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Efficacy and Safety Study With Visonac Photodynamic Therapy (PDT)

Primary Purpose

Acne Vulgaris

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Visonac PDT (MAL PDT)
Vehicle cream (placebo)
PDT
Sponsored by
Photocure
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acne Vulgaris focused on measuring Acne Vulgaris, Moderate to severe

Eligibility Criteria

9 Years - 35 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Children's Specialists of San Diego / Rady Children's Hospital San Diego
  • DeNova Research
  • Dermatology Institute of DuPage Medical Group
  • Minnesota Clinical Study Center
  • Dermatology Associates of Rochester
  • Milton S. Hershey Medical Center
  • Virginia Clinical Research, Inc.
  • Madison Skin & Research, Inc
  • Windsor Clinical Research, Inc.
  • INNOVADERM Research Inc.
  • Centre de Recherche Dermatologique

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Visonac cream with PDT

Vehicle cream with PDT

Arm Description

Active treatment, Light dose 37 J/cm2.

Placebo treatment, Light dose 37 J/cm2.

Outcomes

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.
Absolute Change From Baseline in Facial Inflammatory Lesion Count (Nodules, Papules, and Pustules)
Absolute Change From Baseline in Facial Non Inflammatory Lesion Count

Secondary Outcome Measures

Percent Change From Baseline in Facial Inflammatory (Nodules, Papules, and Pustules)Lesion Count
Percent Change From Baseline in Facial Inflammatory (Nodules, Papules, and Pustules)Lesion Count
Percent Change From Baseline in Facial Non Inflammatory Lesion Count
Percent Change From Baseline in Facial Non Inflammatory Lesion Count
Percent Change From Baseline in Facial Total Lesion Count
Percent Change From Baseline in Facial Total Lesion Count
Proportion of Patients With a Reduction of at Least 50% From Baseline in Facial Non-inflammatory Lesion Count
Proportion of Patients With a Reduction of at Least 50% From Baseline in Facial Inflammatory Lesion Count From Baseline
Absolute Change From Baseline in Facial Inflammatory Lesion Count
Absolute Change From Baseline in Facial Non- Inflammatory Lesion Count
Absolute Change From Baseline in Facial Total Lesion Count
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.
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.
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.
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.
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.
Proportion of Patients With Mild and Moderate Hyperpigmentation
Proportion of Patients With Severe Hyperpigmentation
Proportion of Patients With Mild or Moderate Scarring at End of Study
Proportion of Patients With Clear or Almost Clear Scarring at End of Study
Proportion of Patients With Severe and Very Severe Scarring at End of Study
Proportion of Patients With Hypopigmentation (Mild Moderate, Severe)
Proportion of Patients With Dryness (Mild)

Full Information

First Posted
July 2, 2009
Last Updated
November 15, 2013
Sponsor
Photocure
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1. Study Identification

Unique Protocol Identification Number
NCT00933543
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.
Study Type
Interventional

2. Study Status

Record Verification Date
November 2013
Overall Recruitment Status
Completed
Study Start Date
August 2009 (undefined)
Primary Completion Date
March 2010 (Actual)
Study Completion Date
March 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Photocure

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acne Vulgaris
Keywords
Acne Vulgaris, Moderate to severe

