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Efficacy and Safety Study of Finacea to Treat Acne Vulgaris and Post-Inflammatory Hyperpigmentation (PIH)

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ClinicalTrials.gov Identifier: NCT01038869
Recruitment Status : Completed
First Posted : December 24, 2009
Results First Posted : September 25, 2012
Last Update Posted : September 25, 2012
Sponsor:
Collaborator:
Bayer
Information provided by (Responsible Party):
Leon Kircik, M.D., Derm Research, PLLC

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Acne Vulgaris
Post Inflammatory Hyperpigmentation
Intervention: Drug: Azelaic acid

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Subjects recruited from private office population.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Finacea Open label pilot study. All subjects were given Azelaic acid 15% to be used topically, twice daily.

Participant Flow:   Overall Study
    Finacea
STARTED   20 
COMPLETED   13 
NOT COMPLETED   7 
Withdrawal by Subject                1 
Lost to Follow-up                6 



  Baseline Characteristics

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
Finacea Open label pilot study

Baseline Measures
   Finacea 
Overall Participants Analyzed 
[Units: Participants]
 20 
Age 
[Units: Participants]
 
<=18 years   8 
Between 18 and 65 years   12 
>=65 years   0 
Age 
[Units: Years]
Mean (Standard Deviation)
 24  (10.63) 
Gender 
[Units: Participants]
 
Female   15 
Male   5 
Region of Enrollment 
[Units: Participants]
 
United States   20 


  Outcome Measures

1.  Primary:   Percentage of Participants With Improvement in Acne IGA (Investigator Global Assessment)   [ Time Frame: Baseline to 16 weeks ]

2.  Secondary:   Percentage of Participants With Improvement in the IGA of Post Inflammatory Hyperpigmentation(PIH)   [ Time Frame: Baseline to16 weeks ]

3.  Secondary:   Percentage of Participants With an Improvement in Post Inflammatory Hyperpigmentation (PIH) % Distribution   [ Time Frame: Baseline to 16 weeks ]

4.  Secondary:   Percentage Change in Total Lesion Counts   [ Time Frame: Baseline to 16 weeks ]

5.  Secondary:   Tolerability Assessments as Measured by the Number of Participants With Side Effects   [ Time Frame: 16 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

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
This is an open-label study with a small number of subjects.


  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Leon Kircik, M.D.
Organization: DermResearch, PLLC
phone: 502-451-9000
e-mail: wedoderm@yahoo.com



Responsible Party: Leon Kircik, M.D., Derm Research, PLLC
ClinicalTrials.gov Identifier: NCT01038869     History of Changes
Other Study ID Numbers: FIN0901
First Submitted: December 23, 2009
First Posted: December 24, 2009
Results First Submitted: March 26, 2012
Results First Posted: September 25, 2012
Last Update Posted: September 25, 2012