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Trial record 31 of 143 for:    acne AND erythema

Finacea 15% and Brimonidine 0.33% Gel in the Treatment of Rosacea - A Pilot Study

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ClinicalTrials.gov Identifier: NCT02147691
Recruitment Status : Completed
First Posted : May 28, 2014
Results First Posted : September 30, 2015
Last Update Posted : September 30, 2015
Sponsor:
Collaborator:
Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma
Information provided by (Responsible Party):
Leon Kircik, M.D., Derm Research, PLLC

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Investigator);   Primary Purpose: Treatment
Condition Acne Rosacea
Interventions Drug: Azelaic acid 15%
Drug: Brimonidine 0.33%
Enrollment 22
Recruitment Details Single site recruitment, private medical clinic.. Subjects 18 to 85 years of age with moderate to severe rosacea.Recruitment began May 2014 and ended November 2014.
Pre-assignment Details Subjects could be excluded if less than 18 years of age, who does not have moderate to severe rosacea as determined by the Investigator Global Assessment (IGA), who has not completed the specified washout for medications as outlined in the protocol or who has been in another investigational study within 30 days of the Baseline visit.
Arm/Group Title Finacea 15% Gel (Azelaic Acid 15%), Brimonidine 0.33 % Gel Brimonidine 0.33% Gel
Hide Arm/Group Description

Finacea 15% Gel (azelaic acid 15%) followed 30 minutes later with application of Brimonidine 0.33% Gel each morning to the face

Finacea 15 % Gel (azelaic acid 15%) each evening to the face

Azelaic acid 15%

Brimonidine 0.33%

Brimonidine 0.33% Gel applied to the face each morning

Brimonidine 0.33%

Period Title: Overall Study
Started 10 12
Completed 6 11
Not Completed 4 1
Reason Not Completed
Withdrawal by Subject             2             0
Adverse Event             2             0
Lost to Follow-up             0             1
Arm/Group Title Finacea 15% Gel (Azelaic Acid 15%), Brimonidine 15 % Gel Brimonidine 0.33% Gel Total
Hide Arm/Group Description

Finacea 15% Gel (azelaic acid 15%) followed 30 minutes later with application of Brimonidine 0.33% Gel each morning to the face

Finacea 15 % Gel (azelaic acid 15%) each evening to the face

Azelaic acid 15%

Brimonidine 0.33%

Brimonidine 0.33% Gel applied to the face each morning

Brimonidine 0.33%

Total of all reporting groups
Overall Number of Baseline Participants 10 12 22
Hide Baseline Analysis Population Description
subjects between 18 years and 85 years of age with moderate to severe rosacea
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 12 participants 22 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
6
  60.0%
11
  91.7%
17
  77.3%
>=65 years
4
  40.0%
1
   8.3%
5
  22.7%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 12 participants 22 participants
Female
9
  90.0%
9
  75.0%
18
  81.8%
Male
1
  10.0%
3
  25.0%
4
  18.2%
1.Primary Outcome
Title Investigator Global Assessment (IGA) at Baseline
Hide Description Assessment of rosacea on a scale of 0-4, 0 = clear, 1= almost clear, 2= mild, 3= moderate and 4 = severe
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
Only participants who were not lost to follow up or did not withdraw consent were included in the final analysis.
Arm/Group Title Finacea 15% Gel (Azelaic Acid 15%), Brimonidine 15 % Gel Brimonidine 0.33% Gel
Hide Arm/Group Description:

Finacea 15% Gel (azelaic acid 15%) followed 30 minutes later with application of Brimonidine 0.33% Gel each morning to the face

