Clinical Trial: A Double Blinded, Prospective, Randomized, Vehicle Controlled Multi-center Study of Photodynamic Therapy With Visonac® Cream in Patients With Acne Vulgaris

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: PCTA206/11 A Double Blinded, Prospective, Randomized, Vehicle Controlled Multi Center Study of Photodynamic Therapy With Visonac® Cream in Patients With Acne Vulgaris

Brief Summary: This study is intended to evaluate the efficacy and safety of Visonac Photodynamic Therapy (PDT) in patients with severe acne, score 4 on global IGA scale. The null hypothesis is that Visonac PDT is equal to vehicle PDT against the alternative hypothesis that Visonac PDT is different compared to vehicle PDT at week 12.

Detailed Summary:
Sponsor: Photocure

Current Primary Outcome: Absolute Change From Baseline in Facial Inflammatory Lesion Count (Nodules, Papules, and Pustules). [ Time Frame: From baseline to 12 weeks after first treatment ]

Original Primary Outcome: Absolute change from baseline in facial inflammatory lesion count (nodules, papules, and pustules) 12 weeks after the first treatment.

Current Secondary Outcome:

  • Absolute Change From Baseline in Facial Non-inflammatory Lesion Count (Open and Closed Comedones) [ Time Frame: From baseline to 12 weeks after the first treatment ]
  • Percent Change From Baseline in Facial Inflammatory (Nodules, Papules, and Pustules)Lesion Counts. [ Time Frame: From baseline to 12 weeks after the first treatment ]
  • Proportion of Patients With Success According to IGA Scale Based on the Facial Assessment. [ Time Frame: From baseline to 12 weeks after first treatment ]
    One Investigator Global Assessment (IGA) scale was used including inflammatory and non-inflammatory lesions. The investigator qualitatively graded the overall acne severity on a scale from 0 to 4, with 4 being the most severe. Success was defined as an improvement of at least 2 grades from the baseline score.
  • Pain During Illumination. [ Time Frame: Immediately after first treatment ]
    Pain during illumination was assessed by patient using a Visual Analogue Scale (VAS) from 0 to 10, where 0 indicates no pain and 10 indicates the worst pain imaginable.
  • Number of Patients With Adverse Events. [ Time Frame: From administration of investigational medicinal product (IMP) until 12 weeks after first IMP administration ]
  • Erythema Score of Mild and Moderate [ Time Frame: Immediately after first treatment ]
    Clinical assessment using a 4 point scale; none, mild, moderate, severe
  • Clear and Almost Clear Scarring According to Scarring Score [ Time Frame: at week 12 after first treatment ]
    Clinical assessment using a 6 point scale; Clear, Almost clear, Mild, Moderate, Severe and Very severe
  • Percent Change From Baseline in Facial Non-inflammatory Lesion Count (Open and Closed Comedones) [ Time Frame: From baseline to 12 weeks after first treatment ]
  • Erythema Score of Severe [ Time Frame: Immediately after first treatment ]
    Clinical assessment using a 4 point scale; none, mild, moderate, severe
  • Erythema Score of Mild and Moderate [ Time Frame: 2 days after first treatment ]
    Clinical assessment using a 4 point scale; none, mild, moderate, severe
  • Erythema Score of Severe [ Time Frame: 2 days after first treatment ]
    Clinical assessment using a 4 point scale; none, mild, moderate, severe
  • Mild and Moderate Scarring According to Scarring Score [ Time Frame: at week 12 after first treatment ]
    Clinical assessment using a 6 point scale; Clear, Almost clear, Mild, Moderate, Severe and Very severe
  • Severe and Very Severe Scarring According to Scarring Score [ Time Frame: at week 12 after first treatment ]
    Clinical assessment using a 6 point scale; Clear, Almost clear, Mild, Moderate, Severe and Very severe


Original Secondary Outcome:

Information By: Photocure

Dates:
Date Received: May 3, 2011
Date Started: May 2011
Date Completion:
Last Updated: December 2, 2013
Last Verified: December 2013