Acne VulgarisPhase 2NCT00933543
Efficacy and Safety Study With Visonac Photodynamic Therapy (PDT)
A Phase 2 study testing Visonac PDT (MAL PDT) and PDT in people with Acne Vulgaris, run by Photocure at 11 sites in 2 countries.
Trial summary
The purpose of this trial is to study the efficacy and safety of Visonac PDT in patients from 9 to 35 years old with Aktilite® CL512. Patients was randomized to Visonac or vehicle cream without occlusion and red light(dose: 37J/cm2) Read more about this study
- Who is it for?
- Ages 9 to 35 years
- Conditions the study is for
- Acne Vulgaris
- What is being tested?
- Visonac PDT (MAL PDT) and PDT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 107 participants
- Where
- 11 sitesin 2 countries
- Study dates
- Aug 2009to Mar 2010
- 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 9 to 35 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Female and male patients, above 9 years of age with moderate to severe facial acne vulgaris (IGA score 3-4).
- 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 6 months and must agree to stay with the same product and dose for an additional 6 months.
- Fitzpatrick skin type I through VI.
- Patients with 20 to 100 inflammatory lesions (papules, pustules, and nodules) on the face.
- Patients with 30 to 120 non-inflammatory lesions (open and closed comedones) on the face.
- Patients with no more than 2 nodular lesions on the face.
- Signed and verified informed consent form. For subjects under age of 18, an assent form in conjunction with an informed consent form, signed and verified by parent/guardian.
Who cannot join
- Patients presenting with any of the following will not be included in the study:
- 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 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 patients using oral contraceptives, that have not used the same product or dose within the last 6 months and do not agree to stay with the same product and dose for the duration of the study.
- Pregnancy
- Patients undergoing testosterone or any other systemic hormonal treatment.
Show all 18Show fewer
- Patients using hormonal contraceptives solely for the control of acne.
- Known allergy to MAL, to a similar PDT compound, or to excipients of the cream.
- Patients with porphyria.
- Patients with cutaneous photosensitivity.
- Participation in other clinical studies either concurrently or within the last 30 days, before T1.
- Patients with a washout period for topical treatments e.g., topical BPOs, retinoids and antibiotics, for their acne of less than 14 days, before T1. Medicated cleansers may be used during the washout period and stopped before the treatment.
- Patients with a washout period for oral antibiotics for treatment of their acne of less than 1 month, before T1.
- Patients with a washout period for oral isotretinoin of less than 6 months, before T1.
- Patients with a beard or other facial hair 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.
Trial locations and contacts
11 sites in 2 countries.
11 sites in 2 countries
United States8 sites
DeNova Research
Chicago, Illinois, 60611
Minnesota Clinical Study Center
Fridley, Minnesota, 55432
Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033
Madison Skin & Research, Inc
Madison, Wisconsin, 53719
Dermatology Institute of DuPage Medical Group
Naperville, Illinois, 60563
Virginia Clinical Research, Inc.
Norfolk, Virginia, 23507
Dermatology Associates of Rochester
Rochester, New York, 14623
Children's Specialists of San Diego / Rady Children's Hospital San Diego
San Diego, California, 92123
Canada3 sites
INNOVADERM Research Inc.
Montreal, Quebec
Centre de Recherche Dermatologique
Québec, Quebec, 2880
Windsor Clinical Research, Inc.
Windsor, Ontario N8W 5L7, Ontario, N8W 5L7
About this study
Official title: A Double Blinded, Prospective, Randomized, Stratified, Placebo-controlled, Multi-center Study of Photodynamic Therapy With VisonacTM Cream in Patients With Moderate to Severe Acne Vulgaris.
The purpose of this trial is to study the efficacy and safety of Visonac PDT in patients from 9 to 35 years old with Aktilite® CL512. Patients was randomized to Visonac or vehicle cream without occlusion and red light(dose: 37J/cm2)
Read the detailed description
Double blinded, prospective, randomized, stratified, placebo-controlled, multi-center study in patients with moderate to severe acne vulgaris. Patients with facial severity grades 3 to 4 on the Investigator's Global Assessment (IGA) scale will be included. Each patient will be classified according to age in the two age groups 9 to 12 years and 13 to 35 years and randomized to either Visonac or vehicle cream within each age group. All patients will receive 4 treatments 2 weeks apart (at week 0, 2 ,4 and 6 week). Efficacy evaluation will be done after each treatment and at 12 weeks after the first treatment. Safety evaluations will be performed at each treatment visit and at 12 weeks after the first treatment.