Finacea 15 % Gel (azelaic acid 15%) each evening to the face

Azelaic acid 15%

Brimonidine 0.33%

Brimonidine 0.33% Gel applied to the face each morning

Brimonidone 0.33%

Overall Number of Participants Analyzed 6 11
Mean (Standard Deviation)
Unit of Measure: units on a scale
3  (0) 3.1  (0.3)
2.Primary Outcome
Title IGA
Hide Description Assessment of rosacea on a scale of 0-4, 0 = clear, 1= almost clear, 2= mild, 3= moderate and 4 = severe
Time Frame Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Finacea 15% Gel (Azelaic Acid 15%), Brimonidine 15 % Gel Brimonidine 0.33% Gel
Hide Arm/Group Description:

Finacea 15% Gel (azelaic acid 15%) followed 30 minutes later with application of Brimonidine 0.33% Gel each morning to the face

Finacea 15 % Gel (azelaic acid 15%) each evening to the face

Azelaic acid 15%

Brimonidine 0.33%

Brimonidine 0.33% Gel applied to the face each morning

Brimonidone 0.33%

Overall Number of Participants Analyzed 6 11
Mean (Standard Deviation)
Unit of Measure: units on a scale
1.8  (0.9) 1.8  (0.8)
3.Primary Outcome
Title IGA
Hide Description Assessment of rosacea on a scale of 0-4, 0 = clear, 1= almost clear, 2= mild, 3= moderate and 4 = severe
Time Frame Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Finacea 15% Gel (Azelaic Acid 15%), Brimonidine 15 % Gel Brimonidine 0.33% Gel
Hide Arm/Group Description:

Finacea 15% Gel (azelaic acid 15%) followed 30 minutes later with application of Brimonidine 0.33% Gel each morning to the face

Finacea 15 % Gel (azelaic acid 15%) each evening to the face

Azelaic acid 15%

Brimonidine 0.33%

Brimonidine 0.33% Gel applied to the face each morning

Brimonidone 0.33%

Overall Number of Participants Analyzed 6 11
Mean (Standard Deviation)
Unit of Measure: units on a scale
1.6  (1.2) 1.8  (0.9)
4.Primary Outcome
Title IGA
Hide Description Assessment of rosacea on a scale of 0-4, 0 = clear, 1= almost clear, 2= mild, 3= moderate and 4 = severe
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Finacea 15% Gel (Azelaic Acid 15%), Brimonidine 15 % Gel Brimonidine 0.33% Gel
Hide Arm/Group Description:

Finacea 15% Gel (azelaic acid 15%) followed 30 minutes later with application of Brimonidine 0.33% Gel each morning to the face

Finacea 15 % Gel (azelaic acid 15%) each evening to the face

Azelaic acid 15%

Brimonidine 0.33%

Brimonidine 0.33% Gel applied to the face each morning

Brimonidone 0.33%

Overall Number of Participants Analyzed 6 11
Mean (Standard Deviation)
Unit of Measure: units on a scale
1.3  (1.1) 1.4  (0.9)
5.Secondary Outcome
Title Lesion Counts
Hide Description The number of inflammatory lesions (papules/pustules) will be counted using the whole face from the hairline edge to the mandibular line
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Finacea 15% Gel (Azelaic Acid 15%), Brimonidine 15 % Gel Brimonidine 0.33% Gel
Hide Arm/Group Description:

Finacea 15% Gel (azelaic acid 15%) followed 30 minutes later with application of Brimonidine 0.33% Gel each morning to the face

Finacea 15 % Gel (azelaic acid 15%) each evening to the face

Azelaic acid 15%

Brimonidine 0.33%

Brimonidine 0.33% Gel applied to the face each morning

Brimonidone 0.33%

Overall Number of Participants Analyzed 6 11
Mean (Standard Deviation)
Unit of Measure: lesions
3.3  (1.6) 4.5  (2.8)
6.Secondary Outcome
Title Clinician's Erythema Assessment
Hide Description Erythema will be graded on a scale of 0-4., 0 = none, 1 = mild, 2 = moderate, 3 = severe, 4 very severe. If erythema is much worse on one or several parts of the face, the grade for the worst area will be captured.
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Finacea 15% Gel (Azelaic Acid 15%), Brimonidine 15 % Gel Brimonidine 0.33% Gel
Hide Arm/Group Description:

