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The purpose of this study is to compare the tolerability of MetroGel® (metronidazole gel) 1% to Finacea® (azelaic acid) Gel 15% in subjects with healthy skin applied according to product labeling for three weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| metronidazole 1% gel | Active Comparator |
| |
| azelaic acid 15% gel | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| metronidazole 1% gel | Drug | Apply topically on one side of the face once daily for three weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Were a Success With Regard to Worst Post-baseline Tolerability Assessment Scores in Each Assessment (Erythema, Scaling, Dryness, Stinging/Burning) From Baseline to Week 3 | Number of participants who were a success with regard to worst post-baseline tolerability assessment 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. | baseline to week 3 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ronald W Gottschalk, MD | Galderma R&D | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Thomas J. Stephens and Associates, Inc. | Carrollton | Texas | 75006 | United States |
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.
Dates of recruitment period: First subject was enrolled on June 7, 2010 and the last subject was enrolled on June 7, 2010.
Types of location: Investigative site was located at a research center.
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| ID | Title | Description |
|---|---|---|
| FG000 | MetroGel® 1% and Finacea 15% | This was a randomized split-face study where metronidazole gel 1% was applied topically to one side of the face once daily for 3 weeks and azelaic acid gel 15% was applied to the opposite side of the face twice daily for 3 weeks |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | MetroGel® 1% and Finacea® Gel 15% | This was a randomized split-face study where metronidazole gel 1% was applied topically to one side of the face once daily for 3 weeks and azelaic acid gel 15% was applied to the opposite side of the face twice daily for 3 weeks |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants Who Were a Success With Regard to Worst Post-baseline Tolerability Assessment Scores in Each Assessment (Erythema, Scaling, Dryness, Stinging/Burning) From Baseline to Week 3 | Number of participants who were a success with regard to worst post-baseline tolerability assessment 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. | Safety | Posted | Number | participants | baseline to week 3 |
|
3 weeks
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | MetroGel® 1% | metronidazole gel 1% - apply topically to one side of the face once daily for 3 weeks |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ronald W. Gottschalk, MD / Medical Director | Galderma Laboratories, L.P. | 817-961-5358 | ron.gottschalk@galderma.com |
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| ID | Term |
|---|---|
| D012877 | Skin Manifestations |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D008795 | Metronidazole |
| D005782 | Gels |
| C010038 | azelaic acid |
| ID | Term |
|---|---|
| D009593 | Nitroimidazoles |
| D009574 | Nitro Compounds |
| D009930 | Organic Chemicals |
| D007093 | Imidazoles |
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| azelaic acid 15% gel | Drug | Apply topically on the opposite side of the face twice daily for three weeks |
|
|
| Day 22 |
| 6 Question Subject Preference Survey at Week 3 | Number of participants per response to each question of the Subject Preference Survey at week 3 | week 3 |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 |
| Finacea® Gel 15% |
azelaic acid gel 15% - apply topically twice daily to the opposite side of the face |
|
|
| Secondary | 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. | 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. | Safety | Posted | Number | participants | Day 22 |
|
|
|
| Secondary | 6 Question Subject Preference Survey at Week 3 | Number of participants per response to each question of the Subject Preference Survey at week 3 | Safety | Posted | Number | participants | week 3 |
|
|
|
| 0 |
| 80 |
| 0 |
| 80 |
| EG001 | Finacea® Gel 15% | azelaic acid gel 15% - apply topically twice daily to the opposite side of the face | 0 | 80 | 0 | 80 |
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.
| D001393 |
| Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D003102 | Colloids |
| D045424 | Complex Mixtures |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
| Dryness |
|
| Stinging/Burning |
|
| Title | Measurements |
|---|---|
|
| 1. Side of face neither felt better |
|
| 1. Side of face Missing |
|
| 2. Overall impression of MetroGel® Very pleasant |
|
| 2. Overall impression of MetroGel® Pleasant |
|
| 2. Overall impression of MetroGel® Okay |
|
| 2. Overall impression of MetroGel® Unpleasant |
|
| 2. Overall impression of MetroGel® Very Unpleasant |
|
| 2. Overall impression of MetroGel® Missing |
|
| 3. Overall impression of Finacea® Very pleasant |
|
| 3. Overall impression of Finacea® Pleasant |
|
| 3. Overall impression of Finacea® Okay |
|
| 3. Overall impression of Finacea® Unpleasant |
|
| 3. Overall impression of Finacea® Very unpleasant |
|
| 3. Overall impression of Finacea® Missing |
|
| 4. Side of face more sensitive MetroGel® |
|
| 4. Side of face more sensitive Finacea® |
|
| 4. Side of face more sensitive both felt same |
|
| 4. Side of face more sensitive Neither |
|
| 4. Side of face more sensitive Missing |
|
| 5. Which side was easier to use MetroGel®? |
|
| 5. Which side was easier to use Finacea®? |
|
| 5. Which side was easier to use both equal? |
|
| 5. Which side was easier to use Neither? |
|
| 5. Which side was easier to use Missing |
|
| 6. Which product tell a friend about MetroGel®? |
|
| 6. Which product tell a friend about Finacea®? |
|
| 6. Which product tell a friend about Both? |
|
| 6. Which product tell a friend about Neither? |
|
| 6. Which product tell a friend about Missing |
|