Photographs of patients will be taken before and after treatment at first and last treatment visit, and at 12 weeks after first treatment.
Blood samples will be drawn at 3 visits; pre-treatment visit, one week after first treatment and at one week after last treatment visit.
- Conditions
- Acne Vulgaris
- Being tested
- Visonac PDT (MAL PDT), Vehicle cream (placebo), PDT
- Keywords
- Acne Vulgaris, Moderate to severe
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Visonac PDT (MAL PDT)Drug
Also called Visonac, MAL PDT, red light
Cream application followed by illumination with red light.
Vehicle cream (placebo)Drug
Also called Vehicle cream, MAL PDT, red light
Cream application followed by illumination with red light.
PDTProcedure or surgery
Also called Red light
Photodynamic Therapy - Light dose 37 J/cm2
| Study group | Role | What they receive |
|---|---|---|
| Visonac cream with PDT | Experimental | Active treatment, Light dose 37 J/cm2. Receives: Drug: Visonac PDT (MAL PDT); Procedure: PDT |
| Vehicle cream with PDT | Placebo comparator | Placebo treatment, Light dose 37 J/cm2. Receives: Drug: Vehicle cream (placebo); Procedure: PDT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks after the first treatment
Absolute Change From Baseline in Facial Inflammatory Lesion Count (Nodules, Papules, and Pustules)
Measured: 12 weeks after the first treatment
Absolute Change From Baseline in Facial Non Inflammatory Lesion Count
Measured: 12 weeks after first treatment
Secondary outcomes (23)
Percent Change From Baseline in Facial Inflammatory (Nodules, Papules, and Pustules)Lesion Count
Measured: 6 weeks after the first treatment
Percent Change From Baseline in Facial Inflammatory (Nodules, Papules, and Pustules)Lesion Count
Measured: 12 weeks after the first treatment
Percent Change From Baseline in Facial Non Inflammatory Lesion Count
Measured: 6 weeks after first treatment
Percent Change From Baseline in Facial Non Inflammatory Lesion Count
Measured: 12 weeks after first treatment
Percent Change From Baseline in Facial Total Lesion Count
Measured: 6 weeks after the first treatment
Percent Change From Baseline in Facial Total Lesion Count
Measured: 12 weeks after the first treatment
Proportion of Patients With a Reduction of at Least 50% From Baseline in Facial Non-inflammatory Lesion Count
Measured: 12 weeks after last treatment
Proportion of Patients With a Reduction of at Least 50% From Baseline in Facial Inflammatory Lesion Count From Baseline
Measured: 12 weeks after first treatment
Absolute Change From Baseline in Facial Inflammatory Lesion Count
Measured: 6 weeks after the first treatment
Absolute Change From Baseline in Facial Non- Inflammatory Lesion Count
Measured: 6 weeks after the first treatment
Absolute Change From Baseline in Facial Total Lesion Count
Measured: 6 weeks after the first treatment
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.
Measured: 6 weeks after the first treatment
Facial Pain Assessed Using a Visual Analogue Scale From 0 to 10, Where 0 Indicates no Pain and 10 Indicates Worst Pain Imaginable
Facial pain was assessed on a visual analogue scale ranging from 0-10cm.
Measured: directly after first treatment
Facial Pain Assessed Using a Visual Analogue Scale From 0 to 10, Where 0 Indicates no Pain and 10 Indicates Worst Pain Imaginable
Facial pain was assessed on a visual analogue scale ranging from 0-10cm.
Measured: directly after second treatment
Facial Pain Assessed Using a Visual Analogue Scale From 0 to 10, Where 0 Indicates no Pain and 10 Indicates Worst Pain Imaginable
Facial pain was assessed on a visual analogue scale ranging from 0-10cm.
Measured: directly after third treatment
Facial Pain Assessed Using a Visual Analogue Scale From 0 to 10, Where 0 Indicates no Pain and 10 Indicates Worst Pain Imaginable
Facial pain was assessed on a visual analogue scale ranging from 0-10cm.
