A Double Blinded, Prospective, Randomized, Vehicle Controlled Multi-center Study of Photodynamic Therapy With Visonac® Cream in Patients With Acne Vulgaris

• Sponsor: Photocure (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01347879
• Collaborator: (none)
• Enrollment: 153
• Locations: 15
• Arms: 2
• Duration (Months): 12
• Patients Per Site: 10.2
• Patients Per Site Per Month: 0.8

Study Details

Study Description

Brief Summary

This study is intended to evaluate the efficacy and safety of Visonac Photodynamic Therapy (PDT) in patients with severe acne, score 4 on global IGA scale. The null hypothesis is that Visonac PDT is equal to vehicle PDT against the alternative hypothesis that Visonac PDT is different compared to vehicle PDT at week 12.

Condition or Disease	Intervention/Treatment	Phase
Acne Vulgaris	Drug: Visonac PDT; Drug: Vehicle cream with PDT	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 153 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: PCTA206/11 A Double Blinded, Prospective, Randomized, Vehicle Controlled Multi Center Study of Photodynamic Therapy With Visonac® Cream in Patients With Acne Vulgaris.
• Study Start Date: May 1, 2011
• Actual Primary Completion Date: Apr 1, 2012
• Actual Study Completion Date: May 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Visonac cream with PDT active treatment with light dose of 37 Joule/cm2	Drug: Visonac PDT; cream application prior to illumination with red light; Other Names: red light
Placebo Comparator: Vehicle cream with PDT Placebo treatment, Light dose 37 Joule/cm2	Drug: Vehicle cream with PDT; placebo/vehicle cream application prior to illumination with red light; Other Names: red light

Outcome Measures

Primary Outcome Measures

1. Absolute Change From Baseline in Facial Inflammatory Lesion Count (Nodules, Papules, and Pustules). [From baseline to 12 weeks after first treatment]

Secondary Outcome Measures

1. Absolute Change From Baseline in Facial Non-inflammatory Lesion Count (Open and Closed Comedones) [From baseline to 12 weeks after the first treatment]

2. Percent Change From Baseline in Facial Inflammatory (Nodules, Papules, and Pustules)Lesion Counts. [From baseline to 12 weeks after the first treatment]

3. Proportion of Patients With Success According to IGA Scale Based on the Facial Assessment. [From baseline to 12 weeks after first treatment]

   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.

4. Pain During Illumination. [Immediately after first treatment]

   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.

5. Number of Patients With Adverse Events. [From administration of investigational medicinal product (IMP) until 12 weeks after first IMP administration]

6. Erythema Score of Mild and Moderate [Immediately after first treatment]

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

7. Clear and Almost Clear Scarring According to Scarring Score [at week 12 after first treatment]

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

8. Percent Change From Baseline in Facial Non-inflammatory Lesion Count (Open and Closed Comedones) [From baseline to 12 weeks after first treatment]

9. Erythema Score of Severe [Immediately after first treatment]

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

10. Erythema Score of Mild and Moderate [2 days after first treatment]

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

11. Erythema Score of Severe [2 days after first treatment]

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

12. Mild and Moderate Scarring According to Scarring Score [at week 12 after first treatment]

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

13. Severe and Very Severe Scarring According to Scarring Score [at week 12 after first treatment]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 12 Years to 35 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Dermatology Specialists Inc	Oceanside	California	United States	92056
2	Rady Children's Hospital	San Diego	California	United States	92123
3	North Florida Dermatology Associates	Jacksonville	Florida	United States	32204
4	Altman Dermatology Associates	Arlington Heights	Illinois	United States	60005
5	Dermatology Institute, DuPage Medical Group	Naperville	Illinois	United States	60563
6	Deaconess Clinic Inc	Evansville	Indiana	United States	47713
7	ActivMed Practices & Research Inc	Haverhill	Massachusetts	United States	10830
8	Hamzavi Dermatology	Fort Gratiot	Michigan	United States	48059
9	Somerset Skin Centre	Troy	Michigan	United States	48084
10	Penn State Hershey Medical Center	Hershey	Pennsylvania	United States	17033
11	Clinical Partners LLC	Johnston	Rhode Island	United States	02919
12	DermResearch Inc	Austin	Texas	United States	78759
13	Clinical Trials of Texas	San Antonio	Texas	United States	78229
14	Virginia Clinical Research, Inc.	Norfolk	Virginia	United States	23507
15	Premier Clinical Research	Spokane	Washington	United States	99216

Sponsors and Collaborators

• Photocure

Investigators

• Principal Investigator: David Pariser, MD, Virginia Clinical Research, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Photocure
• ClinicalTrials.gov Identifier: NCT01347879
• Other Study ID Numbers: PCTA206/11
• First Posted: May 4, 2011
• Last Update Posted: Jan 16, 2014
• Last Verified: Dec 1, 2013

• Keywords provided by Photocure: Acne vulgaris; PDT
• Additional relevant MeSH terms: Acne Vulgaris

Study Results

Participant Flow

Recruitment Details	Dermatology clinics in the US.

