Acne VulgarisPhase 2NCT01347879
A Double Blinded, Prospective, Randomized, Vehicle Controlled Multi-center Study of Photodynamic Therapy With Visonac® Cream in Patients With Acne Vulgaris
A Phase 2 study testing Visonac PDT in people with Acne Vulgaris, run by Photocure at 15 sites in United States.
Trial 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. 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?
- Visonac PDT
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 153 participants
- Where
- 15 sitesUnited States
- Study dates
- May 2011to May 2012
- 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
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
United States15 sites
Altman Dermatology Associates
Arlington Heights, Illinois, 60005
DermResearch Inc
Austin, Texas, 78759
Deaconess Clinic Inc
Evansville, Indiana, 47713
Hamzavi Dermatology
Fort Gratiot, Michigan, 48059
ActivMed Practices & Research Inc
Haverhill, Massachusetts, 10830
Penn State Hershey Medical Center
Hershey, Pennsylvania, 17033
North Florida Dermatology Associates
Jacksonville, Florida, 32204
Clinical Partners LLC
Johnston, Rhode Island, 02919
Dermatology Institute, DuPage Medical Group
Naperville, Illinois, 60563
Virginia Clinical Research, Inc.
Norfolk, Virginia, 23507
Dermatology Specialists Inc
Oceanside, California, 92056
Clinical Trials of Texas
San Antonio, Texas, 78229
Rady Children's Hospital
San Diego, California, 92123
Premier Clinical Research
Spokane, Washington, 99216
Somerset Skin Centre
Troy, Michigan, 48084
About this study
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.
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.
- Conditions
- Acne Vulgaris
- Being tested
- Visonac PDT, Vehicle cream with PDT
- Keywords
- Acne vulgaris, PDT
- 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 PDTDrug
Also called red light
cream application prior to illumination with red light
Vehicle cream with PDTDrug
Also called red light
placebo/vehicle cream application prior to illumination with red light
| Study group | Role | What they receive |
|---|---|---|
| Visonac cream with PDT | Experimental | active treatment with light dose of 37 Joule/cm2 Receives: Drug: Visonac PDT |
| Vehicle cream with PDT | Placebo comparator | Placebo treatment, Light dose 37 Joule/cm2 Receives: Drug: Vehicle cream with PDT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absolute Change From Baseline in Facial Inflammatory Lesion Count (Nodules, Papules, and Pustules).
Measured: From baseline to 12 weeks after first treatment
Secondary outcomes (13)
Absolute Change From Baseline in Facial Non-inflammatory Lesion Count (Open and Closed Comedones)
Measured: From baseline to 12 weeks after the first treatment
Percent Change From Baseline in Facial Inflammatory (Nodules, Papules, and Pustules)Lesion Counts.
Measured: From baseline to 12 weeks after the first treatment
Proportion of Patients With Success According to IGA Scale Based on the Facial Assessment.
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.
Measured: From baseline to 12 weeks after first treatment
Pain During Illumination.
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.
Measured: Immediately after first treatment
Number of Patients With Adverse Events.