Measured: directly after fourth treatment
Proportion of Patients With Mild and Moderate Hyperpigmentation
Measured: at 12 weeks after first treatment
Proportion of Patients With Severe Hyperpigmentation
Measured: at 12 weeks after first treatment
Proportion of Patients With Mild or Moderate Scarring at End of Study
Measured: week 12
Proportion of Patients With Clear or Almost Clear Scarring at End of Study
Measured: week 12
Proportion of Patients With Severe and Very Severe Scarring at End of Study
Measured: week 12
Proportion of Patients With Hypopigmentation (Mild Moderate, Severe)
Measured: at 12 weeks after first treatment
Proportion of Patients With Dryness (Mild)
Measured: at 12 weeks after first treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2009 (estimated)
- Study startAug 2009
- Primary completionMar 2010
- Study completionMar 2010
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 107 participants (actual)
Sponsor and investigators
- Lead sponsor
- Photocure
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lawrence F. Eichenfield, M.D, Principal investigator, Children's Specialists of San Diego / Rady Children's Hospital San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00933543
- Sponsor's protocol ID
- PC TA204/09
- Status last verified
- Nov 2013
- First submitted
- 2 Jul 2009
- Last updated
- 11 Dec 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double Blinded, Prospective, Randomized, Stratified, Placebo-controlled, Multi-center Study of Photodynamic Therapy With VisonacTM Cream in Patients With Moderate to Severe Acne Vulgaris.
- ClinicalTrials.gov ID
- NCT00933543
- Acronym / sponsor ID
- PC TA204/09
- Conditions
- Acne Vulgaris
- Keywords
- Acne Vulgaris, Moderate to severe
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 107 participants (actual)
- Lead sponsor
- PhotocureIndustry (pharma, biotech, devices)
- Study start
- Aug 2009
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 7 Jul 2009 (estimated)
- Results
- Posted 15 Nov 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this trial is to study the efficacy and safety of Visonac PDT in patients from 9 to 35 years old with Aktilite® CL512. Patients was randomized to Visonac or vehicle cream without occlusion and red light(dose: 37J/cm2)
Detailed description
Double blinded, prospective, randomized, stratified, placebo-controlled, multi-center study in patients with moderate to severe acne vulgaris. Patients with facial severity grades 3 to 4 on the Investigator's Global Assessment (IGA) scale will be included. Each patient will be classified according to age in the two age groups 9 to 12 years and 13 to 35 years and randomized to either Visonac or vehicle cream within each age group. All patients will receive 4 treatments 2 weeks apart (at week 0, 2 ,4 and 6 week). Efficacy evaluation will be done after each treatment and at 12 weeks after the first treatment. Safety evaluations will be performed at each treatment visit and at 12 weeks after the first treatment.
Photographs of patients will be taken before and after treatment at first and last treatment visit, and at 12 weeks after first treatment.
Blood samples will be drawn at 3 visits; pre-treatment visit, one week after first treatment and at one week after last treatment visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Visonac cream with PDT | Experimental | Drug: Visonac PDT (MAL PDT), Procedure: PDTActive treatment, Light dose 37 J/cm2. |
| Vehicle cream with PDT | Placebo comparator | Drug: Vehicle cream (placebo), Procedure: PDTPlacebo treatment, Light dose 37 J/cm2. |
Who may qualify
- Ages
- 9 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- Female and male patients, above 9 years of age with moderate to severe facial acne vulgaris (IGA score 3-4).
- 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 6 months and must agree to stay with the same product and dose for an additional 6 months.
- Fitzpatrick skin type I through VI.
- Patients with 20 to 100 inflammatory lesions (papules, pustules, and nodules) on the face.
- Patients with 30 to 120 non-inflammatory lesions (open and closed comedones) on the face.
Key exclusion criteria (18 listed)
- 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 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 patients using oral contraceptives, that have not used the same product or dose within the last 6 months and do not agree to stay with the same product and dose for the duration of the study.
- Pregnancy
- Patients undergoing testosterone or any other systemic hormonal treatment.