Arm/Group Title	Vehicle Cream With PDT	Visonac Cream With PDT
Arm/Group Description	Placebo treatment, Light dose 37 J/cm2 Visonac PDT : cream application prior to illumination with red light	active treatment with light dose of 37 J/cm2 Visonac photodynamic therapy (PDT): cream application prior to illumination with red light
Period Title: Overall Study
STARTED	53	100
COMPLETED	46	83
NOT COMPLETED	7	17

Baseline Characteristics

Arm/Group Title	Vehicle Cream With PDT	Visonac Cream With PDT	Total
Arm/Group Description	Placebo treatment, Light dose 37 J/cm2 Visonac PDT : cream application prior to illumination with red light	active treatment with light dose of 37J/cm2 Visonac PDT : cream application prior to illumination with red light	Total of all reporting groups
Overall Participants	53	100	153
Age (Count of Participants)
<=18 years	35 66%	59 59%	94 61.4%
Between 18 and 65 years	18 34%	41 41%	59 38.6%
>=65 years	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	18.6 (5.8)	18.6 (5.5)	18.6 (5.6)
Sex: Female, Male (Count of Participants)
Female	22 41.5%	44 44%	66 43.1%
Male	31 58.5%	56 56%	87 56.9%
Region of Enrollment (participants) [Number]
United States	53 100%	100 100%	153 100%
Skin type (participants) [Number]
Skin type I	0 0%	1 1%	1 0.7%
Skin type II	24 45.3%	34 34%	58 37.9%
Skin type III	15 28.3%	38 38%	53 34.6%
Skin type IV	7 13.2%	15 15%	22 14.4%
Skin type V	6 11.3%	8 8%	14 9.2%
Skin type VI	1 1.9%	4 4%	5 3.3%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Vehicle Cream With PDT	Visonac Cream With PDT
Arm/Group Description	Placebo treatment, Light dose 37 J/cm2 Visonac PDT : cream application prior to illumination with red light	active treatment with light dose of 37J/cm2 Visonac PDT : cream application prior to illumination with red light
Measure Participants	53	100
Mean (Standard Deviation) [lesion count]	-7.8 (21.4)	-15.6 (16.4)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Vehicle Cream With PDT, Visonac Cream With PDT
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.006
	Comments
	Method	ANCOVA
	Comments	Lesion count at baseline and center as covariates
Method of Estimation	Estimation Parameter	Difference in least square means
	Estimated Value	-7.35
	Confidence Interval	(2-Sided) 95%; -12.5 to -2.2
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Secondary Outcome

Title	Absolute Change From Baseline in Facial Non-inflammatory Lesion Count (Open and Closed Comedones)
Time Frame	From baseline to 12 weeks after the first treatment

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Vehicle Cream With PDT	Visonac Cream With PDT
Arm/Group Description	Placebo treatment, Light dose 37 J/cm2 Visonac PDT : cream application prior to illumination with red light	active treatment with light dose of 37J/cm2 Visonac PDT : cream application prior to illumination with red light
Measure Participants	53	100
Mean (Standard Deviation) [lesion count]	-10.7 (22.1)	-11.8 (19.0)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Vehicle Cream With PDT, Visonac Cream With PDT
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.8527
	Comments
	Method	ANCOVA
	Comments	Lesion count at baseline and center as covariates
Method of Estimation	Estimation Parameter	Difference in least square means
	Estimated Value	-0.6
	Confidence Interval	(2-Sided) 95%; -6.6 to 5.5
	Parameter Dispersion	Type: Value:
	Estimation Comments

3. Secondary Outcome

Title	Percent Change From Baseline in Facial Inflammatory (Nodules, Papules, and Pustules)Lesion Counts.
Time Frame	From baseline to 12 weeks after the first treatment

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Vehicle Cream With PDT	Visonac Cream With PDT
Arm/Group Description	Placebo treatment, Light dose 37 J/cm2 Visonac PDT : cream application prior to illumination with red light	active treatment with light dose of 37J/cm2 Visonac PDT : cream application prior to illumination with red light
Measure Participants	53	100
Median (Full Range) [percent change]	-26.6	-43.8

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Vehicle Cream With PDT, Visonac Cream With PDT
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0032
	Comments
	Method	ANCOVA
	Comments	Lesion count at baseline and center as covariates
Method of Estimation	Estimation Parameter	Difference in least square means
	Estimated Value	-20.0
	Confidence Interval	(2-Sided) 95%; -33.2 to -6.8
	Parameter Dispersion	Type: Value:
	Estimation Comments

