Split-face Tolerability Comparison Between MetroGel® 1% vs Finacea® 15% in Subjects With Healthy Skin
Study Details
Study Description
Brief Summary
The purpose of this study is to compare the tolerability of MetroGel® 1% to Finacea® 15% in subjects with healthy skin applied according to product labeling for three weeks.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 4 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Active Comparator: metronidazole 1% gel
|
Drug: metronidazole 1% gel
Apply topically once daily on one side of the face for three weeks
Other Names:
|
Active Comparator: azelaic acid 15% gel
|
Drug: azelaic acid 15% gel
Apply topically twice daily on the opposite side of the face for three weeks
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Number of Participants Who Were a Success With Regard to Worst Post-baseline Tolerability Scores in Each Assessment (Erythema, Scaling, Dryness, Stinging/Burning) From Baseline to Week 3 [baseline to week 3]
Number of participants who were a success with regard to worst post-baseline tolerability scores in each of the tolerability assessments at any time point between baseline and week 3. Tolerability assessments (erythema, scaling, dryness, stinging/burning) are evaluated on a scale from 0 - 4 (0 = None, 1 = Mild, 2 = Moderate, 3 = Severe) with 0 being best and 4 being worst. Success was defined as a tolerability score of 0.
Secondary Outcome Measures
- Number of Participants Who Were a Success With Regard to Worst-baseline Tolerability Assessment Scores in Each Assessment (Erythema, Scaling, Dryness, Stinging/Burning) on Day 22 [day 22]
Number of participants who were a success with regard to worst-baseline tolerability assessment scores for each assessment (erythema, scaling, dryness, stinging/burning) on day 22. Tolerability assessments (erythema, scaling, dryness, stinging/burning) are evaluated on a scale from 0 - 4 (0 = None, 1 = Mild, 2 = Moderate, 3 = Severe) with 0 being best and 4 being worst. Success was defined as a tolerability score of 0 for each assessment.
- 6 Question Subject Preference Survey at Week 3 [3 weeks]
Number of participants per response to each question of the subject preference survey at week 3
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Healthy male and female adults (ages 18 years or older)
-
Subjects with healthy skin as determined by the clinical grader
Exclusion Criteria:
-
Subjects with a degree of skin pigmentation that interferes with the reading of skin reactions
-
Subjects with known allergy to one of the components of the study drugs (refer to the package inserts for MetroGel® 1% and Finacea® Gel 15%)
-
Subjects who have participated in another investigational drug or device research study within 30 days of enrollment
-
Subjects with a washout period for topical treatment on the treated area less than 1 week for corticosteroids and/or 4 weeks for retinoids
-
Subjects with a washout period for systemic treatment less than 1 week for medications that may increase photosensitivity and/or 4 weeks for corticosteroids and/or 6 months for retinoids
-
Subjects with current sunburn, eczema, atopic dermatitis, perioral dermatitis, rosacea, or other topical conditions on the area to be treated
-
Subjects who foresee unprotected and intense UV exposure during the study (mountain sports, UV radiation, sunbathing, etc.)
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Thomas J. Stephens & Associates, Inc. | Colorado Springs | Colorado | United States | 80915 |
Sponsors and Collaborators
- Galderma R&D
Investigators
- Study Director: Ronald W Gottschalk, MD, Galderma R&D
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- US10160
Study Results
Participant Flow
Recruitment Details | Dates of recruitment period: First subject was enrolled on June 7, 2010 and the last subject was enrolled on June 7, 2010. |
---|---|
Pre-assignment Detail | Wash-out period up to baseline for topical treatment on the treated area was less than 1 week for corticosteroids and/or 4 weeks for retinoids; for systemic treatment less than 1 week for medications that may increase photosensitivity and/or 4 weeks for corticosteroids and/or 6 months for retinoids. |
Arm/Group Title | MetroGel® 1% and Finacea® Gel 15% |
---|---|
Arm/Group Description | This was a randomized split-face study where MetroGel®(metronidazole gel) 1% was applied topically to one side of the face once daily for 3 weeks and Finacea® (azelaic acid) gel 15% was applied to the opposite side of the face twice daily for 3 weeks |
Period Title: Overall Study | |
STARTED | 77 |
COMPLETED | 76 |
NOT COMPLETED | 1 |
Baseline Characteristics
Arm/Group Title | MetroGel® 1% and Finacea® Gel 15% |
---|---|
Arm/Group Description | This was a randomized split-face study where MetroGel®(metronidazole gel) 1% was applied topically to one side of the face once daily for 3 weeks and Finacea® (azelaic acid) gel 15% was applied to the opposite side of the face twice daily for 3 weeks |
Overall Participants | 77 |
Age (years) [Mean (Standard Deviation) ] | |
Mean (Standard Deviation) [years] |
42.4
(15.07)
|
Sex: Female, Male (Count of Participants) | |
Female |
61
79.2%
|
Male |
16
20.8%
|
Outcome Measures
Title | Number of Participants Who Were a Success With Regard to Worst Post-baseline Tolerability Scores in Each Assessment (Erythema, Scaling, Dryness, Stinging/Burning) From Baseline to Week 3 |
---|---|
Description | Number of participants who were a success with regard to worst post-baseline tolerability scores in each of the tolerability assessments at any time point between baseline and week 3. Tolerability assessments (erythema, scaling, dryness, stinging/burning) are evaluated on a scale from 0 - 4 (0 = None, 1 = Mild, 2 = Moderate, 3 = Severe) with 0 being best and 4 being worst. Success was defined as a tolerability score of 0. |
