Efficacy and Safety Study With Visonac Photodynamic Therapy (PDT)

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.

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)

Study Overview

• Status: Completed
• Conditions: Acne Vulgaris
• Intervention / Treatment: Drug: Visonac PDT (MAL PDT); Procedure: PDT; Drug: Vehicle cream (placebo)

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
• Enrollment (Actual): 107
• Phase: Phase 2

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Windsor, Ontario N8W 5L7, Ontario, Canada, N8W 5L7
      • Windsor Clinical Research, Inc.
  • Quebec
    • Montreal, Quebec, Canada
      • Innovaderm Research Inc.
    • Québec, Quebec, Canada, 2880
      • Centre de Recherche Dermatologique
• United States
  • California
    • San Diego, California, United States, 92123
      • Children's Specialists of San Diego / Rady Children's Hospital San Diego
  • Illinois
    • Chicago, Illinois, United States, 60611
      • DeNova Research
    • Naperville, Illinois, United States, 60563
      • Dermatology Institute of DuPage Medical Group
  • Minnesota
    • Fridley, Minnesota, United States, 55432
      • Minnesota Clinical Study Center
  • New York
    • Rochester, New York, United States, 14623
      • Dermatology Associates of Rochester
  • Pennsylvania
    • Hershey, Pennsylvania, United States, 17033
      • Milton S. Hershey Medical Center
  • Virginia
    • Norfolk, Virginia, United States, 23507
      • Virginia Clinical Research, Inc.
  • Wisconsin
    • Madison, Wisconsin, United States, 53719
      • Madison Skin & Research, Inc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 9 years to 35 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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: red light; MAL PDT; Visonac; Procedure: PDT; Photodynamic Therapy - Light dose 37 J/cm2; Other Names: Red light
Placebo Comparator: Vehicle cream with PDT; Placebo treatment, Light dose 37 J/cm2.	Procedure: PDT; Photodynamic Therapy - Light dose 37 J/cm2; Other Names: Red light; Drug: Vehicle cream (placebo); Cream application followed by illumination with red light.; Other Names: Vehicle cream; red light; MAL PDT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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.	12 weeks after the first treatment
Absolute Change From Baseline in Facial Inflammatory Lesion Count (Nodules, Papules, and Pustules)	12 weeks after the first treatment
Absolute Change From Baseline in Facial Non Inflammatory Lesion Count	12 weeks after first treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent Change From Baseline in Facial Inflammatory (Nodules, Papules, and Pustules)Lesion Count		6 weeks after the first treatment
Percent Change From Baseline in Facial Inflammatory (Nodules, Papules, and Pustules)Lesion Count		12 weeks after the first treatment
Percent Change From Baseline in Facial Non Inflammatory Lesion Count		6 weeks after first treatment
Percent Change From Baseline in Facial Non Inflammatory Lesion Count		12 weeks after first treatment
Percent Change From Baseline in Facial Total Lesion Count		6 weeks after the first treatment
Percent Change From Baseline in Facial Total Lesion Count		12 weeks after the first treatment
Proportion of Patients With a Reduction of at Least 50% From Baseline in Facial Non-inflammatory Lesion Count		12 weeks after last treatment
Proportion of Patients With a Reduction of at Least 50% From Baseline in Facial Inflammatory Lesion Count From Baseline		12 weeks after first treatment
Absolute Change From Baseline in Facial Inflammatory Lesion Count		6 weeks after the first treatment
Absolute Change From Baseline in Facial Non- Inflammatory Lesion Count		6 weeks after the first treatment
Absolute Change From Baseline in Facial Total Lesion Count		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.		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	Facial pain was assessed on a visual analogue scale ranging from 0-10cm.	directly after 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	Facial pain was assessed on a visual analogue scale ranging from 0-10cm.	directly after second treatment
Facial Pain Assessed Using a Visual Analogue Scale From 0 to 10, Where 0 Indicates no Pain and 10 Indicates Worst Pain Imaginable	Facial pain was assessed on a visual analogue scale ranging from 0-10cm.	directly after third treatment
Facial Pain Assessed Using a Visual Analogue Scale From 0 to 10, Where 0 Indicates no Pain and 10 Indicates Worst Pain Imaginable	Facial pain was assessed on a visual analogue scale ranging from 0-10cm.	directly after fourth treatment
Proportion of Patients With Mild and Moderate Hyperpigmentation		at 12 weeks after first treatment
Proportion of Patients With Severe Hyperpigmentation		at 12 weeks after first treatment
Proportion of Patients With Mild or Moderate Scarring at End of Study		week 12
Proportion of Patients With Clear or Almost Clear Scarring at End of Study		week 12
Proportion of Patients With Severe and Very Severe Scarring at End of Study		week 12
Proportion of Patients With Hypopigmentation (Mild Moderate, Severe)		at 12 weeks after first treatment
Proportion of Patients With Dryness (Mild)		at 12 weeks after first treatment

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start: August 1, 2009
• Primary Completion (Actual): March 1, 2010
• Study Completion (Actual): March 1, 2010

Study Registration Dates

• First Submitted: July 2, 2009
• First Submitted That Met QC Criteria: July 6, 2009
• First Posted (Estimate): July 7, 2009

Study Record Updates

• Last Update Posted (Estimate): December 11, 2013
• Last Update Submitted That Met QC Criteria: November 15, 2013
• Last Verified: November 1, 2013

More Information

Terms related to this study

• Keywords: Acne Vulgaris; Moderate to severe
• Additional Relevant MeSH Terms: Skin Diseases; Acneiform Eruptions; Sebaceous Gland Diseases; Acne Vulgaris
• Other Study ID Numbers: PC TA204/09