Finacea 15% Gel (azelaic acid 15%) followed 30 minutes later with application of Brimonidine 0.33% Gel each morning to the face

Finacea 15 % Gel (azelaic acid 15%) each evening to the face

Azelaic acid 15%

Brimonidine 0.33%

Brimonidine 0.33% Gel applied to the face each morning

Brimonidone 0.33%

Overall Number of Participants Analyzed 6 11
Mean (Standard Deviation)
Unit of Measure: units on a scale
2.3  (0.5) 2.1  (0.3)
7.Secondary Outcome
Title Erythema Visual Analog Scale (VAS) Assessment (Subject)
Hide Description Subjects will self assess the level of erythema over the previous 24 period using a scale of None (0) through 10 (Unbearable)
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Finacea 15% Gel (Azelaic Acid 15%), Brimonidine 15 % Gel Brimonidine 0.33% Gel
Hide Arm/Group Description:

Finacea 15% Gel (azelaic acid 15%) followed 30 minutes later with application of Brimonidine 0.33% Gel each morning to the face

Finacea 15 % Gel (azelaic acid 15%) each evening to the face

Azelaic acid 15%

Brimonidine 0.33%

Brimonidine 0.33% Gel applied to the face each morning

Brimonidone 0.33%

Overall Number of Participants Analyzed 6 11
Mean (Standard Deviation)
Unit of Measure: units on a scale
5.5  (2.5) 5.6  (1.8)
8.Secondary Outcome
Title Dermatology Life Quality Index (DLQI)
Hide Description The DLQI is a self-administered questionnaire consisting of 10 questions that measure how much the individual's skin problem has affected their life in the past week. Score ranges 0 through 30, 0 being none and 30 worst possible.
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Finacea 15% Gel (Azelaic Acid 15%), Brimonidine 15 % Gel Brimonidine 0.33% Gel
Hide Arm/Group Description:

Finacea 15% Gel (azelaic acid 15%) followed 30 minutes later with application of Brimonidine 0.33% Gel each morning to the face

Finacea 15 % Gel (azelaic acid 15%) each evening to the face

Azelaic acid 15%

Brimonidine 0.33%

Brimonidine 0.33% Gel applied to the face each morning

Brimonidone 0.33%

Overall Number of Participants Analyzed 6 11
Mean (Standard Deviation)
Unit of Measure: units on a scale
2.6  (3.7) 2.9  (1.9)
9.Secondary Outcome
Title Lesion Count
Hide Description [Not Specified]
Time Frame Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Finacea 15% Gel (Azelaic Acid 15%), Brimonidine 15 % Gel Brimonidine 0.33% Gel
Hide Arm/Group Description:

Finacea 15% Gel (azelaic acid 15%) followed 30 minutes later with application of Brimonidine 0.33% Gel each morning to the face

Finacea 15 % Gel (azelaic acid 15%) each evening to the face

Azelaic acid 15%

Brimonidine 0.33%

Brimonidine 0.33% Gel applied to the face each morning

Brimonidone 0.33%

Overall Number of Participants Analyzed 6 11
Mean (Standard Deviation)
Unit of Measure: lesions
1.1  (1.2) 2.1  (2.9)
10.Secondary Outcome
Title Lesion Counts
Hide Description [Not Specified]
Time Frame Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Finacea 15% Gel (Azelaic Acid 15%), Brimonidine 15 % Gel Brimonidine 0.33% Gel
Hide Arm/Group Description:

Finacea 15% Gel (azelaic acid 15%) followed 30 minutes later with application of Brimonidine 0.33% Gel each morning to the face

