A Double Blinded, Prospective, Randomized, Vehicle Controlled Multi-center Study of Photodynamic Therapy With Visonac® Cream in Patients With Acne Vulgaris
PCTA206/11 A Double Blinded, Prospective, Randomized, Vehicle Controlled Multi Center Study of Photodynamic Therapy With Visonac® Cream in Patients With Acne Vulgaris.
1 other identifier
interventional
153
1 country
15
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started May 2011
Shorter than P25 for phase_2
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2011
CompletedFirst Submitted
Initial submission to the registry
May 3, 2011
CompletedFirst Posted
Study publicly available on registry
May 4, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2012
CompletedResults Posted
Study results publicly available
January 16, 2014
CompletedJanuary 16, 2014
December 1, 2013
11 months
May 3, 2011
September 23, 2013
December 2, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Absolute Change From Baseline in Facial Inflammatory Lesion Count (Nodules, Papules, and Pustules).
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)
From baseline to 12 weeks after the first treatment
Percent Change From Baseline in Facial Inflammatory (Nodules, Papules, and Pustules)Lesion Counts.
From baseline to 12 weeks after the first treatment
Proportion of Patients With Success According to IGA Scale Based on the Facial Assessment.
From baseline to 12 weeks after first treatment
Pain During Illumination.
Immediately after first treatment
Number of Patients With Adverse Events.
From administration of investigational medicinal product (IMP) until 12 weeks after first IMP administration
- +8 more secondary outcomes
Study Arms (2)
Visonac cream with PDT
EXPERIMENTALactive treatment with light dose of 37 Joule/cm2
Vehicle cream with PDT
PLACEBO COMPARATORPlacebo treatment, Light dose 37 Joule/cm2
Interventions
cream application prior to illumination with red light
placebo/vehicle cream application prior to illumination with red light
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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).
- 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.
- +6 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Photocurelead
Study Sites (15)
Dermatology Specialists Inc
Oceanside, California, 92056, United States
Rady Children's Hospital
San Diego, California, 92123, United States
North Florida Dermatology Associates
Jacksonville, Florida, 32204, United States
Altman Dermatology Associates
Arlington Heights, Illinois, 60005, United States
Dermatology Institute, DuPage Medical Group
Naperville, Illinois, 60563, United States
Deaconess Clinic Inc
Evansville, Indiana, 47713, United States
ActivMed Practices & Research Inc
Haverhill, Massachusetts, 10830, United States
Hamzavi Dermatology
Fort Gratiot, Michigan, 48059, United States
Somerset Skin Centre
Troy, Michigan, 48084, United States
Penn State Hershey Medical Center
Hershey, Pennsylvania, 17033, United States
Clinical Partners LLC
Johnston, Rhode Island, 02919, United States
DermResearch Inc
Austin, Texas, 78759, United States
Clinical Trials of Texas
San Antonio, Texas, 78229, United States
Virginia Clinical Research, Inc.
Norfolk, Virginia, 23507, United States
Premier Clinical Research
Spokane, Washington, 99216, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr David Pariser
- Organization
- Virginia Clinical Research, Inc.
Study Officials
- PRINCIPAL INVESTIGATOR
David Pariser, MD
Virginia Clinical Research, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 3, 2011
First Posted
May 4, 2011
Study Start
May 1, 2011
Primary Completion
April 1, 2012
Study Completion
May 1, 2012
Last Updated
January 16, 2014
Results First Posted
January 16, 2014
Record last verified: 2013-12