- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01347879
A Double Blinded, Prospective, Randomized, Vehicle Controlled Multi-center Study of Photodynamic Therapy With Visonac® Cream in Patients With Acne Vulgaris
December 2, 2013 updated by: Photocure
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
153
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
Oceanside, California, United States, 92056
- Dermatology Specialists Inc
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San Diego, California, United States, 92123
- Rady Children's Hospital
-
-
Florida
-
Jacksonville, Florida, United States, 32204
- North Florida Dermatology Associates
-
-
Illinois
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Arlington Heights, Illinois, United States, 60005
- Altman Dermatology Associates
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Naperville, Illinois, United States, 60563
- Dermatology Institute, DuPage Medical Group
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Indiana
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Evansville, Indiana, United States, 47713
- Deaconess Clinic Inc
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-
Massachusetts
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Haverhill, Massachusetts, United States, 10830
- ActivMed Practices & Research Inc
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Michigan
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Fort Gratiot, Michigan, United States, 48059
- Hamzavi Dermatology
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Troy, Michigan, United States, 48084
- Somerset Skin Centre
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Pennsylvania
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Hershey, Pennsylvania, United States, 17033
- Penn State Hershey Medical Center
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Rhode Island
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Johnston, Rhode Island, United States, 02919
- Clinical Partners LLC
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Texas
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Austin, Texas, United States, 78759
- DermResearch Inc
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San Antonio, Texas, United States, 78229
- Clinical Trials of Texas
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Virginia
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Norfolk, Virginia, United States, 23507
- Virginia Clinical Research, Inc.
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Washington
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Spokane, Washington, United States, 99216
- Premier Clinical Research
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
12 years to 35 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Visonac cream with PDT
active treatment with light dose of 37 Joule/cm2
|
cream application prior to illumination with red light
Other Names:
|
Placebo Comparator: Vehicle cream with PDT
Placebo treatment, Light dose 37 Joule/cm2
|
placebo/vehicle cream application prior to illumination with red light
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Absolute Change From Baseline in Facial Inflammatory Lesion Count (Nodules, Papules, and Pustules).
Time Frame: From baseline to 12 weeks after first treatment
|
From baseline to 12 weeks after first treatment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
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
|
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
|
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.
|
From baseline to 12 weeks after first treatment
|
Pain During Illumination.
Time Frame: Immediately after first treatment
|
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.
|
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
|
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
|
Clinical assessment using a 4 point scale; none, mild, moderate, severe
|
Immediately after first treatment
|
Clear and Almost Clear Scarring According to Scarring Score
Time Frame: at week 12 after first treatment
|
Clinical assessment using a 6 point scale; Clear, Almost clear, Mild, Moderate, Severe and Very severe
|
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
|
From baseline to 12 weeks after first treatment
|
|
Erythema Score of Severe
Time Frame: Immediately after first treatment
|
Clinical assessment using a 4 point scale; none, mild, moderate, severe
|
Immediately after first treatment
|
Erythema Score of Mild and Moderate
Time Frame: 2 days after first treatment
|
Clinical assessment using a 4 point scale; none, mild, moderate, severe
|
2 days after first treatment
|
Erythema Score of Severe
Time Frame: 2 days after first treatment
|
Clinical assessment using a 4 point scale; none, mild, moderate, severe
|
2 days after first treatment
|
Mild and Moderate Scarring According to Scarring Score
Time Frame: at week 12 after first treatment
|
Clinical assessment using a 6 point scale; Clear, Almost clear, Mild, Moderate, Severe and Very severe
|
at week 12 after first treatment
|
Severe and Very Severe Scarring According to Scarring Score
Time Frame: at week 12 after first treatment
|
Clinical assessment using a 6 point scale; Clear, Almost clear, Mild, Moderate, Severe and Very severe
|
at week 12 after first treatment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: David Pariser, MD, Virginia Clinical Research, Inc.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2011
Primary Completion (Actual)
April 1, 2012
Study Completion (Actual)
May 1, 2012
Study Registration Dates
First Submitted
May 3, 2011
First Submitted That Met QC Criteria
May 3, 2011
First Posted (Estimate)
May 4, 2011
Study Record Updates
Last Update Posted (Estimate)
January 16, 2014
Last Update Submitted That Met QC Criteria
December 2, 2013
Last Verified
December 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PCTA206/11
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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