Photodynamic Therapy (PDT) With Methyl Aminolevulinate (M... | NCT00594425

Status Module

Oversight Module

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	PDT using MAL concentration A	Drug: Methyl aminolevulinate (MAL) PDT
2	Experimental	PDT using MAL concentration B	Drug: Methyl aminolevulinate (MAL) PDT
3	Placebo Comparator	PDT using Placebo cream	Drug: Methyl aminolevulinate (MAL) PDT

Name	Type	Description	Arm Group Labels	Other Names
Methyl aminolevulinate (MAL) PDT	Drug	Cream application followed by illumination with red light	1 2 3

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Proportion of Success, Defined as Improvement of at Least 2 Grades From Baseline According to the IGA Scale Based on Facial Assessment		12 weeks after last treatment
Change in Facial Inflammatory (Nodules, Papules, and Pustules) Lesion Counts		12 weeks after last treatment
Change in Facial Inflammatory (Nodules, Papules, and Pustules) Lesion Counts From Baseline		12 weeks

Secondary Outcomes

Measure	Description	Time Frame
Median Percentage Change in Facial Inflammatory (Nodules, Papules, and Pustules) Lesion Counts From Baseline		3 weeks after last treatment
Median Percentage Change in Facial Inflammatory (Nodules, Papules, and Pustules) Lesion Counts From Baseline		6 weeks after last treatment

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Female and male patients, age 15 to 40 years with moderate to severe facial acne vulgaris (IGA score 3-4).
Patients with skin type I to IV (Fitzpatrick).
Patients with 20 to 100 inflammatory lesions (papules, pustules, and nodules) on the face excluding lesions on the nose and in the peri-ocular area.
Patients with up to 200 noninflammatory lesions (open and closed comedones) on the face.
Patients with no more than 2 nodular lesions on the face.
Patients who are surgically sterile, 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 Day 0. Patients using birth control pills must have used the same product and dose for at least 6 months and must agree to stay with the same product and dose for an additional 6 months.
Patients must be willing and capable of following study instructions to the extent and degree required by the protocol.
Patients must sign the approved informed consent form prior to any study procedures.
Patients must be willing to be photographed. Patients must be willing to sign a photography consent form.

Exclusion Criteria:

Known allergy to MAL, to a similar PDT compound, or to excipients of the cream.
Participation in other clinical studies either concurrently or within the last 30 days.
Patients who have a condition or who are in a situation, which, in the investigator's opinion, may put the patient at risk, may confound the study results, or may interfere with the patient's participation in the study.
Clinically significant sensitivity to visible light, or has porphyria or porphyrin sensitivity.
Exposure to ultraviolet radiation (UVB phototherapy, sun tanning salons) within the last 30 days.
Patients with a washout period for topical treatments for their acne of less than 14 days. Medicated cleansers may be used during the washout period and stopped before the treatment.
Patients with a washout period for oral antibiotics for treatment of their acne of less than 1 month.
Patients with a washout period for oral isotretinoin of less than 6 months.
Patients with a beard or other facial hair that might interfere with study assessments.

Name	Affiliation	Role
David Pariser, MD	AAD	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Therapeutics Clinical Research		San Diego	California	92123	United States
Solano Clinical Research

Results Section

Participant Flow Module

ID	Title	Description
FG000	40 mg/g MAL PDT
FG001	80 mg/g MAL PDT
FG002	Vehicle PDT

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

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	BG00011 BG00117 BG00211 BG003

Age Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00021.6± 5.24 BG00120.2± 4.81 BG002

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00028 BG00127 BG002

Region of Enrollment

Number

participants

Title

Denominators

Categories

United States

Title	Measurements
	BG00050 BG00148 BG002

Inflammatory lesion count

Mean

Full Range

lesions

Title

Denominators

Categories

Title	Measurements
	BG00034.2(20 to 81) BG00132.1(19 to 60) BG002

Non inflammatory lesion count

Mean

Full Range

lesions

Title

Denominators

Categories

Title	Measurements
	BG00039.1(4 to 99) BG00135.9(5 to 111) BG002

Investigator's Global Assessment (IGA) Score

Number

participants

Title

Denominators

Categories

IGA SCORE 3 (MODERATE ACNE)

Title	Measurements
	BG00035 BG00141 BG002

Fitzpatrick Skin type

The patients is scored according to a predefined description of 4 different skin types.

