Trial Outcomes & Findings for Efficacy and Safety Study With Visonac Photodynamic Therapy (PDT) (NCT NCT00933543)

NCT ID: NCT00933543

Last Updated: 2013-12-11

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 107 participants
• Primary outcome timeframe: 12 weeks after the first treatment
• Results posted on: 2013-12-11

Participant Flow

Recruitment from September-December 2009. Dermatology clinics, with pediatric patients

Participant milestones

Measure	Visonac Cream With PDT Active treatment, Light dose 37 J/cm2.	Vehicle Cream With PDT Placebo treatment, Light dose 37 J/cm2.
Overall Study STARTED	54	53
Overall Study COMPLETED	51	46
Overall Study NOT COMPLETED	3	7

Reasons for withdrawal

Measure	Visonac Cream With PDT Active treatment, Light dose 37 J/cm2.	Vehicle Cream With PDT Placebo treatment, Light dose 37 J/cm2.
Overall Study Adverse Event	2	1
Overall Study Lost to Follow-up	0	1
Overall Study Withdrawal by Subject	0	1
Overall Study Lack of Efficacy	0	3
Overall Study Other	1	1

Baseline Characteristics

Efficacy and Safety Study With Visonac Photodynamic Therapy (PDT)

Baseline characteristics by cohort

Measure	Visonac Cream With PDT n=54 Participants Active treatment, Light dose 37 J/cm2.	Vehicle Cream With PDT n=53 Participants Placebo treatment, Light dose 37 J/cm2.	Total n=107 Participants Total of all reporting groups
Patients with dryness No dryness	45 Number of patients n=5 Participants	46 Number of patients n=7 Participants	91 Number of patients n=5 Participants
Patients with dryness Mild dryness	9 Number of patients n=5 Participants	7 Number of patients n=7 Participants	16 Number of patients n=5 Participants
Age, Categorical <=18 years	35 Participants n=5 Participants	34 Participants n=7 Participants	69 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	19 Participants n=5 Participants	19 Participants n=7 Participants	38 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	32 Participants n=5 Participants	27 Participants n=7 Participants	59 Participants n=5 Participants
Sex: Female, Male Male	22 Participants n=5 Participants	26 Participants n=7 Participants	48 Participants n=5 Participants
Region of Enrollment Canada	17 participants n=5 Participants	16 participants n=7 Participants	33 participants n=5 Participants
Region of Enrollment United States	37 participants n=5 Participants	37 participants n=7 Participants	74 participants n=5 Participants
Patients with mild and moderate hyperpigmentation No hyperpigmentation	39 number of patients n=5 Participants	34 number of patients n=7 Participants	73 number of patients n=5 Participants
Patients with mild and moderate hyperpigmentation Mild hyperpigmentation	5 number of patients n=5 Participants	10 number of patients n=7 Participants	15 number of patients n=5 Participants
Patients with mild and moderate hyperpigmentation Moderate hyperpigmentation	8 number of patients n=5 Participants	8 number of patients n=7 Participants	16 number of patients n=5 Participants
Patients with mild and moderate hyperpigmentation Severe hyperpigmentation	2 number of patients n=5 Participants	1 number of patients n=7 Participants	3 number of patients n=5 Participants
Investigator Global Assessment (IGA) Score IGA 3 (Moderate acne)	44 participants n=5 Participants	45 participants n=7 Participants	89 participants n=5 Participants
Investigator Global Assessment (IGA) Score IGA 4 (Severe acne)	10 participants n=5 Participants	8 participants n=7 Participants	18 participants n=5 Participants
Fitzpatrick Skin type Skin type I	5 participants n=5 Participants	6 participants n=7 Participants	11 participants n=5 Participants
Fitzpatrick Skin type Skin type II	14 participants n=5 Participants	15 participants n=7 Participants	29 participants n=5 Participants
Fitzpatrick Skin type Skin type III	24 participants n=5 Participants	21 participants n=7 Participants	45 participants n=5 Participants
Fitzpatrick Skin type Skin type IV	4 participants n=5 Participants	6 participants n=7 Participants	10 participants n=5 Participants
Fitzpatrick Skin type Skin type V	5 participants n=5 Participants	2 participants n=7 Participants	7 participants n=5 Participants
Fitzpatrick Skin type Skin type VI	2 participants n=5 Participants	3 participants n=7 Participants	5 participants n=5 Participants
Scarring Patients with no scarring	21 number of patients n=5 Participants	26 number of patients n=7 Participants	47 number of patients n=5 Participants
Scarring Patients with almost clear scarring	9 number of patients n=5 Participants	10 number of patients n=7 Participants	19 number of patients n=5 Participants
Scarring Patients with mild scarring	15 number of patients n=5 Participants	9 number of patients n=7 Participants	24 number of patients n=5 Participants
Scarring Patients with moderate scarring	6 number of patients n=5 Participants	6 number of patients n=7 Participants	12 number of patients n=5 Participants
Scarring Patients with severe scarring	3 number of patients n=5 Participants	1 number of patients n=7 Participants	4 number of patients n=5 Participants
Scarring Patients with very severe scarring	0 number of patients n=5 Participants	1 number of patients n=7 Participants	1 number of patients n=5 Participants

