Acne Vulgaris
Conditions
Keywords
Moderate to severe Acne Vulgaris
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.
Interventions
DRUGArea cleaned with saline water and occluded with Tegaderm
DRUGArea cleaned with saline water
DRUGArea cleaned with Ethyl alcohol solution
DRUGVisonac left on the skin for 24 hours in facial area one
DRUGVisonac wiped off after one hour
DRUGVisonac left on the skin 24 hours in facial area two
Sponsors
Photocure
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to 35 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
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
Participants by arm
| Arm | Count |
|---|---|
| 3 Areas Per Patient, 3 Hours | 12 |
| 3 Areas Per Patient, 24 Hours | 8 |
| Total | 20 |
Baseline characteristics
| Characteristic | 3 Areas Per Patient, 3 Hours | 3 Areas Per Patient, 24 Hours | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 7 Participants | 8 Participants | 15 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 5 Participants | 0 Participants | 5 Participants |
| Fluoresence intensity Alcohol wipe and Visonac without occlusion | 10.5 Fluoresence intensity unit FULL_RANGE 5 | NA Fluoresence intensity unit | 10.5 Fluoresence intensity unit |
| Fluoresence intensity Saline wipe and Visonac with occlusion | 11.2 Fluoresence intensity unit | NA Fluoresence intensity unit | 11.2 Fluoresence intensity unit |
| Fluoresence intensity Saline wipe and Visonac without occlusion | 10.8 Fluoresence intensity unit | NA Fluoresence intensity unit | 10.8 Fluoresence intensity unit |
| Fluoresence intensity Visonac left on skin for 1 hour | NA Fluoresence intensity unit | 9.3 Fluoresence intensity unit | 9.3 Fluoresence intensity unit |
| Fluoresence intensity Visonac left on skin for 24 hours, area 1 | NA Fluoresence intensity unit | 10.5 Fluoresence intensity unit | 10.5 Fluoresence intensity unit |
| Fluoresence intensity Visonac left on skin for 24 hours, area 2 | NA Fluoresence intensity unit | 10.6 Fluoresence intensity unit | 10.6 Fluoresence intensity unit |
| Region of Enrollment United States | 12 participants | 8 participants | 20 participants |
| Sex: Female, Male Female | 4 Participants | 3 Participants | 7 Participants |
| Sex: Female, Male Male | 8 Participants | 5 Participants | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 5 / 12 | 4 / 8 |
| serious Total, serious adverse events | 0 / 12 | 0 / 8 |
Outcome results
Primary
Photoactive Porphyrins Level
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
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Part 1: Area Cleaned With Saline and Occluded With Tegaderm | Photoactive Porphyrins Level | 35.3 Fluorescence intensity unit |
| Area Cleaned With Saline | Photoactive Porphyrins Level | 33.5 Fluorescence intensity unit |
| Area Cleaned With Ethyl Alcohol Solution | Photoactive Porphyrins Level | 37.3 Fluorescence intensity unit |
Primary
Photoactive Porphyrins Level
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
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Part 1: Area Cleaned With Saline and Occluded With Tegaderm | Photoactive Porphyrins Level | 21.6 Fluorescence intensity unit |
| Area Cleaned With Saline | Photoactive Porphyrins Level | 38.2 Fluorescence intensity unit |
| Area Cleaned With Ethyl Alcohol Solution | Photoactive Porphyrins Level | 44.3 Fluorescence intensity unit |
Primary
Photoactive Porphyrins Level
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
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Part 1: Area Cleaned With Saline and Occluded With Tegaderm | Photoactive Porphyrins Level | 16.8 Fluorescence intensity unit |
| Area Cleaned With Saline | Photoactive Porphyrins Level | 33.9 Fluorescence intensity unit |
| Area Cleaned With Ethyl Alcohol Solution | Photoactive Porphyrins Level | 38.1 Fluorescence intensity unit |
Primary
Photoactive Porphyrins Level
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
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Part 1: Area Cleaned With Saline and Occluded With Tegaderm | Photoactive Porphyrins Level | 13.1 Fluorescence intensity unit |
| Area Cleaned With Saline | Photoactive Porphyrins Level | 25.8 Fluorescence intensity unit |
| Area Cleaned With Ethyl Alcohol Solution | Photoactive Porphyrins Level | 25.9 Fluorescence intensity unit |
Primary
Photoactive Porphyrins Level
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
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Part 1: Area Cleaned With Saline and Occluded With Tegaderm | Photoactive Porphyrins Level | 59.3 Fluorescence intensity unit |
| Area Cleaned With Saline | Photoactive Porphyrins Level | 38.3 Fluorescence intensity unit |
| Area Cleaned With Ethyl Alcohol Solution | Photoactive Porphyrins Level | 30.1 Fluorescence intensity unit |
Primary
Photoactive Porphyrins Level
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
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Part 1: Area Cleaned With Saline and Occluded With Tegaderm | Photoactive Porphyrins Level | 33.0 Fluorescence intensity unit |
| Area Cleaned With Saline | Photoactive Porphyrins Level | 24.8 Fluorescence intensity unit |
| Area Cleaned With Ethyl Alcohol Solution | Photoactive Porphyrins Level | 19.7 Fluorescence intensity unit |