Finacea 15 % Gel (azelaic acid 15%) each evening to the face

Azelaic acid 15%

Brimonidine 0.33%

Brimonidine 0.33% Gel applied to the face each morning

Brimonidone 0.33%

Overall Number of Participants Analyzed 6 11
Mean (Standard Deviation)
Unit of Measure: lesions
1.0  (1.4) 1.7  (2.1)
11.Secondary Outcome
Title Lesion Counts
Hide Description [Not Specified]
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Finacea 15% Gel (Azelaic Acid 15%), Brimonidine 15 % Gel Brimonidine 0.33% Gel
Hide Arm/Group Description:

Finacea 15% Gel (azelaic acid 15%) followed 30 minutes later with application of Brimonidine 0.33% Gel each morning to the face

Finacea 15 % Gel (azelaic acid 15%) each evening to the face

Azelaic acid 15%

Brimonidine 0.33%

Brimonidine 0.33% Gel applied to the face each morning

Brimonidone 0.33%

Overall Number of Participants Analyzed 6 11
Mean (Standard Deviation)
Unit of Measure: lesions
0.7  (1.3) 1.2  (1.3)
12.Secondary Outcome
Title Erythema
Hide Description Erythema as measured by the clinician on a scale of 0-4, 0 = no erythema, 1 = slight pinkness, 2 = moderate, definite redness, easily recognized, 3 = severe, marked erythema and 4 = very severe, fiery red
Time Frame Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Finacea 15% Gel (Azelaic Acid 15%), Brimonidine 15 % Gel Brimonidine 0.33% Gel
Hide Arm/Group Description:

Finacea 15% Gel (azelaic acid 15%) followed 30 minutes later with application of Brimonidine 0.33% Gel each morning to the face

Finacea 15 % Gel (azelaic acid 15%) each evening to the face

Azelaic acid 15%

Brimonidine 0.33%

Brimonidine 0.33% Gel applied to the face each morning

Brimonidone 0.33%

Overall Number of Participants Analyzed 6 11
Mean (Standard Deviation)
Unit of Measure: units on a scale
1.6  (0.7) 1.3  (0.7)
13.Secondary Outcome
Title Erythema
Hide Description Erythema as measured by the clinician on a scale of 0-4, 0 = no erythema, 1 = slight pinkness, 2 = moderate, definite redness, easily recognized, 3 = severe, marked erythema and 4 = very severe, fiery red
Time Frame Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Finacea 15% Gel (Azelaic Acid 15%), Brimonidine 15 % Gel Brimonidine 0.33% Gel
Hide Arm/Group Description:

Finacea 15% Gel (azelaic acid 15%) followed 30 minutes later with application of Brimonidine 0.33% Gel each morning to the face

Finacea 15 % Gel (azelaic acid 15%) each evening to the face

Azelaic acid 15%

Brimonidine 0.33%

Brimonidine 0.33% Gel applied to the face each morning

Brimonidone 0.33%

Overall Number of Participants Analyzed 6 11
Mean (Standard Deviation)
Unit of Measure: units on a scale
1.3  (0.8) 1.4  (0.7)
14.Secondary Outcome
Title Erythema
Hide Description Erythema as measured by the clinician on a scale of 0-4, 0 = no erythema, 1 = slight pinkness, 2 = moderate, definite redness, easily recognized, 3 = severe, marked erythema and 4 = very severe, fiery red
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Finacea 15% Gel (Azelaic Acid 15%), Brimonidine 15 % Gel Brimonidine 0.33% Gel
Hide Arm/Group Description:

Finacea 15% Gel (azelaic acid 15%) followed 30 minutes later with application of Brimonidine 0.33% Gel each morning to the face

Finacea 15 % Gel (azelaic acid 15%) each evening to the face

Azelaic acid 15%

Brimonidine 0.33%

Brimonidine 0.33% Gel applied to the face each morning

Brimonidone 0.33%

Overall Number of Participants Analyzed 6 11
Mean (Standard Deviation)
Unit of Measure: units on a scale
1.3  (0.7) 1.2  (0.8)
15.Secondary Outcome
Title Visual Analog Scale (VAS)
Hide Description participant measures erythema on a scale of 0 mm to 10 mm with 0 = to none and 10 = unbearable
Time Frame Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Finacea 15% Gel (Azelaic Acid 15%), Brimonidine 15 % Gel Brimonidine 0.33% Gel
Hide Arm/Group Description:

Finacea 15% Gel (azelaic acid 15%) followed 30 minutes later with application of Brimonidine 0.33% Gel each morning to the face

Finacea 15 % Gel (azelaic acid 15%) each evening to the face

Azelaic acid 15%

Brimonidine 0.33%

Brimonidine 0.33% Gel applied to the face each morning

Brimonidone 0.33%

Overall Number of Participants Analyzed 6 11
Mean (Standard Deviation)
Unit of Measure: units on a scale
4.5  (2.4) 5.2  (2.1)
16.Secondary Outcome
Title VAS
Hide Description participant measures erythema on a scale of 0 mm to 10 mm with 0 = to none and 10 = unbearable
Time Frame Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Finacea 15% Gel (Azelaic Acid 15%), Brimonidine 15 % Gel Brimonidine 0.33% Gel
Hide Arm/Group Description:

Finacea 15% Gel (azelaic acid 15%) followed 30 minutes later with application of Brimonidine 0.33% Gel each morning to the face

Finacea 15 % Gel (azelaic acid 15%) each evening to the face

Azelaic acid 15%

Brimonidine 0.33%

Brimonidine 0.33% Gel applied to the face each morning

Brimonidone 0.33%

Overall Number of Participants Analyzed 6 11
Mean (Standard Deviation)
Unit of Measure: units on a scale
4.4  (3.0) 4.5  (2.1)
17.Secondary Outcome
Title VAS
Hide Description participant measures erythema on a scale of 0 mm to 10 mm with 0 = to none and 10 = unbearable
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Finacea 15% Gel (Azelaic Acid 15%), Brimonidine 15 % Gel Brimonidine 0.33% Gel
Hide Arm/Group Description:

Finacea 15% Gel (azelaic acid 15%) followed 30 minutes later with application of Brimonidine 0.33% Gel each morning to the face

Finacea 15 % Gel (azelaic acid 15%) each evening to the face

Azelaic acid 15%

Brimonidine 0.33%

Brimonidine 0.33% Gel applied to the face each morning

Brimonidone 0.33%

Overall Number of Participants Analyzed 6 11
Mean (Standard Deviation)
Unit of Measure: units on a scale
3.8  (2.3) 4.0  (2.1)
18.Secondary Outcome
Title Dermatology Life Quality Index (DLQI)
Hide Description Total scores range from 0 ( no impact on life over the last week) to 30 (maximum impact on life over the last week)
Time Frame Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Finacea 15% Gel (Azelaic Acid 15%), Brimonidine 15 % Gel Brimonidine 0.33% Gel
Hide Arm/Group Description:

Finacea 15% Gel (azelaic acid 15%) followed 30 minutes later with application of Brimonidine 0.33% Gel each morning to the face

Finacea 15 % Gel (azelaic acid 15%) each evening to the face

Azelaic acid 15%

Brimonidine 0.33%

Brimonidine 0.33% Gel applied to the face each morning

Brimonidone 0.33%

Overall Number of Participants Analyzed 6 11
Mean (Standard Deviation)
Unit of Measure: units on a scale
1.8  (1.5) 2.6  (2.0)
19.Secondary Outcome
Title DLQI
Hide Description Total scores range from 0 ( no impact on life over the last week) to 30 (maximum impact on life over the last week)
Time Frame Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Finacea 15% Gel (Azelaic Acid 15%), Brimonidine 15 % Gel Brimonidine 0.33% Gel
Hide Arm/Group Description:

Finacea 15% Gel (azelaic acid 15%) followed 30 minutes later with application of Brimonidine 0.33% Gel each morning to the face