Measured: From administration of investigational medicinal product (IMP) until 12 weeks after first IMP administration
Erythema Score of Mild and Moderate
Clinical assessment using a 4 point scale; none, mild, moderate, severe
Measured: Immediately after first treatment
Clear and Almost Clear Scarring According to Scarring Score
Clinical assessment using a 6 point scale; Clear, Almost clear, Mild, Moderate, Severe and Very severe
Measured: at week 12 after first treatment
Percent Change From Baseline in Facial Non-inflammatory Lesion Count (Open and Closed Comedones)
Measured: From baseline to 12 weeks after first treatment
Erythema Score of Severe
Clinical assessment using a 4 point scale; none, mild, moderate, severe
Measured: Immediately after first treatment
Erythema Score of Mild and Moderate
Clinical assessment using a 4 point scale; none, mild, moderate, severe
Measured: 2 days after first treatment
Erythema Score of Severe
Clinical assessment using a 4 point scale; none, mild, moderate, severe
Measured: 2 days after first treatment
Mild and Moderate Scarring According to Scarring Score
Clinical assessment using a 6 point scale; Clear, Almost clear, Mild, Moderate, Severe and Very severe
Measured: at week 12 after first treatment
Severe and Very Severe Scarring According to Scarring Score
Clinical assessment using a 6 point scale; Clear, Almost clear, Mild, Moderate, Severe and Very severe
Measured: at week 12 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 posted4 May 2011 (estimated)
- Study startMay 2011
- Primary completionApr 2012
- Study completionMay 2012
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
- 153 participants (actual)
Sponsor and investigators
- Lead sponsor
- Photocure
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David Pariser, MD, Principal investigator, Virginia Clinical Research, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01347879
- Sponsor's protocol ID
- PCTA206/11
- Status last verified
- Dec 2013
- First submitted
- 3 May 2011
- Last updated
- 16 Jan 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 16 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01347879
- Acronym / sponsor ID
- PCTA206/11
- Conditions
- Acne Vulgaris
- Keywords
- Acne vulgaris, PDT
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 153 participants (actual)
- Lead sponsor
- PhotocureIndustry (pharma, biotech, devices)
- Study start
- May 2011
- Primary completion
- Apr 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 4 May 2011 (estimated)
- Results
- Posted 16 Jan 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 PDTactive treatment with light dose of 37 Joule/cm2 |
| Vehicle cream with PDT | Placebo comparator | Drug: Vehicle cream with PDTPlacebo treatment, Light dose 37 Joule/cm2 |
Who may qualify
- Ages
- 12 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (22 listed)
- 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.
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 PDTAlso: red lightcream application prior to illumination with red light | Drug | Visonac cream with PDT |
| Vehicle cream with PDTAlso: red lightplacebo/vehicle cream application prior to illumination with red light | Drug | Vehicle cream with PDT |
Primary outcome
Absolute Change From Baseline in Facial Inflammatory Lesion Count (Nodules, Papules, and Pustules).
Time frame: From baseline to 12 weeks after first treatment
13 secondary outcomes
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
Percent Change From Baseline in Facial Inflammatory (Nodules, Papules, and Pustules)Lesion Counts.
Time frame: From baseline to 12 weeks after the first treatment
Proportion of Patients With Success According to IGA Scale Based on the Facial Assessment.
Time frame: From baseline to 12 weeks after first treatment
Pain During Illumination.
Time frame: Immediately after first treatment
Number of Patients With Adverse Events.
Time frame: From administration of investigational medicinal product (IMP) until 12 weeks after first IMP administration
Erythema Score of Mild and Moderate
Time frame: Immediately after first treatment
Clear and Almost Clear Scarring According to Scarring Score
Time frame: at week 12 after first treatment
Percent Change From Baseline in Facial Non-inflammatory Lesion Count (Open and Closed Comedones)
Time frame: From baseline to 12 weeks after first treatment
Erythema Score of Severe
Time frame: Immediately after first treatment
Erythema Score of Mild and Moderate
Time frame: 2 days after first treatment
Erythema Score of Severe
Time frame: 2 days after first treatment
Mild and Moderate Scarring According to Scarring Score
Time frame: at week 12 after first treatment
Severe and Very Severe Scarring According to Scarring Score
Time frame: at week 12 after first treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 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.
David Pariser, MD principal investigator
Virginia Clinical Research, Inc.
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Visonac PDT in people with Acne Vulgaris, run by Photocure at 15 sites 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 22 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 16 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites 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. 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 16 Jan 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?
Absolute Change From Baseline in Facial Inflammatory Lesion Count (Nodules, Papules, and Pustules). (time frame: From baseline to 12 weeks after first treatment). 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 16 Jan 2014.