Photodynamic Therapy (PDT) With Methyl Aminolevulinate (MAL) Cream in Patients With Skin Type V or IV With Acne Vulgaris

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
PhotoCure
ClinicalTrials.gov Identifier:
NCT00673933
First received: May 5, 2008
Last updated: July 11, 2013
Last verified: July 2013
Results First Received: February 14, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Acne Vulgaris
Intervention: Drug: Methyl aminolevulinate (MAL) 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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Two areas on the back per patient was treated, one area with Visonac and one with vehicle

Reporting Groups
  Description
Visonac Cream With PDT and Vehicle and PDT Two areas on the back per patient was treated, one area with Visonac and one with vehicle. Methyl aminolevulinate (MAL) PDT : Cream application followed by illumination with red light

Participant Flow:   Overall Study
    Visonac Cream With PDT and Vehicle and PDT  
STARTED     20  
COMPLETED     17  
NOT COMPLETED     3  
Withdrawal by Subject                 2  
Lost to Follow-up                 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.
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Reporting Groups
  Description
Visonac and Vehicle Cream With PDT Two areas on the back per patient was treated, one area with Visonac (Methyl aminolevulinate) and one with vehicle followed by red light illumination.

Baseline Measures
    Visonac and Vehicle Cream With PDT  
Number of Participants  
[units: participants]
  20  
Age  
[units: participants]
 
<=18 years     4  
Between 18 and 65 years     16  
>=65 years     0  
Gender  
[units: participants]
 
Female     9  
Male     11  
Region of Enrollment  
[units: participants]
 
United States     20  
Skin type [1]
[units: participants]
 
Skin type V     18  
Skin type VI     2  
Inflammatory lesions  
[units: lesion]
Mean ( Full Range )
 
Visonac treated area     5.9  
  ( 5 to 11 )  
vehicle treated area     6.0  
  ( 5 to 10 )  
Non inflammatory lesions  
[units: Lesion]
Mean ( Full Range )
 
Visonac treated area     6.5  
  ( 1 to 21 )  
vehicle treated area     5.4  
  ( 2 to 17 )  
[1] Skin type according to the Fitzpatrick Classification Scale. Skin type V: Brown, dark brown.Very rarely burns, tans very easily Skin type VI: Black, very dark brown to black. Never burns, tans very easily, deeply pigmented



  Outcome Measures
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1.  Primary:   Proportion of Patients With Moderate to Severe Hypopigmentation and Hyperpigmentation Assessed After Treatment   [ Time Frame: 4 weeks after last treatment, 6 weeks after baseline ]

2.  Secondary:   Erythema Score (Mild and Moderate)Immediately After First PDT   [ Time Frame: Immediately after treatment at baseline ]

3.  Secondary:   Change in Inflammatory Lesion Counts From Baseline   [ Time Frame: 4 weeks after last treatment, 6 weeks after baseline ]

4.  Secondary:   Change in Noninflammatory Lesion Counts From Baseline   [ Time Frame: 4 weeks after last treatment, 6 weeks after baseline ]

5.  Secondary:   Erythema Score (Mild and Moderate)Immediately After Second Treatment   [ Time Frame: Immediately after second treatment, 2 weeks after baseline ]

6.  Secondary:   Erythema Score (Mild and Moderate)1 Day After First Treatment   [ Time Frame: 1 day after 1st treatment and baseline ]


  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
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  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: Dr Ashish Bhatia
Organization: Dermatology Institute
phone: 630-942-5040
e-mail: acbhatia@gmail.com


No publications provided


Responsible Party: PhotoCure
ClinicalTrials.gov Identifier: NCT00673933     History of Changes
Other Study ID Numbers: PC TA203/08
Study First Received: May 5, 2008
Results First Received: February 14, 2013
Last Updated: July 11, 2013
Health Authority: United States: Food and Drug Administration