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

July 2, 2009
November 15, 2013
August 2009
March 2010   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT00933543 on ClinicalTrials.gov Archive Site
  • 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 ]
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 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
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)

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Acne Vulgaris
  • 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
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
107
March 2010
March 2010   (final data collection date for primary outcome measure)

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.
Both
9 Years to 35 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT00933543
PC TA204/09
No
PhotoCure
PhotoCure
Not Provided
Principal Investigator: Lawrence F. Eichenfield, M.D Children's Specialists of San Diego / Rady Children's Hospital San Diego
PhotoCure
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP