Conditions: Edematous Fibrosclerotic Panniculopathy (EFP) Cellulite
Allocation: NON_RANDOMIZED | Intervention model: PARALLEL
Enrollment: 153
Healthy volunteers: yes

Brief summary:
This is a multicenter, open-label, multiple dose, 2 cohort, Phase 3b study to assess the safety and efficacy of CCH in adult women with mild or moderate edematous fibrosclerotic panniculopathy (EFP).

Cohort 1 will include approximately 80 subjects with mild or moderate EFP in the posterolateral thighs and Cohort 2 will include approximately 70 subjects with mild or moderate EFP in the buttocks.

Detailed description:

Arms:
arm 1: EN3835 up to 1.68mg (Collagenase Clostridium Histolyticum) arm 2: EN3835 up to 1.68mg (Collagenase Clostridium Histolyticum)

Interventions: intervention 1: EN3835
Intervention descriptions: intervention 1: Collagenase Clostridium Histolyticum (CCH)

Protocol document:
Prot_000.pdf: 


                 
   
      
            
        
   
 
     
      
 
 
 
                                       
 
   
                                                    
            
 
 
   
                                
                           
 
      
                    
        
           
                      
                                   
   
 
                         
          
   
        
              
          
                   
    
                
      
                     
 
                
              
  
                                                     
               
        
        
       
      
                    
           
 
          
           
 
  
           
        
                
          
        
         
    
            
                          
                    
                   
    
                                        
                      
  
                           
     
 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