PRIMARY outcome

Timeframe: 12 weeks after the first treatment

Population: ITT

Outcome measures

Measure	Visonac Cream With PDT n=54 Participants Active treatment, Light dose 37 J/cm2.	Vehicle Cream With PDT n=53 Participants Placebo treatment, Light dose 37 J/cm2.
Proportion of Patients With Success According to the Dichotomized IGA Scale Based on Facial Assessments 12 Weeks After the First Treatment. Success is Defined as an Improvement of at Least 2 Grades From the Baseline Score.	9.26 percentage of participants Interval 1.53 to 16.99	1.89 percentage of participants Interval 0.0 to 5.55

PRIMARY outcome

Timeframe: 12 weeks after the first treatment

Population: ITT

Outcome measures

Measure	Visonac Cream With PDT n=54 Participants Active treatment, Light dose 37 J/cm2.	Vehicle Cream With PDT n=53 Participants Placebo treatment, Light dose 37 J/cm2.
Absolute Change From Baseline in Facial Inflammatory Lesion Count (Nodules, Papules, and Pustules)	-14.0 lesions Standard Deviation 17.94	-13.8 lesions Standard Deviation 23.76

PRIMARY outcome

Timeframe: 12 weeks after first treatment

Population: ITT

Outcome measures

Measure	Visonac Cream With PDT n=54 Participants Active treatment, Light dose 37 J/cm2.	Vehicle Cream With PDT n=53 Participants Placebo treatment, Light dose 37 J/cm2.
Absolute Change From Baseline in Facial Non Inflammatory Lesion Count	-14.3 lesions Standard Deviation 26.54	-17.1 lesions Standard Deviation 25.84

SECONDARY outcome

Timeframe: 6 weeks after the first treatment

Population: ITT

Outcome measures

Measure	Visonac Cream With PDT n=54 Participants Active treatment, Light dose 37 J/cm2.	Vehicle Cream With PDT n=53 Participants Placebo treatment, Light dose 37 J/cm2.
Percent Change From Baseline in Facial Inflammatory (Nodules, Papules, and Pustules)Lesion Count	-35.4 percent change from baseline Standard Deviation 30.85	-20.3 percent change from baseline Standard Deviation 38.72

SECONDARY outcome

Timeframe: 12 weeks after the first treatment

Population: ITT

Outcome measures

Measure	Visonac Cream With PDT n=54 Participants Active treatment, Light dose 37 J/cm2.	Vehicle Cream With PDT n=53 Participants Placebo treatment, Light dose 37 J/cm2.
Percent Change From Baseline in Facial Inflammatory (Nodules, Papules, and Pustules)Lesion Count	-33.1 Percent change from baseline Standard Deviation 39.34	-27.5 Percent change from baseline Standard Deviation 44.38

