Photoactive Porphyrins (PAP) Levels After Topical Visonac Application in Acne Patients

• Sponsor: Photocure (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01160848
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Arms: 2
• Duration (Months): 5
• Patients Per Site Per Month: 4

Study Details

Study Description

Brief Summary

Open, prospective, randomized, single-centre study in patients with moderate to severe facial acne vulgaris. Three circular areas with a diameter of 4 cm, each circle including at least 4 inflammatory lesions, will be selected in acne-affected areas in the face. One area should be identified on each cheek and one area should be identified on the forehead. The minimum distance between the three areas should be at least 4 cm. For each patient the three areas will be randomized to either a pre-treatment cleaning using a wipe containing an ethyl alcohol solution(one area) or a cleansing wipe containing saline water (two areas), before application of the Visonac cream. One of the areas cleaned with saline wipe will also be occluded with a transparent dressing (Tegaderm) during the incubation time. In vivo fluorescence spectroscopy will be performed in the three areas before cream application, and at 1h, 1.5h, 2h, 2.5h and 3 h after cream application. After the last fluorescence spectroscopy reading, the cream should be wiped off and the patient should protect the three areas from sunlight, prolonged, or intense light for 2 days.

The study was extended with additionally 8 patients to explore the photoactive porphyrin levels over a 24 hour period:

The patients will clean their face with Cetaphil Gentle Skin Cleanser before cream application. For each patient the three areas will be randomized to Visonac 80mg left on the skin for 24 hours and Visonac (MAL8%) to be wiped of after 1 hour.

In vivo fluorescence spectroscopy will be performed at all three areas before cream application, and at 2h, 3 h, 4h, 5h, 8h, 10h, 11h, 12h, 13h, 15 and 24h after cream application. The exact time points may be adjusted based on the result from the previously included patients. All patients will be instructed to protect the three areas from sunlight, prolonged, or intense light for 2 days.

Condition or Disease	Intervention/Treatment	Phase
Acne Vulgaris	Drug: Area cleaned with saline water and occluded with Tegaderm; Drug: Area cleaned with saline water; Drug: Area cleaned with Ethyl alcohol solution; Drug: Visonac left on the skin for 24 hours in facial area one; Drug: Visonac wiped off after one hour; Drug: Visonac left on the skin 24 hours in facial area two	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 20 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Official Title: A Clinical Study of Photoactive Porphyrins (PAP) Levels in Acne-affected Skin After Topical Visonac Application in Patients With Moderate to Severe Facial Acne Vulgaris
• Study Start Date: Aug 1, 2010
• Actual Primary Completion Date: Jan 1, 2011
• Actual Study Completion Date: Jan 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Other: Part 1 Three areas will be randomized to either a pre-treatment cleaning using a wipe containing an ethyl alcohol solution(one area) or a cleansing wipe containing saline water (two areas), before application of the Visonac cream. One of the areas cleaned with saline wipe will also be occluded with a transparent dressing (Tegaderm) during the incubation time. In vivo fluorescence spectroscopy will be performed in the three areas before cream application, and at 1h, 1.5h, 2h, 2.5h and 3 h after cream application	Drug: Area cleaned with saline water and occluded with Tegaderm; Drug: Area cleaned with saline water; Drug: Area cleaned with Ethyl alcohol solution
Other: Part 2 For each patient, 3 areas were randomized to treatment with Visonac for 24 hours (2 areas) or Visonac for 1 hour (1 area)	Drug: Visonac left on the skin for 24 hours in facial area one; Drug: Visonac wiped off after one hour; Drug: Visonac left on the skin 24 hours in facial area two

Outcome Measures

Primary Outcome Measures

1. Photoactive Porphyrins Level [1.5 hours after cream application]

   Photoactive porphyrins levels on the skin surface of acne patients, part 1, measured by in vivo fluorescence spectroscopy

2. Photoactive Porphyrins Level [3 hours after cream application]

   Photoactive porphyrins levels on the skin surface of acne patients, part 1, measured by in vivo fluorescence spectroscopy

3. Photoactive Porphyrins Level [3 hours after cream application]

   Photoactive porphyrins levels on the skin surface of acne patients, part 2, measured by in vivo fluorescence spectroscopy

4. Photoactive Porphyrins Level [8 hours after cream application]

   Photoactive porphyrins levels on the skin surface of acne patients, part 2, measured by in vivo fluorescence spectroscopy

5. Photoactive Porphyrins Level [12 hours after cream application]

   Photoactive porphyrins levels on the skin surface of acne patients, part 2, measured by in vivo fluorescence spectroscopy

6. Photoactive Porphyrins Level [24 hours after cream application]

   Photoactive porphyrins levels on the skin surface of acne patients, part 2, measured by in vivo fluorescence spectroscopy

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• Signed and verified informed consent form. For patients under age of 18, an assent form in conjunction with an informed consent form, signed and verified by parent/guardian.