I White; very fair; red or blond hair; blue eyes; freckles Always burns, never tans

II White; fair; red or blond hair; blue, hazel or green eyes Usually burns, tans with difficulty

III Cream white; fair with any eye or hair color; very common Sometimes mild burn, gradually tans

IV Brown; typical Mediterranean Caucasian skin Rarely burns, tans with ease

Number

participants

Title

Denominators

Categories

Fitzpatrick skin type score I

Title	Measurements
	BG0004 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

Secondary

Median Percentage Change in Facial Inflammatory (Nodules, Papules, and Pustules) Lesion Counts From Baseline

PP population: excludes all patients with major protocol deviations (consists of the following types of events: Baseline inflammatory lesion count other than 20-100, received less that 4 treatments, primary efficacy criteria missing at week 12, insufficient primary efficacy follow up time, prohibited concomitant medication (retinoid).

Posted

Median

Full Range

Percentage change

3 weeks after last treatment

ID	Title	Description
OG000	40 mg/g MAL PDT
OG001	80 mg/g MAL PDT
OG002	Vehicle PDT

Units	Counts
Participants	OG00040 OG00133 OG00242

Title

Denominators

Categories

Title	Measurements
	OG000-44.5± 39,32(-89 to 42) OG001-56.0± 44-34(-95 to 44) OG002-40.5± 34-41(-100 to 71)

Secondary

Median Percentage Change in Facial Inflammatory (Nodules, Papules, and Pustules) Lesion Counts From Baseline

Posted

Median

Full Range

Percentage change

6 weeks after last treatment

ID	Title	Description
OG000	40 mg/g MAL PDT
OG001	80 mg/g MAL PDT
OG002	Vehicle PDT

Units	Counts
Participants	OG000

Secondary

Median Percentage Change in Facial Non Inflammatory Lesion Counts From Baseline

Posted

Median

Full Range

Percentage change

6 weeks after last treatment

ID	Title	Description
OG000	40 mg/g MAL PDT
OG001	80 mg/g MAL PDT
OG002	Vehicle PDT

Units	Counts
Participants	OG000

Primary

Proportion of Success, Defined as Improvement of at Least 2 Grades From Baseline According to the IGA Scale Based on Facial Assessment

ITT population

Posted

Number

95% Confidence Interval

Percentage of participants

12 weeks after last treatment

ID	Title	Description
OG000	40 mg/g MAL PDT
OG001	80 mg/g MAL PDT
OG002	Vehicle PDT

Units	Counts
Participants	OG000

Primary

Change in Facial Inflammatory (Nodules, Papules, and Pustules) Lesion Counts

ITT population

Posted

Least Squares Mean

95% Confidence Interval

lesions

12 weeks after last treatment

ID	Title	Description
OG000	40 mg/g MAL PDT
OG001	80 mg/g MAL PDT
OG002	Vehicle PDT

Units	Counts
Participants	OG000

Secondary

Percent Reduction in Total Lesion Counts From Baseline

Posted

Median

Full Range

Percentage change

6 weeks after last treatment

ID	Title	Description
OG000	40 mg/g MAL PDT
OG001	80 mg/g MAL PDT
OG002	Vehicle PDT

Units	Counts
Participants	OG000

Secondary

Proportion of Success, Defined as Improvement of at Least 2 Grades From Baseline According to the IGA Scale Based on Facial Assessment

Posted

Number

Precentage of participants

6 weeks after last treatment

ID	Title	Description
OG000	40 mg/g MAL PDT
OG001	80 mg/g MAL PDT
OG002	Vehicle PDT

Units	Counts
Participants	OG000

Secondary

The Proportion of Patients Rated as Clear or Almost Clear at 12 Weeks After Last Treatment

Posted

Number

percentage of participants

12 weeks after last treatment

ID	Title	Description
OG000	40 mg/g MAL PDT
OG001	80 mg/g MAL PDT
OG002	Vehicle PDT

Units	Counts
Participants	OG000

Secondary

Facial Pain Using Visual Analouge Scale From 0 to 10, Were 0 Indicates no Pain and 10 Indicates Worst Pain.

