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Trial record 58 of 233 for:    acne AND Percent

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
Enrollment 20
Recruitment Details Subjects recruited from private office population.
Pre-assignment Details  
Arm/Group Title Finacea
Hide Arm/Group Description Open label pilot study. All subjects were given Azelaic acid 15% to be used topically, twice daily.
Period Title: Overall Study
Started 20
Completed 13
Not Completed 7
Reason Not Completed
Withdrawal by Subject             1
Lost to Follow-up             6
Arm/Group Title Finacea
Hide Arm/Group Description Open label pilot study
Overall Number of Baseline Participants 20
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
<=18 years
8
  40.0%
Between 18 and 65 years
12
  60.0%
>=65 years
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 20 participants
24  (10.63)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
Female
15
  75.0%
Male
5
  25.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 20 participants
20
1.Primary Outcome
Title Percentage of Participants With Improvement in Acne IGA (Investigator Global Assessment)
Hide Description IGA Assessments at each visit (baseline and follow up) based on a 6 point scale (0= clear through 5 = very severe). Improvement is defined as at least a 1 point improvement.
Time Frame Baseline to 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol
Arm/Group Title Azelaic Acid 15% Open Label
Hide Arm/Group Description:
Assessments of IGA
Overall Number of Participants Analyzed 20
Measure Type: Number
Unit of Measure: percentage of participants
92
2.Secondary Outcome
Title Percentage of Participants With Improvement in the IGA of Post Inflammatory Hyperpigmentation(PIH)
Hide Description IGA for PIH assessed on a 7 point scale (0= clear through 6 = severe) with at least a two point improvement
Time Frame Baseline to16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
per protocol
Arm/Group Title Azelaic Acis 15% Open Label
Hide Arm/Group Description:
Assessments of PIH IGA
Overall Number of Participants Analyzed 20
Measure Type: Number
Unit of Measure: percentage of participants
100
3.Secondary Outcome
Title Percentage of Participants With an Improvement in Post Inflammatory Hyperpigmentation (PIH) % Distribution
Hide Description The % distribution of PIH, evaluated on a scale of 0 = no PIH through 6 = greater than 50%
Time Frame Baseline to 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
per protocol
Arm/Group Title Azelaic Acid 15%
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 20
Measure Type: Number
Unit of Measure: percentage of participants
2 grade improvement 92
1 grade improvement 100
4.Secondary Outcome
Title Percentage Change in Total Lesion Counts
Hide Description Total lesions including inflammatory lesions (papules, pustules, nodules) and non-inflammatory lesions (open and closed comedones).
Time Frame Baseline to 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
per protocol
Arm/Group Title Azelaic Acid 15%
Hide Arm/Group Description:
lesion counts
Overall Number of Participants Analyzed 20
Mean (Standard Deviation)
Unit of Measure: percentage of total lesion count
-92.4  (10.4)
5.Secondary Outcome
Title Tolerability Assessments as Measured by the Number of Participants With Side Effects
Hide Description Tolerability parameters assesssed by the presence and degree of peeling, erythema, dryness, oiliness, burning and pruritus
Time Frame 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
per protocol
Arm/Group Title Azelaic Acid 15%
Hide Arm/Group Description:
tolerability assessments
Overall Number of Participants Analyzed 20
Measure Type: Number
Unit of Measure: participants
0
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Finacea
Hide Arm/Group Description Open label pilot study
All-Cause Mortality
Finacea
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Finacea
Affected / at Risk (%)
Total   0/20 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Finacea
Affected / at Risk (%)
Total   0/20 (0.00%) 
This is an open-label study with a small number of subjects.
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
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