SECONDARY outcome

Timeframe: 6 weeks after first treatment

Population: ITT

Outcome measures

Measure	Visonac Cream With PDT n=54 Participants Active treatment, Light dose 37 J/cm2.	Vehicle Cream With PDT n=53 Participants Placebo treatment, Light dose 37 J/cm2.
Percent Change From Baseline in Facial Non Inflammatory Lesion Count	-25.3 percentage change from baseline Standard Deviation 39.72	-15.8 percentage change from baseline Standard Deviation 47.11

SECONDARY outcome

Timeframe: 12 weeks after first treatment

Population: ITT

Outcome measures

Measure	Visonac Cream With PDT n=54 Participants Active treatment, Light dose 37 J/cm2.	Vehicle Cream With PDT n=53 Participants Placebo treatment, Light dose 37 J/cm2.
Percent Change From Baseline in Facial Non Inflammatory Lesion Count	-26.0 percentage change from baseline Standard Deviation 52.23	-24.4 percentage change from baseline Standard Deviation 37.66

SECONDARY outcome

Timeframe: 6 weeks after the first treatment

Population: ITT

Outcome measures

Measure	Visonac Cream With PDT n=52 Participants Active treatment, Light dose 37 J/cm2.	Vehicle Cream With PDT n=52 Participants Placebo treatment, Light dose 37 J/cm2.
Percent Change From Baseline in Facial Total Lesion Count	-29.5 Percent change from baseline Standard Deviation 27.72	-18.0 Percent change from baseline Standard Deviation 35.39

SECONDARY outcome

Timeframe: 12 weeks after the first treatment

Population: ITT

Outcome measures

Measure	Visonac Cream With PDT n=54 Participants Active treatment, Light dose 37 J/cm2.	Vehicle Cream With PDT n=53 Participants Placebo treatment, Light dose 37 J/cm2.
Percent Change From Baseline in Facial Total Lesion Count	-29.8 Percent change from baseline Standard Deviation 36.04	-26.8 Percent change from baseline Standard Deviation 29.61

SECONDARY outcome

Timeframe: 12 weeks after last treatment

Population: ITT

Outcome measures

Measure	Visonac Cream With PDT n=54 Participants Active treatment, Light dose 37 J/cm2.	Vehicle Cream With PDT n=53 Participants Placebo treatment, Light dose 37 J/cm2.
Proportion of Patients With a Reduction of at Least 50% From Baseline in Facial Non-inflammatory Lesion Count	17 participants	10 participants

SECONDARY outcome

Timeframe: 12 weeks after first treatment

Outcome measures

Measure	Visonac Cream With PDT n=54 Participants Active treatment, Light dose 37 J/cm2.	Vehicle Cream With PDT n=53 Participants Placebo treatment, Light dose 37 J/cm2.
Proportion of Patients With a Reduction of at Least 50% From Baseline in Facial Inflammatory Lesion Count From Baseline	20 participants	19 participants

SECONDARY outcome

Timeframe: 6 weeks after the first treatment

Population: ITT

Outcome measures

Measure	Visonac Cream With PDT n=52 Participants Active treatment, Light dose 37 J/cm2.	Vehicle Cream With PDT n=52 Participants Placebo treatment, Light dose 37 J/cm2.
Absolute Change From Baseline in Facial Inflammatory Lesion Count	-17.5 lesions Standard Deviation 9.0	-10.8 lesions Standard Deviation 22.41

SECONDARY outcome

Timeframe: 6 weeks after the first treatment

Population: ITT

Outcome measures

Measure	Visonac Cream With PDT n=52 Participants Active treatment, Light dose 37 J/cm2.	Vehicle Cream With PDT n=52 Participants Placebo treatment, Light dose 37 J/cm2.
Absolute Change From Baseline in Facial Non- Inflammatory Lesion Count	12.9 lesions Standard Deviation 21.41	11.3 lesions Standard Deviation 28.24

