Efficacy and Safety Study With Visonac Photodynamic Therapy (PDT)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
PhotoCure
ClinicalTrials.gov Identifier:
NCT00933543
First received: July 2, 2009
Last updated: November 15, 2013
Last verified: November 2013
  Purpose

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)


Condition Intervention Phase
Acne Vulgaris
Drug: Visonac PDT (MAL PDT)
Drug: Vehicle cream (placebo)
Procedure: 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: 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.

Resource links provided by NLM:


Further study details as provided by PhotoCure:

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

Secondary Outcome Measures:
  • Percent Change From Baseline in Facial Inflammatory (Nodules, Papules, and Pustules)Lesion Count [ Time Frame: 6 weeks after the first treatment ] [ Designated as safety issue: No ]
  • Percent Change From Baseline in Facial Inflammatory (Nodules, Papules, and Pustules)Lesion Count [ Time Frame: 12 weeks after the first treatment ] [ Designated as safety issue: No ]
  • Percent Change From Baseline in Facial Non Inflammatory Lesion Count [ Time Frame: 6 weeks after first treatment ] [ Designated as safety issue: No ]
  • Percent Change From Baseline in Facial Non Inflammatory Lesion Count [ Time Frame: 12 weeks after first treatment ] [ Designated as safety issue: No ]
  • Percent Change From Baseline in Facial Total Lesion Count [ Time Frame: 6 weeks after the first treatment ] [ Designated as safety issue: No ]
  • Percent Change From Baseline in Facial Total Lesion Count [ Time Frame: 12 weeks after the first treatment ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Absolute Change From Baseline in Facial Inflammatory Lesion Count [ Time Frame: 6 weeks after the first treatment ] [ Designated as safety issue: No ]
  • Absolute Change From Baseline in Facial Non- Inflammatory Lesion Count [ Time Frame: 6 weeks after the first treatment ] [ Designated as safety issue: No ]
  • Absolute Change From Baseline in Facial Total Lesion Count [ Time Frame: 6 weeks after the first treatment ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]
    Facial pain was assessed on a visual analogue scale ranging from 0-10cm.

  • 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 ] [ Designated as safety issue: Yes ]
    Facial pain was assessed on a visual analogue scale ranging from 0-10cm.

  • 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 ] [ Designated as safety issue: Yes ]
    Facial pain was assessed on a visual analogue scale ranging from 0-10cm.

  • 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 ] [ Designated as safety issue: Yes ]
    Facial pain was assessed on a visual analogue scale ranging from 0-10cm.

  • Proportion of Patients With Mild and Moderate Hyperpigmentation [ Time Frame: at 12 weeks after first treatment ] [ Designated as safety issue: Yes ]
  • Proportion of Patients With Severe Hyperpigmentation [ Time Frame: at 12 weeks after first treatment ] [ Designated as safety issue: Yes ]
  • Proportion of Patients With Mild or Moderate Scarring at End of Study [ Time Frame: week 12 ] [ Designated as safety issue: Yes ]
  • Proportion of Patients With Clear or Almost Clear Scarring at End of Study [ Time Frame: week 12 ] [ Designated as safety issue: Yes ]
  • Proportion of Patients With Severe and Very Severe Scarring at End of Study [ Time Frame: week 12 ] [ Designated as safety issue: Yes ]
  • Proportion of Patients With Hypopigmentation (Mild Moderate, Severe) [ Time Frame: at 12 weeks after first treatment ] [ Designated as safety issue: Yes ]
  • Proportion of Patients With Dryness (Mild) [ Time Frame: at 12 weeks after first treatment ] [ Designated as safety issue: Yes ]

Enrollment: 107
Study Start Date: August 2009
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Visonac cream with PDT
Active treatment, Light dose 37 J/cm2.
Drug: Visonac PDT (MAL PDT)
Cream application followed by illumination with red light.
Other Names:
  • Visonac
  • MAL PDT
  • red light
Procedure: PDT
Photodynamic Therapy - Light dose 37 J/cm2
Other Name: Red light
Placebo Comparator: Vehicle cream with PDT
Placebo treatment, Light dose 37 J/cm2.
Drug: Vehicle cream (placebo)
Cream application followed by illumination with red light.
Other Names:
  • Vehicle cream
  • MAL PDT
  • red light
Procedure: PDT
Photodynamic Therapy - Light dose 37 J/cm2
Other Name: Red light

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.

  Eligibility

Ages Eligible for Study:   9 Years to 35 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

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.
  • 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.
  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: NCT00933543

Locations
United States, California
Children's Specialists of San Diego / Rady Children's Hospital San Diego
San Diego, California, United States, 92123
United States, Illinois
DeNova Research
Chicago, Illinois, United States, 60611
Dermatology Institute of DuPage Medical Group
Naperville, Illinois, United States, 60563
United States, Minnesota
Minnesota Clinical Study Center
Fridley, Minnesota, United States, 55432
United States, New York
Dermatology Associates of Rochester
Rochester, New York, United States, 14623
United States, Pennsylvania
Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033
United States, Virginia
Virginia Clinical Research, Inc.
Norfolk, Virginia, United States, 23507
United States, Wisconsin
Madison Skin & Research, Inc
Madison, Wisconsin, United States, 53719
Canada, Ontario
Windsor Clinical Research, Inc.
Windsor, Ontario N8W 5L7, Ontario, Canada, N8W 5L7
Canada, Quebec
INNOVADERM Research Inc.
Montreal, Quebec, Canada
Centre de Recherche Dermatologique
Québec, Quebec, Canada, 2880
Sponsors and Collaborators
PhotoCure
Investigators
Principal Investigator: Lawrence F. Eichenfield, M.D Children's Specialists of San Diego / Rady Children's Hospital San Diego
  More Information

No publications provided

Responsible Party: PhotoCure
ClinicalTrials.gov Identifier: NCT00933543     History of Changes
Other Study ID Numbers: PC TA204/09
Study First Received: July 2, 2009
Results First Received: March 14, 2013
Last Updated: November 15, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by PhotoCure:
Acne Vulgaris
Moderate to severe

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

ClinicalTrials.gov processed this record on July 23, 2014