affected100 at risk
Headache	Nervous system disorders	EG0003 affected53 at risk EG0013 affected100 at risk
Nasal congestion	Respiratory, thoracic and mediastinal disorders	EG0002 affected53 at risk EG0010 affected100 at risk
Swelling face	Skin and subcutaneous tissue disorders	EG0001 affected53 at risk EG0011 affected100 at risk
Dermatitis	Skin and subcutaneous tissue disorders	EG0001 affected53 at risk EG0010 affected100 at risk
Conjunctivitis bacterial	Eye disorders	EG0000 affected53 at risk EG0011 affected100 at risk
Staphylococcal infection	Infections and infestations	EG0001 affected53 at risk EG0010 affected100 at risk
Tooth abscess	General disorders	EG0001 affected53 at risk EG0010 affected100 at risk
Cough	Respiratory, thoracic and mediastinal disorders	EG0001 affected53 at risk EG0010 affected100 at risk
Concussion	Injury, poisoning and procedural complications	EG0001 affected53 at risk EG0011 affected100 at risk
Skin hyperpigmentation	Skin and subcutaneous tissue disorders	EG0000 affected53 at risk EG0012 affected100 at risk
Blister	Skin and subcutaneous tissue disorders	EG0000 affected53 at risk EG0011 affected100 at risk
Gastroenteritis	Infections and infestations	EG0000 affected53 at risk EG0012 affected100 at risk
Nasopharyngitis	Infections and infestations	EG0000 affected53 at risk EG0012 affected100 at risk
Nausea	Gastrointestinal disorders	EG0000 affected53 at risk EG0013 affected100 at risk
Vomiting	General disorders	EG0000 affected53 at risk EG0012 affected100 at risk
Back pain	Musculoskeletal and connective tissue disorders	EG0000 affected53 at risk EG0012 affected100 at risk
Pyrexia	General disorders	EG0000 affected53 at risk EG0012 affected100 at risk
Cough	Respiratory, thoracic and mediastinal disorders	EG0001 affected53 at risk EG0011 affected100 at risk
Joint sprain	Injury, poisoning and procedural complications	EG0000 affected53 at risk EG0012 affected100 at risk

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

ID	Term
D000095742	Red Light
C008848	1-phenyl-3,3-dimethyltriazene

ID	Term
D008027	Light
D060733	Electromagnetic Radiation
D055590	Electromagnetic Phenomena
D060328	Magnetic Phenomena
D055585	Physical Phenomena
D055620	Optical Phenomena
D011827	Radiation
D011840	Radiation, Nonionizing

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Vehicle Cream With PDT	Placebo treatment, Light dose 37 J/cm2 Visonac PDT : cream application prior to illumination with red light			0	53	14	53
EG001	Visonac Cream With PDT	active treatment with light dose of 37J/cm2 Visonac PDT : cream application prior to illumination with red light			0	100	48	100