SECONDARY outcome

Timeframe: 6 weeks after the first treatment

Population: ITT

Outcome measures

Measure	Visonac Cream With PDT n=52 Participants Active treatment, Light dose 37 J/cm2.	Vehicle Cream With PDT n=52 Participants Placebo treatment, Light dose 37 J/cm2.
Absolute Change From Baseline in Facial Total Lesion Count	-27.2 lesions Standard Deviation 26.19	-20.6 lesions Standard Deviation 36.68

SECONDARY outcome

Timeframe: 6 weeks after the first treatment

Population: ITT

Outcome measures

Measure	Visonac Cream With PDT n=52 Participants Active treatment, Light dose 37 J/cm2.	Vehicle Cream With PDT n=52 Participants Placebo treatment, Light dose 37 J/cm2.
Proportion of Patients With Success According to the Dichotomized IGA Scale Based on Facial Assessments 12 Weeks After the First Treatment. Success is Defined as an Improvement of at Least 2 Grades From the Baseline Score.	3 Participants	1 Participants

SECONDARY outcome

Timeframe: directly after first treatment

Population: Safety population

Facial pain was assessed on a visual analogue scale ranging from 0-10cm.

Outcome measures

Measure	Visonac Cream With PDT n=54 Participants Active treatment, Light dose 37 J/cm2.	Vehicle Cream With PDT n=53 Participants Placebo treatment, Light dose 37 J/cm2.
Facial Pain Assessed Using a Visual Analogue Scale From 0 to 10, Where 0 Indicates no Pain and 10 Indicates Worst Pain Imaginable	1.5 cm Full Range 2.2 • Interval 0.0 to 9.8	0.28 cm Full Range 0.64 • Interval 0.0 to 3.6

SECONDARY outcome

Timeframe: directly after second treatment

Population: Safety population

Facial pain was assessed on a visual analogue scale ranging from 0-10cm.

Outcome measures

Measure	Visonac Cream With PDT n=52 Participants Active treatment, Light dose 37 J/cm2.	Vehicle Cream With PDT n=52 Participants Placebo treatment, Light dose 37 J/cm2.
Facial Pain Assessed Using a Visual Analogue Scale From 0 to 10, Where 0 Indicates no Pain and 10 Indicates Worst Pain Imaginable	1.37 cm Interval 0.0 to 8.5	0.15 cm Interval 0.0 to 1.6

SECONDARY outcome

Timeframe: directly after third treatment

Population: Safety population

Facial pain was assessed on a visual analogue scale ranging from 0-10cm.

Outcome measures

Measure	Visonac Cream With PDT n=51 Participants Active treatment, Light dose 37 J/cm2.	Vehicle Cream With PDT n=50 Participants Placebo treatment, Light dose 37 J/cm2.
Facial Pain Assessed Using a Visual Analogue Scale From 0 to 10, Where 0 Indicates no Pain and 10 Indicates Worst Pain Imaginable	1.53 cm Interval 0.0 to 8.1	0.17 cm Interval 0.0 to 1.4

SECONDARY outcome

Timeframe: directly after fourth treatment

Population: Safety population

Facial pain was assessed on a visual analogue scale ranging from 0-10cm.

Outcome measures

Measure	Visonac Cream With PDT n=51 Participants Active treatment, Light dose 37 J/cm2.	Vehicle Cream With PDT n=49 Participants Placebo treatment, Light dose 37 J/cm2.
Facial Pain Assessed Using a Visual Analogue Scale From 0 to 10, Where 0 Indicates no Pain and 10 Indicates Worst Pain Imaginable	1.39 cm Interval 0.0 to 8.2	0.19 cm Interval 0.0 to 2.6

