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
Results First Received: March 14, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Acne Vulgaris
Interventions: Drug: Visonac PDT (MAL PDT)
Drug: Vehicle cream (placebo)
Procedure: PDT

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment from September-December 2009. Dermatology clinics, with pediatric patients

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
None

Reporting Groups
  Description
Visonac Cream With PDT Active treatment, Light dose 37 J/cm2.
Vehicle Cream With PDT Placebo treatment, Light dose 37 J/cm2.

Participant Flow:   Overall Study
    Visonac Cream With PDT     Vehicle Cream With PDT  
STARTED     54     53  
COMPLETED     51     46  
NOT COMPLETED     3     7  
Adverse Event                 2                 1  
Lost to Follow-up                 0                 1  
Withdrawal by Subject                 0                 1  
Lack of Efficacy                 0                 3  
Not known                 1                 1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Visonac Cream With PDT Active treatment, Light dose 37 J/cm2.
Vehicle Cream With PDT Placebo treatment, Light dose 37 J/cm2.
Total Total of all reporting groups

Baseline Measures
    Visonac Cream With PDT     Vehicle Cream With PDT     Total  
Number of Participants  
[units: participants]
  54     53     107  
Age  
[units: participants]
     
<=18 years     35     34     69  
Between 18 and 65 years     19     19     38  
>=65 years     0     0     0  
Gender  
[units: participants]
     
Female     32     27     59  
Male     22     26     48  
Region of Enrollment  
[units: participants]
     
Canada     17     16     33  
United States     37     37     74  
Patients with mild and moderate hyperpigmentation  
[units: number of patients]
     
No hyperpigmentation     39     34     73  
Mild hyperpigmentation     5     10     15  
Moderate hyperpigmentation     8     8     16  
Severe hyperpigmentation     2     1     3  
Investigator Global Assessment (IGA) Score  
[units: participants]
     
IGA 3 (Moderate acne)     44     45     89  
IGA 4 (Severe acne)     10     8     18  
Fitzpatrick Skin type [1]
[units: participants]
     
Skin type I     5     6     11  
Skin type II     14     15     29  
Skin type III     24     21     45  
Skin type IV     4     6     10  
Skin type V     5     2     7  
Skin type VI     2     3     5  
Scarring [2]
[units: number of patients]
     
Patients with no scarring     21     26     47  
Patients with almost clear scarring     9     10     19  
Patients with mild scarring     15     9     24  
Patients with moderate scarring     6     6     12  
Patients with severe scarring     3     1     4  
Patients with very severe scarring     0     1     1  
Patients with dryness [3]
[units: Number of patients]
     
No dryness     45     46     91  
Mild dryness     9     7     16  
[1] I: White; very fair; red or blond hair; blue eyes; freckles Always burns, never tans II: White; fair; red or blond hair; blue, hazel or green eyes Usually burns, tans with difficulty III: Cream white; fair with any eye or hair color; very common Sometimes mild burn, gradually tans IV: Brown; typical Mediterranean Caucasian skin Rarely burns, tans with ease V: Dark brown; Middle Eastern skin types Very rarely burns, tans very easily VI: Black Never burns, tans very easily
[2]

The investigator assess the scarring using a scale called SCAR-S. Clear 0: No visible scars from acne. Almost clear 1: Hardly visible scars from 2.5 meters away. Mild 2: Easily recognizable, less than ½ the affected area (eg. face, back or chest) involved.

Moderate 3: More than ½ affected area (eg. face, back or chest) involved. Severe 4: Entire area involved. Very severe 5: Entire area with prominent atrophic or hypertrophic scars.

[3] The investigator assess the dryness using a scale from 0 to 3 (0=absence, 1=mild, 2=moderate, 3=severe).



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   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 ]

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

3.  Primary:   Absolute Change From Baseline in Facial Non Inflammatory Lesion Count   [ Time Frame: 12 weeks after first treatment ]

4.  Secondary:   Percent Change From Baseline in Facial Inflammatory (Nodules, Papules, and Pustules)Lesion Count   [ Time Frame: 6 weeks after the first treatment ]

5.  Secondary:   Percent Change From Baseline in Facial Inflammatory (Nodules, Papules, and Pustules)Lesion Count   [ Time Frame: 12 weeks after the first treatment ]

6.  Secondary:   Percent Change From Baseline in Facial Non Inflammatory Lesion Count   [ Time Frame: 6 weeks after first treatment ]

7.  Secondary:   Percent Change From Baseline in Facial Non Inflammatory Lesion Count   [ Time Frame: 12 weeks after first treatment ]

8.  Secondary:   Percent Change From Baseline in Facial Total Lesion Count   [ Time Frame: 6 weeks after the first treatment ]

9.  Secondary:   Percent Change From Baseline in Facial Total Lesion Count   [ Time Frame: 12 weeks after the first treatment ]

10.  Secondary:   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 ]

11.  Secondary:   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 ]

12.  Secondary:   Absolute Change From Baseline in Facial Inflammatory Lesion Count   [ Time Frame: 6 weeks after the first treatment ]

13.  Secondary:   Absolute Change From Baseline in Facial Non- Inflammatory Lesion Count   [ Time Frame: 6 weeks after the first treatment ]

14.  Secondary:   Absolute Change From Baseline in Facial Total Lesion Count   [ Time Frame: 6 weeks after the first treatment ]

15.  Secondary:   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 ]

16.  Secondary:   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 ]

17.  Secondary:   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 ]

18.  Secondary:   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 ]

19.  Secondary:   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 ]

20.  Secondary:   Proportion of Patients With Mild and Moderate Hyperpigmentation   [ Time Frame: at 12 weeks after first treatment ]

21.  Secondary:   Proportion of Patients With Severe Hyperpigmentation   [ Time Frame: at 12 weeks after first treatment ]

22.  Secondary:   Proportion of Patients With Mild or Moderate Scarring at End of Study   [ Time Frame: week 12 ]

23.  Secondary:   Proportion of Patients With Clear or Almost Clear Scarring at End of Study   [ Time Frame: week 12 ]

24.  Secondary:   Proportion of Patients With Severe and Very Severe Scarring at End of Study   [ Time Frame: week 12 ]

25.  Secondary:   Proportion of Patients With Hypopigmentation (Mild Moderate, Severe)   [ Time Frame: at 12 weeks after first treatment ]

26.  Secondary:   Proportion of Patients With Dryness (Mild)   [ Time Frame: at 12 weeks after first treatment ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Project director Per Fuglerud
Organization: Photocure
phone: +47 22 06 16 54
e-mail: pf@photocure.no


No publications provided


Responsible Party: PhotoCure
ClinicalTrials.gov Identifier: NCT00933543     History of Changes
Other Study ID Numbers: PC TA204/09
Study First Received: July 2, 2009
Results First Received: March 14, 2013
Last Updated: November 15, 2013
Health Authority: United States: Food and Drug Administration