Efficacy and Safety Study With Visonac Photodynamic Therapy (PDT)

• ClinicalTrials.gov Identifier: NCT00933543
• Recruitment Status: Completed
• First Posted: July 7, 2009
• Results First Posted: November 15, 2013
• Last Update Posted: December 11, 2013
• Sponsor: Photocure
• Information provided by (Responsible Party): Photocure

Tracking Information

• First Submitted Date: July 2, 2009
• First Posted Date: July 7, 2009
• Results First Submitted Date: March 14, 2013
• Results First Posted Date: November 15, 2013
• Last Update Posted Date: December 11, 2013
• Study Start Date: August 2009
• Actual Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: October 22, 2013)

• 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 ]
• Absolute Change From Baseline in Facial Inflammatory Lesion Count (Nodules, Papules, and Pustules) [ Time Frame: 12 weeks after the first treatment ]
• Absolute Change From Baseline in Facial Non Inflammatory Lesion Count [ Time Frame: 12 weeks after first treatment ]

• Original Primary Outcome Measures (submitted: July 6, 2009): 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 ]
• Change History: Complete list of historical versions of study NCT00933543 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures (submitted: November 15, 2013)

• Percent Change From Baseline in Facial Inflammatory (Nodules, Papules, and Pustules)Lesion Count [ Time Frame: 6 weeks after the first treatment ]
• Percent Change From Baseline in Facial Inflammatory (Nodules, Papules, and Pustules)Lesion Count [ Time Frame: 12 weeks after the first treatment ]
• Percent Change From Baseline in Facial Non Inflammatory Lesion Count [ Time Frame: 6 weeks after first treatment ]
• Percent Change From Baseline in Facial Non Inflammatory Lesion Count [ Time Frame: 12 weeks after first treatment ]
• Percent Change From Baseline in Facial Total Lesion Count [ Time Frame: 6 weeks after the first treatment ]
• Percent Change From Baseline in Facial Total Lesion Count [ Time Frame: 12 weeks after the first treatment ]
• 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 ]
• 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 ]
• Absolute Change From Baseline in Facial Inflammatory Lesion Count [ Time Frame: 6 weeks after the first treatment ]
• Absolute Change From Baseline in Facial Non- Inflammatory Lesion Count [ Time Frame: 6 weeks after the first treatment ]
• Absolute Change From Baseline in Facial Total Lesion Count [ Time Frame: 6 weeks after the first treatment ]
• 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 ]
• 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 ]
  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 ]
  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 ]
  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 ]
  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 ]
• Proportion of Patients With Severe Hyperpigmentation [ Time Frame: at 12 weeks after first treatment ]
• Proportion of Patients With Mild or Moderate Scarring at End of Study [ Time Frame: week 12 ]
• Proportion of Patients With Clear or Almost Clear Scarring at End of Study [ Time Frame: week 12 ]
• Proportion of Patients With Severe and Very Severe Scarring at End of Study [ Time Frame: week 12 ]
• Proportion of Patients With Hypopigmentation (Mild Moderate, Severe) [ Time Frame: at 12 weeks after first treatment ]
• Proportion of Patients With Dryness (Mild) [ Time Frame: at 12 weeks after first treatment ]

• Original Secondary Outcome Measures (submitted: July 6, 2009): Proportion of patients with success according to the dichotomized IGA scale based on the facial (excluding lesions on nose) assessment at 12 weeks after the first treatment. [ Time Frame: 12 weeks after the first treatment ]
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Efficacy and Safety Study With Visonac Photodynamic Therapy (PDT)
• 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.
• Brief Summary: 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)

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.

• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Acne Vulgaris

Intervention

• Drug: Visonac PDT (MAL PDT)
  Cream application followed by illumination with red light.
  Other Names:

  • Visonac
  • MAL PDT
  • red light
• 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

Study Arms

• Experimental: Visonac cream with PDT
  Active treatment, Light dose 37 J/cm2.
  Interventions:

  • Drug: Visonac PDT (MAL PDT)
  • Procedure: PDT
• Placebo Comparator: Vehicle cream with PDT
  Placebo treatment, Light dose 37 J/cm2.
  Interventions:

  • Drug: Vehicle cream (placebo)
  • Procedure: PDT

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: October 22, 2013): 107
• Original Estimated Enrollment (submitted: July 6, 2009): 100
• Actual Study Completion Date: March 2010
• Actual Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 9 Years to 35 Years (Child, Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Canada, United States

Administrative Information

• NCT Number: NCT00933543
• Other Study ID Numbers: PC TA204/09
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Photocure
• Study Sponsor: Photocure
• Collaborators: Not Provided

Investigators

• Principal Investigator: Lawrence F. Eichenfield, M.D; Children's Specialists of San Diego / Rady Children's Hospital San Diego

• PRS Account: Photocure
• Verification Date: November 2013