SECONDARY outcome

Timeframe: at 12 weeks after first treatment

Population: Safety

Outcome measures

Measure	Visonac Cream With PDT n=54 Participants Active treatment, Light dose 37 J/cm2.	Vehicle Cream With PDT n=49 Participants Placebo treatment, Light dose 37 J/cm2.
Proportion of Patients With Mild and Moderate Hyperpigmentation	26 participants	32 participants

SECONDARY outcome

Timeframe: at 12 weeks after first treatment

Population: Safety

Outcome measures

Measure	Visonac Cream With PDT n=54 Participants Active treatment, Light dose 37 J/cm2.	Vehicle Cream With PDT n=49 Participants Placebo treatment, Light dose 37 J/cm2.
Proportion of Patients With Severe Hyperpigmentation	1 participants	0 participants

SECONDARY outcome

Timeframe: week 12

Outcome measures

Measure	Visonac Cream With PDT n=54 Participants Active treatment, Light dose 37 J/cm2.	Vehicle Cream With PDT n=49 Participants Placebo treatment, Light dose 37 J/cm2.
Proportion of Patients With Mild or Moderate Scarring at End of Study	36 participants	34 participants

SECONDARY outcome

Timeframe: week 12

Outcome measures

Measure	Visonac Cream With PDT n=54 Participants Active treatment, Light dose 37 J/cm2.	Vehicle Cream With PDT n=49 Participants Placebo treatment, Light dose 37 J/cm2.
Proportion of Patients With Clear or Almost Clear Scarring at End of Study	59 participants	63 participants

SECONDARY outcome

Timeframe: week 12

Outcome measures

Measure	Visonac Cream With PDT n=54 Participants Active treatment, Light dose 37 J/cm2.	Vehicle Cream With PDT n=49 Participants Placebo treatment, Light dose 37 J/cm2.
Proportion of Patients With Severe and Very Severe Scarring at End of Study	6 participants	2 participants

SECONDARY outcome

Timeframe: at 12 weeks after first treatment

Population: Safety

Outcome measures

Measure	Visonac Cream With PDT n=54 Participants Active treatment, Light dose 37 J/cm2.	Vehicle Cream With PDT n=49 Participants Placebo treatment, Light dose 37 J/cm2.
Proportion of Patients With Hypopigmentation (Mild Moderate, Severe)	0 participants	0 participants

SECONDARY outcome

Timeframe: at 12 weeks after first treatment

Population: Safety

Outcome measures

Measure	Visonac Cream With PDT n=54 Participants Active treatment, Light dose 37 J/cm2.	Vehicle Cream With PDT n=49 Participants Placebo treatment, Light dose 37 J/cm2.
Proportion of Patients With Dryness (Mild)	20 participants	16 participants

Adverse Events

Visonac Cream With PDT

Serious events: 0 serious events

Other events: 46 other events

Deaths: 0 deaths

Vehicle Cream With PDT

Serious events: 0 serious events

Other events: 32 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Visonac Cream With PDT n=54 participants at risk Active treatment, Light dose 37 J/cm2.	Vehicle Cream With PDT n=53 participants at risk Placebo treatment, Light dose 37 J/cm2.
Skin and subcutaneous tissue disorders Erythema	48.1% 26/54	17.0% 9/53
Skin and subcutaneous tissue disorders Pruritus	25.9% 14/54	15.1% 8/53
Skin and subcutaneous tissue disorders Skin burning sensation	22.2% 12/54	7.5% 4/53
Skin and subcutaneous tissue disorders Skin irritation	7.4% 4/54	0.00% 0/53
General disorders Pain	50.0% 27/54	11.3% 6/53
General disorders Facial pain	7.4% 4/54	7.5% 4/53
General disorders Feeling hot	3.7% 2/54	3.8% 2/53
Infections and infestations Nasopharyngitis	18.5% 10/54	9.4% 5/53
Nervous system disorders Paraestehesia	16.7% 9/54	1.9% 1/53

Additional Information

Project director Per Fuglerud

Photocure

Phone: +47 22 06 16 54

Email: pf@photocure.no

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: GT60