Measure was assessed on a Visual Analogue Scale from 0 to 10 cm

Safety

Posted

Median

Full Range

immediately after illumination-first treatment

ID	Title	Description
OG000	40 mg/g MAL PDT
OG001	80 mg/g MAL PDT
OG002	Vehicle PDT

Units	Counts
Participants	OG000

Secondary

Facial Pain Using Visual Analouge Scale From 0 to 10, Were 0 Indicates no Pain and 10 Indicates Worst Pain

Measure was assessed on a Visual Analogue Scale from 0 to 10 cm

Safety

Posted

Mean

Full Range

immediately after second treatment

ID	Title	Description
OG000	40 mg/g MAL PDT
OG001	80 mg/g MAL PDT
OG002	Vehicle PDT

Units	Counts
Participants	OG000

Secondary

Facial Pain Using Visual Analouge Scale From 0 to 10, Were 0 Indicates no Pain and 10 Indicates Worst Pain.

Measure was assessed on a Visual Analogue Scale from 0 to 10 cm

Safety

Posted

Median

Full Range

immediately after third treatment

ID	Title	Description
OG000	40 mg/g MAL PDT
OG001	80 mg/g MAL PDT
OG002	Vehicle PDT

Units	Counts
Participants	OG000

Secondary

Facial Pain Using Visual Analouge Scale From 0 to 10, Were 0 Indicates no Pain and 10 Indicates Worst Pain.

Measure was assessed on a Visual Analogue Scale from 0 to 10 cm

Safety

Posted

Median

Full Range

immediately after illumination-fourth treatment treatment

ID	Title	Description
OG000	40 mg/g MAL PDT
OG001	80 mg/g MAL PDT
OG002	Vehicle PDT

Units	Counts
Participants	OG000

Secondary

Proportion of Patients With Mild and Moderate Erythema After First Treatment

Safety

Posted

Number

percentage of participants

immediately after first treatment

ID	Title	Description
OG000	40 mg/g MAL PDT
OG001	80 mg/g MAL PDT
OG002	Vehicle PDT

Units	Counts
Participants	OG000

Secondary

Proportion of Patients With Mild and Moderate Erythema After First Treatment

Safety

Posted

Number

percentage of participants

2 days after first treatment

ID	Title	Description
OG000	40 mg/g MAL PDT
OG001	80 mg/g MAL PDT
OG002	Vehicle PDT

Units	Counts
Participants	OG000

Secondary

Proportion of Patients With Mild and Moderate Erythema After Second Treatment

Safety

Posted

Number

percentage of participants

immediately after second treatment

ID	Title	Description
OG000	40 mg/g MAL PDT
OG001	80 mg/g MAL PDT
OG002	Vehicle PDT

Units	Counts
Participants	OG000

Secondary

Proportion of Patients With Mild and Moderate Erythema After Third Treatment

Safety

Posted

Number

percentage of participants

immediately after third treatment

ID	Title	Description
OG000	40 mg/g MAL PDT
OG001	80 mg/g MAL PDT
OG002	Vehicle PDT

Units	Counts
Participants	OG000

Secondary

Proportion of Patients With Mild and Moderate Erythema After Fourth Treatment

Safety

Posted

Number

percentage of participants

immediately after fourth treatment

ID	Title	Description
OG000	40 mg/g MAL PDT
OG001	80 mg/g MAL PDT
OG002	Vehicle PDT

Units	Counts
Participants	OG000

Secondary

Proportion of Patients With Severe Erythema After First Treatment

Safety

Posted

Number

percentage of participants

immediately after first treatment

ID	Title	Description
OG000	40 mg/g MAL PDT
OG001	80 mg/g MAL PDT
OG002	Vehicle PDT

Units	Counts
Participants	OG000

Secondary

Proportion of Patients With Severe Erythema 2 Days After First Treatment

Safety

Posted

Number

percentage of participants

2 days after first treatment

ID	Title	Description
OG000	40 mg/g MAL PDT
OG001	80 mg/g MAL PDT
OG002	Vehicle PDT

Units	Counts
Participants	OG000

Secondary

Proportion of Patients With Severe Erythema 7 Days After First Treatment

Safety

Posted

Number

percentage of participants

7 days after first treatment

ID	Title	Description
OG000	40 mg/g MAL PDT
OG001	80 mg/g MAL PDT
OG002	Vehicle PDT

Units	Counts
Participants	OG000

Secondary

Proportion of Patients With Severe Erythema After Second Treatment

Safety

Posted

Number

percentage of participants

immediately after second treatment

ID	Title	Description
OG000	40 mg/g MAL PDT
OG001	80 mg/g MAL PDT
OG002	Vehicle PDT