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 |
|---|---|---|
| Visonac PDT (MAL PDT)Also: Visonac, MAL PDT, red lightCream application followed by illumination with red light. | Drug | Visonac cream with PDT |
| Vehicle cream (placebo)Also: Vehicle cream, MAL PDT, red lightCream application followed by illumination with red light. | Drug | Vehicle cream with PDT |
| PDTAlso: Red lightPhotodynamic Therapy - Light dose 37 J/cm2 | Procedure or surgery | Vehicle cream with PDT, Visonac cream with PDT |
Primary outcome
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.
Time frame: 12 weeks after the first treatment
Absolute Change From Baseline in Facial Inflammatory Lesion Count (Nodules, Papules, and Pustules)
Time frame: 12 weeks after the first treatment
Absolute Change From Baseline in Facial Non Inflammatory Lesion Count
Time frame: 12 weeks after first treatment
23 secondary outcomes
Percent Change From Baseline in Facial Inflammatory (Nodules, Papules, and Pustules)Lesion Count
Time frame: 6 weeks after the first treatment
Percent Change From Baseline in Facial Inflammatory (Nodules, Papules, and Pustules)Lesion Count
Time frame: 12 weeks after the first treatment
Percent Change From Baseline in Facial Non Inflammatory Lesion Count
Time frame: 6 weeks after first treatment
Percent Change From Baseline in Facial Non Inflammatory Lesion Count
Time frame: 12 weeks after first treatment
Percent Change From Baseline in Facial Total Lesion Count
Time frame: 6 weeks after the first treatment
Percent Change From Baseline in Facial Total Lesion Count
Time frame: 12 weeks after the first treatment
Proportion of Patients With a Reduction of at Least 50% From Baseline in Facial Non-inflammatory Lesion Count
Time frame: 12 weeks after last treatment
Proportion of Patients With a Reduction of at Least 50% From Baseline in Facial Inflammatory Lesion Count From Baseline
Time frame: 12 weeks after first treatment
Absolute Change From Baseline in Facial Inflammatory Lesion Count
Time frame: 6 weeks after the first treatment
Absolute Change From Baseline in Facial Non- Inflammatory Lesion Count
Time frame: 6 weeks after the first treatment
Absolute Change From Baseline in Facial Total Lesion Count
Time frame: 6 weeks after the first treatment
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.
Time frame: 6 weeks after the first treatment
Facial Pain Assessed Using a Visual Analogue Scale From 0 to 10, Where 0 Indicates no Pain and 10 Indicates Worst Pain Imaginable
Time frame: directly after first treatment
Facial Pain Assessed Using a Visual Analogue Scale From 0 to 10, Where 0 Indicates no Pain and 10 Indicates Worst Pain Imaginable
Time frame: directly after second treatment
Facial Pain Assessed Using a Visual Analogue Scale From 0 to 10, Where 0 Indicates no Pain and 10 Indicates Worst Pain Imaginable
Time frame: directly after third treatment
Facial Pain Assessed Using a Visual Analogue Scale From 0 to 10, Where 0 Indicates no Pain and 10 Indicates Worst Pain Imaginable
Time frame: directly after fourth treatment
Proportion of Patients With Mild and Moderate Hyperpigmentation
Time frame: at 12 weeks after first treatment
Proportion of Patients With Severe Hyperpigmentation
Time frame: at 12 weeks after first treatment
Proportion of Patients With Mild or Moderate Scarring at End of Study
Time frame: week 12
Proportion of Patients With Clear or Almost Clear Scarring at End of Study
Time frame: week 12
Proportion of Patients With Severe and Very Severe Scarring at End of Study
Time frame: week 12
Proportion of Patients With Hypopigmentation (Mild Moderate, Severe)
Time frame: at 12 weeks after first treatment
Proportion of Patients With Dryness (Mild)
Time frame: at 12 weeks after first treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2013.
- 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.
Lawrence F. Eichenfield, M.D principal investigator
Children's Specialists of San Diego / Rady Children's Hospital San Diego
11 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Visonac PDT (MAL PDT) and PDT in people with Acne Vulgaris, run by Photocure at 11 sites in 2 countries.
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 7 inclusion and 18 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 11 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States, Canada. 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. Some participants in this study may receive a placebo. 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 15 Nov 2013). 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?
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. (time frame: 12 weeks after the first treatment). The study lists 3 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 11 Dec 2013.