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
107 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Visonac cream with PDT
Arm Type
Experimental
Arm Description
Active treatment, Light dose 37 J/cm2.
Arm Title
Vehicle cream with PDT
Arm Type
Placebo Comparator
Arm Description
Placebo treatment, Light dose 37 J/cm2.
Intervention Type
Drug
Intervention Name(s)
Visonac PDT (MAL PDT)
Other Intervention Name(s)
Visonac, MAL PDT, red light
Intervention Description
Cream application followed by illumination with red light.
Intervention Type
Drug
Intervention Name(s)
Vehicle cream (placebo)
Other Intervention Name(s)
Vehicle cream, MAL PDT, red light
Intervention Description
Cream application followed by illumination with red light.
Intervention Type
Procedure
Intervention Name(s)
PDT
Other Intervention Name(s)
Red light
Intervention Description
Photodynamic Therapy - Light dose 37 J/cm2
Primary Outcome Measure Information:
Title
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
Title
Absolute Change From Baseline in Facial Inflammatory Lesion Count (Nodules, Papules, and Pustules)
Time Frame
12 weeks after the first treatment
Title
Absolute Change From Baseline in Facial Non Inflammatory Lesion Count
Time Frame
12 weeks after first treatment
Secondary Outcome Measure Information:
Title
Percent Change From Baseline in Facial Inflammatory (Nodules, Papules, and Pustules)Lesion Count
Time Frame
6 weeks after the first treatment
Title
Percent Change From Baseline in Facial Inflammatory (Nodules, Papules, and Pustules)Lesion Count
Time Frame
12 weeks after the first treatment
Title
Percent Change From Baseline in Facial Non Inflammatory Lesion Count
Time Frame
6 weeks after first treatment
Title
Percent Change From Baseline in Facial Non Inflammatory Lesion Count
Time Frame
12 weeks after first treatment
Title
Percent Change From Baseline in Facial Total Lesion Count
Time Frame
6 weeks after the first treatment
Title
Percent Change From Baseline in Facial Total Lesion Count
Time Frame
12 weeks after the first treatment
Title
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
Title
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
Title
Absolute Change From Baseline in Facial Inflammatory Lesion Count
Time Frame
6 weeks after the first treatment
Title
Absolute Change From Baseline in Facial Non- Inflammatory Lesion Count
Time Frame
6 weeks after the first treatment
Title
Absolute Change From Baseline in Facial Total Lesion Count
Time Frame
6 weeks after the first treatment
Title
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
Title
Facial Pain Assessed Using a Visual Analogue Scale From 0 to 10, Where 0 Indicates no Pain and 10 Indicates Worst Pain Imaginable
Description
Facial pain was assessed on a visual analogue scale ranging from 0-10cm.
Time Frame
directly after first treatment
Title
Facial Pain Assessed Using a Visual Analogue Scale From 0 to 10, Where 0 Indicates no Pain and 10 Indicates Worst Pain Imaginable
Description
Facial pain was assessed on a visual analogue scale ranging from 0-10cm.
Time Frame
directly after second treatment
Title
Facial Pain Assessed Using a Visual Analogue Scale From 0 to 10, Where 0 Indicates no Pain and 10 Indicates Worst Pain Imaginable
Description
Facial pain was assessed on a visual analogue scale ranging from 0-10cm.
Time Frame
directly after third treatment
Title
Facial Pain Assessed Using a Visual Analogue Scale From 0 to 10, Where 0 Indicates no Pain and 10 Indicates Worst Pain Imaginable
Description
Facial pain was assessed on a visual analogue scale ranging from 0-10cm.
Time Frame
directly after fourth treatment
Title
Proportion of Patients With Mild and Moderate Hyperpigmentation
Time Frame
at 12 weeks after first treatment
Title
Proportion of Patients With Severe Hyperpigmentation
Time Frame
at 12 weeks after first treatment
Title
Proportion of Patients With Mild or Moderate Scarring at End of Study
Time Frame
week 12
Title
Proportion of Patients With Clear or Almost Clear Scarring at End of Study
Time Frame
week 12
Title
Proportion of Patients With Severe and Very Severe Scarring at End of Study
Time Frame
week 12
Title
Proportion of Patients With Hypopigmentation (Mild Moderate, Severe)
Time Frame
at 12 weeks after first treatment
Title
Proportion of Patients With Dryness (Mild)
Time Frame
at 12 weeks after first treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
9 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lawrence F. Eichenfield, M.D
Organizational Affiliation
Children's Specialists of San Diego / Rady Children's Hospital San Diego
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Specialists of San Diego / Rady Children's Hospital San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
DeNova Research
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Dermatology Institute of DuPage Medical Group
City
Naperville
State/Province
Illinois
ZIP/Postal Code
60563
Country
United States
Facility Name
Minnesota Clinical Study Center
City
Fridley
State/Province
Minnesota
ZIP/Postal Code
55432
Country
United States
Facility Name
Dermatology Associates of Rochester
City
Rochester
State/Province
New York
ZIP/Postal Code
14623
Country
United States
Facility Name
Milton S. Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Facility Name
Virginia Clinical Research, Inc.
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
Facility Name
Madison Skin & Research, Inc
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53719
Country
United States
Facility Name
Windsor Clinical Research, Inc.
City
Windsor, Ontario N8W 5L7
State/Province
Ontario
ZIP/Postal Code
N8W 5L7
Country
Canada
Facility Name
INNOVADERM Research Inc.
City
Montreal
State/Province
Quebec
Country
Canada
Facility Name
Centre de Recherche Dermatologique
City
Québec
State/Province
Quebec
ZIP/Postal Code
2880
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

Efficacy and Safety Study With Visonac Photodynamic Therapy (PDT)

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