Units	Counts
Participants	OG000

Secondary

Proportion of Patients With Severe Erythema After Third Treatment

Safety

Posted

Number

percentage of participants

immediately after third treatment

ID	Title	Description
OG000	40 mg/g MAL PDT
OG001	80 mg/g MAL PDT
OG002	Vehicle PDT

Units	Counts
Participants	OG000

Secondary

Proportion of Patients With Severe Erythema After Fourth Treatment

Safety

Posted

Number

percentage of participants

immediately after fourth treatment

ID	Title	Description
OG000	40 mg/g MAL PDT
OG001	80 mg/g MAL PDT
OG002	Vehicle PDT

Units	Counts
Participants	OG000

Secondary

Proportion of Patients With Mild and Moderate Hyperpigmentation After First Treatment

Safety

Posted

Number

percentage of participants

2 days after treatment

ID	Title	Description
OG000	40 mg/g MAL PDT
OG001	80 mg/g MAL PDT
OG002	Vehicle PDT

Units	Counts
Participants	OG000

Secondary

Proportion of Patients With Mild and Moderate Hyperpigmentation After First Treatment

Safety

Posted

Number

percentage of participants

2 weeks after first treatment

ID	Title	Description
OG000	40 mg/g MAL PDT
OG001	80 mg/g MAL PDT
OG002	Vehicle PDT

Units	Counts
Participants	OG000

Secondary

Proportion of Patients With Mild and Moderate Hyperpigmentation After Last Treatment

Safety

Posted

Number

percentage of participants

2 weeks after last treatment

ID	Title	Description
OG000	40 mg/g MAL PDT
OG001	80 mg/g MAL PDT
OG002	Vehicle PDT

Units	Counts
Participants	OG000

Secondary

Proportion of Patients With Mild and Moderate Hyperpigmentation After Last Treatment

Safety

Posted

Number

percentage of participants

6 weeks after last treatment

ID	Title	Description
OG000	40 mg/g MAL PDT
OG001	80 mg/g MAL PDT
OG002	Vehicle PDT

Units	Counts
Participants	OG000

Secondary

Proportion of Patients With Mild and Moderate Hyperpigmentation After Last Treatment

Safety

Posted

Number

percentage of participants

12 weeks after last treatment

ID	Title	Description
OG000	40 mg/g MAL PDT
OG001	80 mg/g MAL PDT
OG002	Vehicle PDT

Units	Counts
Participants	OG000

Secondary

Proportion of Patients With Mild and Moderate Hypopigmentation After First Treatment

Safety

Posted

Number

percentage of participants

2 days after first treatment

ID	Title	Description
OG000	40 mg/g MAL PDT
OG001	80 mg/g MAL PDT
OG002	Vehicle PDT

Units	Counts
Participants	OG000

Secondary

Proportion of Patients With Mild and Moderate Hypopigmentation After Last Treatment

Safety

Posted

Number

percentage of participants

2 weeks after last treatment

ID	Title	Description
OG000	40 mg/g MAL PDT
OG001	80 mg/g MAL PDT
OG002	Vehicle PDT

Units	Counts
Participants	OG000

Secondary

Proportion of Patients With Mild and Moderate Hypopigmentation After First Treatment

Safety

Posted

Number

percentage of participants

2 weeks after first treatment

ID	Title	Description
OG000	40 mg/g MAL PDT
OG001	80 mg/g MAL PDT
OG002	Vehicle PDT

Units	Counts
Participants	OG000

Secondary

Proportion of Patients With Mild and Moderate Hypopigmentation After Last Treatment

Safety

Posted

Number

percentage of participants

6 weeks after last treatment

ID	Title	Description
OG000	40 mg/g MAL PDT
OG001	80 mg/g MAL PDT
OG002	Vehicle PDT

Units	Counts
Participants	OG000

Primary

Proportion of Success, Defined as Improvement of at Least 2 Grades From Baseline According to the IGA Scale Based on Facial Assessment

Posted

Number

percentage of participants

12 weeks after last treatment

ID	Title	Description
OG000	40 mg/g MAL PDT
OG001	80 mg/g MAL PDT
OG002	Vehicle PDT