4. Secondary Outcome

Title	Proportion of Patients With Success According to IGA Scale Based on the Facial Assessment.
Description	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.
Time Frame	From baseline to 12 weeks after first treatment

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Vehicle Cream With PDT	Visonac Cream With PDT
Arm/Group Description	Placebo treatment, Light dose 37 J/cm2 Visonac PDT : cream application prior to illumination with red light	active treatment with light dose of 37J/cm2 Visonac PDT : cream application prior to illumination with red light
Measure Participants	53	100
Number [participants]	14 26.4%	44 44%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Vehicle Cream With PDT, Visonac Cream With PDT
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0125
	Comments
	Method	Regression, Logistic
	Comments

5. Secondary Outcome

Title	Pain During Illumination.
Description	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.
Time Frame	Immediately after first treatment

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Vehicle Cream With PDT	Visonac Cream With PDT
Arm/Group Description	Placebo treatment, Light dose 37 J/cm2 Visonac PDT : cream application prior to illumination with red light	active treatment with light dose of 37J/cm2 Visonac PDT : cream application prior to illumination with red light
Measure Participants	53	100
Mean (Full Range) [VAS score in cm]	0.52	3.38

6. Secondary Outcome

Title	Number of Patients With Adverse Events.
Time Frame	From administration of investigational medicinal product (IMP) until 12 weeks after first IMP administration

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Vehicle Cream With PDT	Visonac Cream With PDT
Arm/Group Description	Placebo treatment, Light dose 37 J/cm2 Visonac PDT : cream application prior to illumination with red light	active treatment with light dose of 37J/cm2 Visonac PDT : cream application prior to illumination with red light
Measure Participants	53	100
Number [participants]	14 26.4%	48 48%

7. Secondary Outcome

Title	Erythema Score of Mild and Moderate
Description	Clinical assessment using a 4 point scale; none, mild, moderate, severe
Time Frame	Immediately after first treatment

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Vehicle Cream With PDT	Visonac Cream With PDT
Arm/Group Description	Placebo treatment, Light dose 37 J/cm2 Visonac PDT : cream application prior to illumination with red light	active treatment with light dose of 37J/cm2 Visonac PDT : cream application prior to illumination with red light
Measure Participants	53	100
Number [participants]	37 69.8%	86 86%

8. Secondary Outcome

Title	Clear and Almost Clear Scarring According to Scarring Score
Description	Clinical assessment using a 6 point scale; Clear, Almost clear, Mild, Moderate, Severe and Very severe
Time Frame	at week 12 after first treatment

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Vehicle Cream With PDT	Visonac Cream With PDT
Arm/Group Description	Placebo treatment, Light dose 37 J/cm2 Visonac PDT : cream application prior to illumination with red light	active treatment with light dose of 37J/cm2 Visonac PDT : cream application prior to illumination with red light
Measure Participants	46	91
Number [participants]	25 47.2%	53 53%

9. Secondary Outcome

Title	Percent Change From Baseline in Facial Non-inflammatory Lesion Count (Open and Closed Comedones)
Time Frame	From baseline to 12 weeks after first treatment

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Vehicle Cream With PDT	Visonac Cream With PDT
Arm/Group Description	Placebo treatment, Light dose 37 J/cm2 Visonac PDT : cream application prior to illumination with red light	active treatment with light dose of 37J/cm2 Visonac PDT : cream application prior to illumination with red light
Measure Participants	53	100
Median (Full Range) [percent change]	-37.0	-31.0

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Vehicle Cream With PDT, Visonac Cream With PDT
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.7161
	Comments
	Method	ANCOVA
	Comments	Lesion count at baseline and center as covariate
Method of Estimation	Estimation Parameter	Difference in least square means
	Estimated Value	-2.56
	Confidence Interval	(2-Sided) 95%; -16.5 to 11.3
	Parameter Dispersion	Type: Value:
	Estimation Comments

10. Secondary Outcome

Title	Erythema Score of Severe
Description	Clinical assessment using a 4 point scale; none, mild, moderate, severe
Time Frame	Immediately after first treatment

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Vehicle Cream With PDT	Visonac Cream With PDT
Arm/Group Description	Placebo treatment, Light dose 37 J/cm2 Visonac PDT : cream application prior to illumination with red light	active treatment with light dose of 37J/cm2 Visonac PDT : cream application prior to illumination with red light
Measure Participants	53	100
Number [participants]	0 0%	3 3%

11. Secondary Outcome

Title	Erythema Score of Mild and Moderate
Description	Clinical assessment using a 4 point scale; none, mild, moderate, severe
Time Frame	2 days after first treatment