Time Frame | baseline to week 3 |
Outcome Measure Data
Analysis Population Description |
---|
Safety |
Arm/Group Title | MetroGel® 1% | Finacea Gel® 15% |
---|---|---|
Arm/Group Description | metronidazole gel 1% - apply topically to one side of the face once daily for 3 weeks | azelaic acid 15 % gel - apply topically to the opposite side of the face twice daily for 3 weeks |
Measure Participants | 77 | 77 |
Erythema |
12
15.6%
|
13
NaN
|
Scaling |
61
79.2%
|
60
NaN
|
Dryness |
48
62.3%
|
48
NaN
|
Stinging/Burning |
65
84.4%
|
34
NaN
|
Title | Number of Participants Who Were a Success With Regard to Worst-baseline Tolerability Assessment Scores in Each Assessment (Erythema, Scaling, Dryness, Stinging/Burning) on Day 22 |
---|---|
Description | Number of participants who were a success with regard to worst-baseline tolerability assessment scores for each assessment (erythema, scaling, dryness, stinging/burning) on day 22. Tolerability assessments (erythema, scaling, dryness, stinging/burning) are evaluated on a scale from 0 - 4 (0 = None, 1 = Mild, 2 = Moderate, 3 = Severe) with 0 being best and 4 being worst. Success was defined as a tolerability score of 0 for each assessment. |
Time Frame | day 22 |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | MetroGel® 1% | Finacea Gel® 15% |
---|---|---|
Arm/Group Description | metronidazole gel 1% - apply topically to one side of the face once daily for 3 weeks | azelaic acid 15 % gel - apply topically to the opposite side of the face twice daily for 3 weeks |
Measure Participants | 77 | 77 |
Erythema |
33
42.9%
|
33
NaN
|
Scaling |
69
89.6%
|
71
NaN
|
Dryness |
50
64.9%
|
51
NaN
|
Stinging/Burning |
77
100%
|
63
NaN
|
Title | 6 Question Subject Preference Survey at Week 3 |
---|---|
Description | Number of participants per response to each question of the subject preference survey at week 3 |
Time Frame | 3 weeks |
Outcome Measure Data
Analysis Population Description |
---|
Safety |
Arm/Group Title | MetroGel® 1% and Finacea Gel® 15% |
---|---|
Arm/Group Description | This was a randomized split-face study where metronidazole 1% gel was applied to one side of the face once daily for 3 weeks and azelaic acid 15 % gel was applied to the opposite side of the face twice daily for 3 weeks |
Measure Participants | 77 |
1. Side of face felt better MetroGel® |
21
27.3%
|
1. Side of face felt better Finacea® |
14
18.2%
|
1. Side of face both felt same |
30
39%
|
1. Side of face neither felt better |
12
15.6%
|
1. Side of face felt better Missing |
0
0%
|
2. Overall impression of MetroGel® Very pleasant |
3
3.9%
|
2. Overall impression of MetroGel® Pleasant |
36
46.8%
|
2. Overall impression of MetroGel® Okay |
34
44.2%
|
2. Overall impression of MetroGel® Unpleasant |
4
5.2%
|
2. Overall impression of MetroGel® Very unpleasant |
0
0%
|
2. Overall impression of MetroGel® Missing |
0
0%
|
3. Overall impression of Finacea® Very pleasant |
5
6.5%
|
3. Overall impression of Finacea® Pleasant |
26
33.8%
|
3. Overall impression of Finacea® Okay |
38
49.4%
|
3. Overall impression of Finacea® Unpleasant |
5
6.5%
|
3. Overall impression of Finacea® Very unpleasant |
3
3.9%
|
3. Overall impression of Finacea® Missing |
0
0%
|
4. Side of face more sensitive MetroGel® |
4
5.2%
|
4. Side of face more sensitive Finacea® |
32
41.6%
|
4. Side of face more sensitive both felt same |
12
15.6%
|
4. Side of face more sensitive Neither |
29
37.7%
|
4. Side of face more sensitive Missing |
0
0%
|
5. Which side was easier to use MetroGel®? |
13
16.9%
|
5. Which side was easier to use Finacea®? |
13
16.9%
|
5. Which side was easier to use both equal? |
50
64.9%
|
5. Which side was easier to use Neither? |
1
1.3%
|
5. Which side was easier to use Missing |
0
0%
|
6. Which product tell a friend about MetroGel®? |
13
16.9%
|
6. Which product tell a friend about Finacea®? |
11
14.3%
|
6. Which product tell a friend about Both? |
32
41.6%
|
6. Which product tell a friend about Neither? |
21
27.3%
|
6. Which product tell a friend about Missing? |
0
0%
|
Adverse Events
Time Frame | 3 weeks | |||
---|---|---|---|---|
Adverse Event Reporting Description | Subjects were asked if there had been any change in their health at each study visit; information obtained was recorded as adverse event(s), if applicable. | |||
Arm/Group Title | MetroGel® 1% | Finacea® Gel 15% | ||
Arm/Group Description | metronidazole gel 1% - apply topically to one side of the face once daily for 3 weeks | azelaic acid gel 15% - apply topically to the opposite side of the face twice daily for 3 weeks | ||
All Cause Mortality |
||||
MetroGel® 1% | Finacea® Gel 15% | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
MetroGel® 1% | Finacea® Gel 15% | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/77 (0%) | 0/77 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
MetroGel® 1% | Finacea® Gel 15% | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/77 (0%) | 6/77 (7.8%) | ||
General disorders | ||||
application site pruritus | 0/77 (0%) | 0 | 6/77 (7.8%) | 6 |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
The principal investigator has the right to publish or present the data resulting from this study, with agreed upon reviews by all interested parties, and in accordance with any confidentiality agreements that may exist.
Results Point of Contact
Name/Title | Ronald W. Gottschalk, MD / Medical Director |
---|---|
Organization | Galderma Laboratories, L.P. |
Phone | 817-961-5358 |
ron.gottschalk@galderma.com |
- US10160