Acne VulgarisPhase 2NCT01160848
Photoactive Porphyrins (PAP) Levels After Topical Visonac Application in Acne Patients
A Phase 2 study testing Area cleaned with saline water and occluded with Tegaderm, Area cleaned with saline water and Area cleaned with Ethyl alcohol solution in people with Acne Vulgaris, run by Photocure at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 35 years
- Conditions the study is for
- Acne Vulgaris
- What is being tested?
- Area cleaned with saline water and occluded with Tegaderm, Area cleaned with saline water and Area cleaned with Ethyl alcohol solution
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2010to Jan 2011
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 35 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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).
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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:
Read more
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.
- Conditions
- Acne Vulgaris
- Being tested
- Area cleaned with saline water and occluded with Tegaderm, Area cleaned with saline water, Area cleaned with Ethyl alcohol solution, Visonac left on the skin for 24 hours in facial area one, Visonac wiped off after one hour
- Keywords
- Moderate to severe Acne Vulgaris
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Area cleaned with saline water and occluded with TegadermDrug
Area cleaned with saline waterDrug
Area cleaned with Ethyl alcohol solutionDrug
Visonac left on the skin for 24 hours in facial area oneDrug
Visonac wiped off after one hourDrug
Visonac left on the skin 24 hours in facial area twoDrug
| Study group | Role | What they receive |
|---|---|---|
| Part 1 | Other | 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 Receives: Drug: Area cleaned with saline water and occluded with Tegaderm; Drug: Area cleaned with saline water; Drug: Area cleaned with Ethyl alcohol solution |
| Part 2 | Other | For each patient, 3 areas were randomized to treatment with Visonac for 24 hours (2 areas) or Visonac for 1 hour (1 area) Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Photoactive Porphyrins Level
Photoactive porphyrins levels on the skin surface of acne patients, part 1, measured by in vivo fluorescence spectroscopy
Measured: 1.5 hours after cream application
Photoactive Porphyrins Level
Photoactive porphyrins levels on the skin surface of acne patients, part 1, measured by in vivo fluorescence spectroscopy
Measured: 3 hours after cream application
Photoactive Porphyrins Level
Photoactive porphyrins levels on the skin surface of acne patients, part 2, measured by in vivo fluorescence spectroscopy
Measured: 3 hours after cream application
Photoactive Porphyrins Level
Photoactive porphyrins levels on the skin surface of acne patients, part 2, measured by in vivo fluorescence spectroscopy
Measured: 8 hours after cream application
Photoactive Porphyrins Level
Photoactive porphyrins levels on the skin surface of acne patients, part 2, measured by in vivo fluorescence spectroscopy
Measured: 12 hours after cream application
Photoactive Porphyrins Level
Photoactive porphyrins levels on the skin surface of acne patients, part 2, measured by in vivo fluorescence spectroscopy
Measured: 24 hours after cream application
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2010 (estimated)
- Study startAug 2010
- Primary completionJan 2011
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Acne VulgarisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Photocure
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael T. Jarratt, M.D., Principal investigator, Derm Research, PLLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01160848
- Sponsor's protocol ID
- PC TA205/10
- Status last verified
- Apr 2014
- First submitted
- 8 Jul 2010
- Last updated
- 20 May 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01160848
- Acronym / sponsor ID
- PC TA205/10
- Conditions
- Acne Vulgaris
- Keywords
- Moderate to severe Acne Vulgaris
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- PhotocureIndustry (pharma, biotech, devices)
- Study start
- Aug 2010
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 12 Jul 2010 (estimated)
- Results
- Posted 20 May 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part 1 | Other | Drug: Area cleaned with saline water and occluded with Tegaderm, Drug: Area cleaned with saline water, Drug: Area cleaned with Ethyl alcohol solutionThree 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 |
| Part 2 | Other | 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 twoFor each patient, 3 areas were randomized to treatment with Visonac for 24 hours (2 areas) or Visonac for 1 hour (1 area) |
Who may qualify
- Ages
- 12 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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).
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Area cleaned with saline water and occluded with Tegaderm | Drug | Part 1 |
| Area cleaned with saline water | Drug | Part 1 |
| Area cleaned with Ethyl alcohol solution | Drug | Part 1 |
| Visonac left on the skin for 24 hours in facial area one | Drug | Part 2 |
| Visonac wiped off after one hour | Drug | Part 2 |
| Visonac left on the skin 24 hours in facial area two | Drug | Part 2 |
Primary outcome
Photoactive Porphyrins Level
Time frame: 1.5 hours after cream application
Photoactive porphyrins levels on the skin surface of acne patients, part 1, measured by in vivo fluorescence spectroscopy
Photoactive Porphyrins Level
Time frame: 3 hours after cream application
Photoactive porphyrins levels on the skin surface of acne patients, part 1, measured by in vivo fluorescence spectroscopy
Photoactive Porphyrins Level
Time frame: 3 hours after cream application
Photoactive porphyrins levels on the skin surface of acne patients, part 2, measured by in vivo fluorescence spectroscopy
Photoactive Porphyrins Level
Time frame: 8 hours after cream application
Photoactive porphyrins levels on the skin surface of acne patients, part 2, measured by in vivo fluorescence spectroscopy
Photoactive Porphyrins Level
Time frame: 12 hours after cream application
Photoactive porphyrins levels on the skin surface of acne patients, part 2, measured by in vivo fluorescence spectroscopy
Photoactive Porphyrins Level
Time frame: 24 hours after cream application
Photoactive porphyrins levels on the skin surface of acne patients, part 2, measured by in vivo fluorescence spectroscopy
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael T. Jarratt, M.D. principal investigator
Derm Research, PLLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Area cleaned with saline water and occluded with Tegaderm, Area cleaned with saline water and Area cleaned with Ethyl alcohol solution in people with Acne Vulgaris, run by Photocure at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 May 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Photoactive Porphyrins Level (time frame: 1.5 hours after cream application). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2014.