• Adolescent and adult female and male patients, from 12 to 35 years of age.

• Patients with moderate to severe facial acne vulgaris according to the IGA scale.

• 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 the study visit.

• Patients with skin type II to III (Fitzpatrick).

• Patients with 3 areas of 4 cm in diameter, each including at least with at least 4 inflammatory lesions (papules, pustules, and nodules) in the face (at cheek and forehead).

Exclusion Criteria:

• Subject is the investigator or any sub investigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the protocol.

• 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 subjects with childbearing potential (i.e. ovulation, pre-menopausal, not surgically sterilized) not willing to use a medically accepted contraceptive regimen while on treatment.

• Pregnancy

• Lactating.

• Participation in other clinical studies either currently or within the last 30 days.

• Patients with porphyria.

• Known allergy to (MAL), to a similar PDT compound, or to excipients of the cream

• Patients with cutaneous photosensitivity.

• Patients that have received topical treatments for their acne within the last 14 days. Medicated cleansers not containing active ingredients such as 5% BPO or high concentration of salicylic acid may be stopped before the treatment. (Cosmetic Cleansers that contains no more than 2 % salicylic acid is allowed).

• Patients that has received oral antibiotics for treatment of their acne within the last month.

• Patients that has received oral isotretinoin within the last 6 months.

• Patients with a beard that might interfere with study assessments.

• Patients with melanoma or dysplastic nevi in the treatment area

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	DermResearch, Inc.	Austin	Texas	United States	78759

Sponsors and Collaborators

• Photocure

Investigators

• Principal Investigator: Michael T. Jarratt, M.D., Derm Research, PLLC

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Photocure
• ClinicalTrials.gov Identifier: NCT01160848
• Other Study ID Numbers: PC TA205/10
• First Posted: Jul 12, 2010
• Last Update Posted: May 20, 2014
• Last Verified: Apr 1, 2014

• Keywords provided by Photocure: Moderate to severe Acne Vulgaris
• Additional relevant MeSH terms: Acne Vulgaris; Ethanol

Study Results

Participant Flow

Recruitment Details	The study was conducted in one center in the US: Michael Jarratt M.D. DermResearch Inc. 8140 N Mopac Building 3, Suite 120 Austin, TX 78759. First patient entered the study on the 8th of November 2010 Last patient last visit on the 9th January 2011

Arm/Group Title	3 Areas Per Patient, 3 Hours	3 Areas Per Patient, 24 Hours
Arm/Group Description	Visonac : MAL 80 mg/g Group 1: Alcohol wipe and Visonac without occlusion Group 2: Saline wipe and Visonac with occlusion Group 3: Saline wipe and Visonac without occlusion	Group 1: Visonac left on skin for 1 hour Group 2: Visonac left on skin for 24 hours, area 1 Group 3: Visonac left on skin for 24 hours, area 2
Period Title: Overall Study
STARTED	12	8
COMPLETED	12	8
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	3 Areas Per Patient, 3 Hours	3 Areas Per Patient, 24 Hours	Total
Arm/Group Description	Total of all reporting groups
Overall Participants	12	8	20
Age (Count of Participants)
<=18 years	7 58.3%	8 100%	15 75%
Between 18 and 65 years	5 41.7%	0 0%	5 25%
>=65 years	0 0%	0 0%	0 0%
Sex: Female, Male (Count of Participants)
Female	4 33.3%	3 37.5%	7 35%
Male	8 66.7%	5 62.5%	13 65%
Region of Enrollment (participants) [Number]
United States	12 100%	8 100%	20 100%
Fluoresence intensity (Fluoresence intensity unit) [Mean (Full Range) ]
Alcohol wipe and Visonac without occlusion	10.5 (5.0)	NA	10.5
Saline wipe and Visonac with occlusion	11.2	NA	11.2
Saline wipe and Visonac without occlusion	10.8	NA	10.8
Visonac left on skin for 1 hour	NA	9.3	9.3
Visonac left on skin for 24 hours, area 1	NA	10.5	10.5
Visonac left on skin for 24 hours, area 2	NA	10.6	10.6

