Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

A Double Blinded, Prospective, Randomized, Vehicle Controlled Multi-center Study of Photodynamic Therapy With Visonac® Cream in Patients With Acne Vulgaris

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
PhotoCure
ClinicalTrials.gov Identifier:
NCT01347879
First received: May 3, 2011
Last updated: December 2, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention Phase
Acne Vulgaris
Drug: Visonac PDT
Drug: Vehicle cream with PDT
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by PhotoCure:

Primary Outcome Measures:
  • Absolute Change From Baseline in Facial Inflammatory Lesion Count (Nodules, Papules, and Pustules). [ Time Frame: From baseline to 12 weeks after first treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • Percent Change From Baseline in Facial Inflammatory (Nodules, Papules, and Pustules)Lesion Counts. [ Time Frame: From baseline to 12 weeks after the first treatment ] [ Designated as safety issue: No ]
  • Proportion of Patients With Success According to IGA Scale Based on the Facial Assessment. [ Time Frame: From baseline to 12 weeks after first treatment ] [ Designated as safety issue: No ]
    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.

  • Pain During Illumination. [ Time Frame: Immediately after first treatment ] [ Designated as safety issue: Yes ]
    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.

  • Number of Patients With Adverse Events. [ Time Frame: From administration of investigational medicinal product (IMP) until 12 weeks after first IMP administration ] [ Designated as safety issue: Yes ]
  • Erythema Score of Mild and Moderate [ Time Frame: Immediately after first treatment ] [ Designated as safety issue: Yes ]
    Clinical assessment using a 4 point scale; none, mild, moderate, severe

  • Clear and Almost Clear Scarring According to Scarring Score [ Time Frame: at week 12 after first treatment ] [ Designated as safety issue: No ]
    Clinical assessment using a 6 point scale; Clear, Almost clear, Mild, Moderate, Severe and Very severe

  • Percent Change From Baseline in Facial Non-inflammatory Lesion Count (Open and Closed Comedones) [ Time Frame: From baseline to 12 weeks after first treatment ] [ Designated as safety issue: No ]
  • Erythema Score of Severe [ Time Frame: Immediately after first treatment ] [ Designated as safety issue: Yes ]
    Clinical assessment using a 4 point scale; none, mild, moderate, severe

  • Erythema Score of Mild and Moderate [ Time Frame: 2 days after first treatment ] [ Designated as safety issue: Yes ]
    Clinical assessment using a 4 point scale; none, mild, moderate, severe

  • Erythema Score of Severe [ Time Frame: 2 days after first treatment ] [ Designated as safety issue: Yes ]
    Clinical assessment using a 4 point scale; none, mild, moderate, severe

  • Mild and Moderate Scarring According to Scarring Score [ Time Frame: at week 12 after first treatment ] [ Designated as safety issue: No ]
    Clinical assessment using a 6 point scale; Clear, Almost clear, Mild, Moderate, Severe and Very severe

  • Severe and Very Severe Scarring According to Scarring Score [ Time Frame: at week 12 after first treatment ] [ Designated as safety issue: No ]
    Clinical assessment using a 6 point scale; Clear, Almost clear, Mild, Moderate, Severe and Very severe


Enrollment: 153
Study Start Date: May 2011
Study Completion Date: May 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Visonac cream with PDT
active treatment with light dose of 37 Joule/cm2
Drug: Visonac PDT
cream application prior to illumination with red light
Other Name: red light
Placebo Comparator: Vehicle cream with PDT
Placebo treatment, Light dose 37 Joule/cm2
Drug: Vehicle cream with PDT
placebo/vehicle cream application prior to illumination with red light
Other Name: red light

  Eligibility

Ages Eligible for Study:   12 Years to 35 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01347879

Locations
United States, California
Dermatology Specialists Inc
Oceanside, California, United States, 92056
Rady Children's Hospital
San Diego, California, United States, 92123
United States, Florida
North Florida Dermatology Associates
Jacksonville, Florida, United States, 32204
United States, Illinois
Altman Dermatology Associates
Arlington Heights, Illinois, United States, 60005
Dermatology Institute, DuPage Medical Group
Naperville, Illinois, United States, 60563
United States, Indiana
Deaconess Clinic Inc
Evansville, Indiana, United States, 47713
United States, Massachusetts
ActivMed Practices & Research Inc
Haverhill, Massachusetts, United States, 10830
United States, Michigan
Hamzavi Dermatology
Fort Gratiot, Michigan, United States, 48059
Somerset Skin Centre
Troy, Michigan, United States, 48084
United States, Pennsylvania
Penn State Hershey Medical Center
Hershey, Pennsylvania, United States, 17033
United States, Rhode Island
Clinical Partners LLC
Johnston, Rhode Island, United States, 02919
United States, Texas
DermResearch Inc
Austin, Texas, United States, 78759
Clinical Trials of Texas
San Antonio, Texas, United States, 78229
United States, Virginia
Virginia Clinical Research, Inc.
Norfolk, Virginia, United States, 23507
United States, Washington
Premier Clinical Research
Spokane, Washington, United States, 99216
Sponsors and Collaborators
PhotoCure
Investigators
Principal Investigator: David Pariser, MD Virginia Clinical Research, Inc.
  More Information

No publications provided

Responsible Party: PhotoCure
ClinicalTrials.gov Identifier: NCT01347879     History of Changes
Other Study ID Numbers: PCTA206/11
Study First Received: May 3, 2011
Results First Received: September 23, 2013
Last Updated: December 2, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by PhotoCure:
Acne vulgaris
PDT

Additional relevant MeSH terms:
Acne Vulgaris
Acneiform Eruptions
Facial Dermatoses
Sebaceous Gland Diseases
Skin Diseases

ClinicalTrials.gov processed this record on November 19, 2014