Finacea 15 % Gel (azelaic acid 15%) each evening to the face

Azelaic acid 15%

Brimonidine 0.33%

Brimonidine 0.33% Gel applied to the face each morning

Brimonidone 0.33%

Overall Number of Participants Analyzed 6 11
Mean (Standard Deviation)
Unit of Measure: units on a scale
1.3  (1.2) 2.6  (2.6)
20.Secondary Outcome
Title DLQI
Hide Description Total scores range from 0 ( no impact on life over the last week) to 30 (maximum impact on life over the last week)
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Finacea 15% Gel (Azelaic Acid 15%), Brimonidine 15 % Gel Brimonidine 0.33% Gel
Hide Arm/Group Description:

Finacea 15% Gel (azelaic acid 15%) followed 30 minutes later with application of Brimonidine 0.33% Gel each morning to the face

Finacea 15 % Gel (azelaic acid 15%) each evening to the face

Azelaic acid 15%

Brimonidine 0.33%

Brimonidine 0.33% Gel applied to the face each morning

Brimonidone 0.33%

Overall Number of Participants Analyzed 6 11
Mean (Standard Deviation)
Unit of Measure: units on a scale
1.2  (1.2) 2.8  (2.8)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Finacea 15% Gel (Azelaic Acid 15%), Brimonidine 15 % Gel Brimonidine 0.33% Gel
Hide Arm/Group Description

Finacea 15% Gel (azelaic acid 15%) followed 30 minutes later with application of Brimonidine 0.33% Gel each morning to the face

Finacea 15 % Gel (azelaic acid 15%) each evening to the face

Azelaic acid 15%

Brimonidine 0.33%

Brimonidine 0.33% Gel applied to the face each morning

Brimonidone 0.33%

All-Cause Mortality
Finacea 15% Gel (Azelaic Acid 15%), Brimonidine 15 % Gel Brimonidine 0.33% Gel
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Finacea 15% Gel (Azelaic Acid 15%), Brimonidine 15 % Gel Brimonidine 0.33% Gel
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/10 (0.00%)      0/12 (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 15% Gel (Azelaic Acid 15%), Brimonidine 15 % Gel Brimonidine 0.33% Gel
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/10 (30.00%)      4/12 (33.33%)    
Musculoskeletal and connective tissue disorders     
pulled muscle * [1]  0/10 (0.00%)  0 1/12 (8.33%)  1
Broken toe * [2]  1/10 (10.00%)  1 0/12 (0.00%)  0
Renal and urinary disorders     
urinary tract infection *  1/10 (10.00%)  1 0/12 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
common cold *  1/10 (10.00%)  1 0/12 (0.00%)  0
sinus infection *  1/10 (10.00%)  1 0/12 (0.00%)  0
bronchitis *  1/10 (10.00%)  1 0/12 (0.00%)  0
pneumonia *  1/10 (10.00%)  1 0/12 (0.00%)  0
Skin and subcutaneous tissue disorders     
worsening erythema on face * [3]  0/10 (0.00%)  0 1/12 (8.33%)  1
worsening facial lesions * [3]  0/10 (0.00%)  0 1/12 (8.33%)  1
herpes simplex * [4]  0/10 (0.00%)  0 1/12 (8.33%)  1
burning at application site *  1/10 (10.00%)  1 0/12 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
[1]
right hip
[2]
Left fourth toe
[3]
treatment area
[4]
Adjacent to treatment area
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Leon H. Kircik, M.D.
Organization: DermResearch, PLLC
Phone: 502-451-9000
Responsible Party: Leon Kircik, M.D., Derm Research, PLLC
ClinicalTrials.gov Identifier: NCT02147691     History of Changes
Other Study ID Numbers: FIN1302
First Submitted: May 16, 2014
First Posted: May 28, 2014
Results First Submitted: May 7, 2015
Results First Posted: September 30, 2015
Last Update Posted: September 30, 2015