Units	Counts
Participants	OG000

Primary

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

Posted

Least Squares Mean

95% Confidence Interval

lesions

12 weeks

ID	Title	Description
OG000	40 mg/g MAL PDT
OG001	80 mg/g MAL PDT
OG002	Vehicle PDT

Units	Counts
Participants	OG000

Secondary

Proportion of Patients With Mild and Moderate Hypopigmentation After Last Treatment

Safety

Posted

Number

percentage of participants

12 weeks after last treatment

ID	Title	Description
OG000	40 mg/g MAL PDT
OG001	80 mg/g MAL PDT
OG002	Vehicle PDT

Units	Counts
Participants	OG000

Other Adverse Events

Term	Organ System	Statistical Information
APPLICATION SITE DISCOLOURATION	Skin and subcutaneous tissue disorders	EG0003 affected50 at risk EG0017 affected48 at risk EG0023 affected52 at risk
APPLICATION SITE DRYNESS	Skin and subcutaneous tissue disorders	EG0001 affected50 at risk EG0013 affected48 at risk EG0020 affected52 at risk
APPLICATION SITE ERYTHEMA	Skin and subcutaneous tissue disorders	EG00040 affected50 at risk EG00135 affected48 at risk EG00217 affected52 at risk
APPLICATION SITE EXFOLIATION	Skin and subcutaneous tissue disorders	EG0003 affected50 at risk EG0013 affected48 at risk EG0020 affected52 at risk
APPLICATION SITE IRRITATION	Skin and subcutaneous tissue disorders	EG00031 affected50 at risk EG00126 affected48 at risk EG0024 affected52 at risk
APPLICATION SITE PAIN	Skin and subcutaneous tissue disorders	EG00032 affected50 at risk EG00131 affected48 at risk EG0025 affected52 at risk
APPLICATION SITE PARAESTHESIA	Skin and subcutaneous tissue disorders	EG0003 affected50 at risk EG0019 affected48 at risk EG0024 affected52 at risk
APPLICATION SITE PRURITUS	Skin and subcutaneous tissue disorders	EG00013 affected50 at risk EG00110 affected48 at risk EG0025 affected52 at risk
APPLICATION SITE SCAB	Skin and subcutaneous tissue disorders	EG0003 affected50 at risk EG0013 affected48 at risk EG0020 affected52 at risk
APPLICATION SITE WARMTH	Skin and subcutaneous tissue disorders	EG0002 affected50 at risk EG0010 affected48 at risk EG0024 affected52 at risk
INFLUENZA	Infections and infestations	EG0000 affected50 at risk EG0011 affected48 at risk EG0024 affected52 at risk
NASOPHARYNGITIS	Infections and infestations	EG0003 affected50 at risk EG0011 affected48 at risk EG0021 affected52 at risk
SEASONAL ALLERGY	Immune system disorders	EG0000 affected50 at risk EG0013 affected48 at risk EG0021 affected52 at risk
SINUSITIS	Infections and infestations	EG0000 affected50 at risk EG0014 affected48 at risk EG0024 affected52 at risk
UPPER RESPIRATORY TRACT INFECTION	Infections and infestations	EG0009 affected50 at risk EG0013 affected48 at risk EG0029 affected52 at risk
Headache	Nervous system disorders	EG0002 affected50 at risk EG0012 affected48 at risk EG0020 affected52 at risk

Term	Organ System	Statistical Information
CELLULITIS STAPHYLOCOCCAL	Infections and infestations	EG0001 affected50 at risk EG0010 affected48 at risk EG0020 affected52 at risk
PREGNANCY	Pregnancy, puerperium and perinatal conditions	EG0001 affected50 at risk EG0010 affected48 at risk EG0020 affected52 at risk
ABORTION SPONTANEOUS	Pregnancy, puerperium and perinatal conditions	EG0001 affected50 at risk EG0010 affected48 at risk EG0020 affected52 at risk

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

ID	Term
C475457	methyl 5-aminolevulinate
C008848	1-phenyl-3,3-dimethyltriazene

ID	Title	Description
BG000	40 mg/g MAL PDT
BG001	80 mg/g MAL PDT
BG002	Vehicle PDT
BG003	Total	Total of all reporting groups

ID	Title	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	40 mg/g MAL PDT	2	50	50	50
EG001	80 mg/g MAL PDT	0	48	46	48
EG002	Vehicle PDT	0	52	38	52