Outcome Measures

1. Primary Outcome

Title	Photoactive Porphyrins Level
Description	Photoactive porphyrins levels on the skin surface of acne patients, part 1, measured by in vivo fluorescence spectroscopy
Time Frame	1.5 hours after cream application

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Part 1: Area Cleaned With Saline and Occluded With Tegaderm	Area Cleaned With Saline	Area Cleaned With Ethyl Alcohol Solution
Arm/Group Description
Measure Participants	12	12	12
Mean (95% Confidence Interval) [Fluorescence intensity unit]	33.0	24.8	19.7

2. Primary Outcome

Title	Photoactive Porphyrins Level
Description	Photoactive porphyrins levels on the skin surface of acne patients, part 1, measured by in vivo fluorescence spectroscopy
Time Frame	3 hours after cream application

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Part 1: Area Cleaned With Saline and Occluded With Tegaderm	Area Cleaned With Saline	Area Cleaned With Ethyl Alcohol Solution
Arm/Group Description
Measure Participants	12	12	12
Mean (95% Confidence Interval) [Fluorescence intensity unit]	59.3	38.3	30.1

3. Primary Outcome

Title	Photoactive Porphyrins Level
Description	Photoactive porphyrins levels on the skin surface of acne patients, part 2, measured by in vivo fluorescence spectroscopy
Time Frame	3 hours after cream application

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Visonac Wiped Off After 1 Hour	Visonac Left on Skin for 24 Hours in Area 1	Visonac Left on Skin for 24 Hours in Area 2
Arm/Group Description
Measure Participants	8	8	8
Mean (95% Confidence Interval) [Fluorescence intensity unit]	35.3	33.5	37.3

4. Primary Outcome

Title	Photoactive Porphyrins Level
Description	Photoactive porphyrins levels on the skin surface of acne patients, part 2, measured by in vivo fluorescence spectroscopy
Time Frame	8 hours after cream application

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Visonac Wiped Off After 1 Hour	Visonac Left on Skin for 24 Hours in Area 1	Visonac Left on Skin for 24 Hours in Area 2
Arm/Group Description
Measure Participants	8	8	8
Mean (95% Confidence Interval) [Fluorescence intensity unit]	21.6	38.2	44.3

5. Primary Outcome

Title	Photoactive Porphyrins Level
Description	Photoactive porphyrins levels on the skin surface of acne patients, part 2, measured by in vivo fluorescence spectroscopy
Time Frame	12 hours after cream application

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Visonac Wiped Off After 1 Hour	Visonac Left on Skin for 24 Hours in Area 1	Visonac Left on Skin for 24 Hours in Area 2
Arm/Group Description
Measure Participants	8	8	8
Mean (95% Confidence Interval) [Fluorescence intensity unit]	16.8	33.9	38.1

6. Primary Outcome

Title	Photoactive Porphyrins Level
Description	Photoactive porphyrins levels on the skin surface of acne patients, part 2, measured by in vivo fluorescence spectroscopy
Time Frame	24 hours after cream application

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Visonac Wiped Off After 1 Hour	Visonac Left on Skin for 24 Hours in Area 1	Visonac Left on Skin for 24 Hours in Area 2
Arm/Group Description
Measure Participants	8	8	8
Mean (95% Confidence Interval) [Fluorescence intensity unit]	13.1	25.8	25.9

Adverse Events

Arm/Group Title	3 Areas Per Patient, 3 Hours		3 Areas Per Patient, 24 Hours
Arm/Group Description
All Cause Mortality
	3 Areas Per Patient, 3 Hours		3 Areas Per Patient, 24 Hours
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	3 Areas Per Patient, 3 Hours		3 Areas Per Patient, 24 Hours
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/12 (0%)		0/8 (0%)
Other (Not Including Serious) Adverse Events
	3 Areas Per Patient, 3 Hours		3 Areas Per Patient, 24 Hours
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	5/12 (41.7%)		4/8 (50%)
Skin and subcutaneous tissue disorders
Itching	3/12 (25%)	3	4/8 (50%)	4
Erythema	4/12 (33.3%)	5	2/8 (25%)	4
Increased number of pimples	1/12 (8.3%)	1	1/8 (12.5%)	1
Burning	0/12 (0%)	0	1/8 (12.5%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.