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Vehicle Cream With PDT	Visonac Cream With PDT
Arm/Group Description	Placebo treatment, Light dose 37 J/cm2 Visonac PDT : cream application prior to illumination with red light	active treatment with light dose of 37J/cm2 Visonac PDT : cream application prior to illumination with red light
Measure Participants	53	95
Number [participants]	26 49.1%	65 65%

12. Secondary Outcome

Title	Erythema Score of Severe
Description	Clinical assessment using a 4 point scale; none, mild, moderate, severe
Time Frame	2 days after first treatment

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Vehicle Cream With PDT	Visonac Cream With PDT
Arm/Group Description	Placebo treatment, Light dose 37 J/cm2 Visonac PDT : cream application prior to illumination with red light	active treatment with light dose of 37J/cm2 Visonac PDT : cream application prior to illumination with red light
Measure Participants	53	95
Number [participants]	0 0%	0 0%

13. Secondary Outcome

Title	Mild and Moderate Scarring According to Scarring Score
Description	Clinical assessment using a 6 point scale; Clear, Almost clear, Mild, Moderate, Severe and Very severe
Time Frame	at week 12 after first treatment

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Vehicle Cream With PDT	Visonac Cream With PDT
Arm/Group Description	Placebo treatment, Light dose 37 J/cm2 Visonac PDT : cream application prior to illumination with red light	active treatment with light dose of 37J/cm2 Visonac PDT : cream application prior to illumination with red light
Measure Participants	46	91
Number [participants]	21 39.6%	38 38%

14. Secondary Outcome

Title	Severe and Very Severe Scarring According to Scarring Score
Description	Clinical assessment using a 6 point scale; Clear, Almost clear, Mild, Moderate, Severe and Very severe
Time Frame	at week 12 after first treatment

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Vehicle Cream With PDT	Visonac Cream With PDT
Arm/Group Description	Placebo treatment, Light dose 37 J/cm2 Visonac PDT : cream application prior to illumination with red light	active treatment with light dose of 37J/cm2 Visonac PDT : cream application prior to illumination with red light
Measure Participants	46	91
Number [participants]	0 0%	0 0%

Adverse Events

Arm/Group Title	Vehicle Cream With PDT		Visonac Cream With PDT
Arm/Group Description	Placebo treatment, Light dose 37 J/cm2 Visonac PDT : cream application prior to illumination with red light		active treatment with light dose of 37J/cm2 Visonac PDT : cream application prior to illumination with red light
All Cause Mortality
	Vehicle Cream With PDT		Visonac Cream With PDT
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Vehicle Cream With PDT		Visonac Cream With PDT
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/53 (0%)		0/100 (0%)
Other (Not Including Serious) Adverse Events
	Vehicle Cream With PDT		Visonac Cream With PDT
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	14/53 (26.4%)		48/100 (48%)
Eye disorders
Conjunctivitis bacterial	0/53 (0%)		1/100 (1%)
Gastrointestinal disorders
Nausea	0/53 (0%)		3/100 (3%)
General disorders
Tooth abscess	1/53 (1.9%)		0/100 (0%)
Vomiting	0/53 (0%)		2/100 (2%)
Pyrexia	0/53 (0%)		2/100 (2%)
Infections and infestations
Staphylococcal infection	1/53 (1.9%)		0/100 (0%)
Gastroenteritis	0/53 (0%)		2/100 (2%)
Nasopharyngitis	0/53 (0%)		2/100 (2%)
Injury, poisoning and procedural complications
Concussion	1/53 (1.9%)		1/100 (1%)
Joint sprain	0/53 (0%)		2/100 (2%)
Musculoskeletal and connective tissue disorders
Back pain	0/53 (0%)		2/100 (2%)
Nervous system disorders
Headache	3/53 (5.7%)		3/100 (3%)
Respiratory, thoracic and mediastinal disorders
Nasal congestion	2/53 (3.8%)		0/100 (0%)
Cough	1/53 (1.9%)		0/100 (0%)
Cough	1/53 (1.9%)		1/100 (1%)
Skin and subcutaneous tissue disorders
Pain of skin	0/53 (0%)		17/100 (17%)
Skin burning sensation	0/53 (0%)		15/100 (15%)
Pruritus	1/53 (1.9%)		8/100 (8%)
Erythema	0/53 (0%)		4/100 (4%)
Rash	1/53 (1.9%)		2/100 (2%)
Scab	0/53 (0%)		2/100 (2%)
Swelling face	1/53 (1.9%)		1/100 (1%)
Dermatitis	1/53 (1.9%)		0/100 (0%)
Skin hyperpigmentation	0/53 (0%)		2/100 (2%)
Blister	0/53 (0%)		1/100 (1%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.