Skin Manifestations
Conditions
Brief summary
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.
Interventions
Apply topically on one side of the face once daily for three weeks
Apply topically on the opposite side of the face twice daily for three weeks
Sponsors
Galderma R&D
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | week 3 | Number of participants per response to each question of the Subject Preference Survey at week 3 |
Countries
United States
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. Types of location: Investigative site was located at a research center.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 80 |
| Total | 80 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Non-compliant, lost product | 1 |
| Overall Study | Withdrawal by Subject | 5 |
Baseline characteristics
| Characteristic | MetroGel® 1% and Finacea® Gel 15% |
|---|---|
| Age, Continuous | 45 years STANDARD_DEVIATION 15.16 |
| Sex: Female, Male Female | 58 Participants |
| Sex: Female, Male Male | 22 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 80 | 0 / 80 |
| serious Total, serious adverse events | 0 / 80 | 0 / 80 |
Outcome results
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.
Time frame: baseline to week 3
Population: Safety
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MetroGel® 1% | 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 | Erythema | 14 participants |
| MetroGel® 1% | 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 | Dryness | 71 participants |
| MetroGel® 1% | 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 | Stinging/Burning | 72 participants |
| MetroGel® 1% | 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 | Scaling | 79 participants |
| Finacea® Gel 15% | 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 | Stinging/Burning | 65 participants |
| Finacea® Gel 15% | 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 | Erythema | 11 participants |
| Finacea® Gel 15% | 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 | Scaling | 78 participants |
| Finacea® Gel 15% | 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 | Dryness | 70 participants |
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
Time frame: week 3
Population: Safety
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MetroGel® 1% | 6 Question Subject Preference Survey at Week 3 | 6. Which product tell a friend about Finacea®? | 26 participants |
| MetroGel® 1% | 6 Question Subject Preference Survey at Week 3 | 6. Which product tell a friend about Both? | 25 participants |
| MetroGel® 1% | 6 Question Subject Preference Survey at Week 3 | 6. Which product tell a friend about Neither? | 11 participants |
| MetroGel® 1% | 6 Question Subject Preference Survey at Week 3 | 6. Which product tell a friend about Missing | 2 participants |
| MetroGel® 1% | 6 Question Subject Preference Survey at Week 3 | 1. Side of face felt better MetroGel® | 16 participants |
| MetroGel® 1% | 6 Question Subject Preference Survey at Week 3 | 1. Side of face felt better Finacea® | 20 participants |
| MetroGel® 1% | 6 Question Subject Preference Survey at Week 3 | 1. Side of face both felt same | 31 participants |
| MetroGel® 1% | 6 Question Subject Preference Survey at Week 3 | 1. Side of face neither felt better | 11 participants |
| MetroGel® 1% | 6 Question Subject Preference Survey at Week 3 | 1. Side of face Missing | 2 participants |
| MetroGel® 1% | 6 Question Subject Preference Survey at Week 3 | 2. Overall impression of MetroGel® Very pleasant | 16 participants |
| MetroGel® 1% | 6 Question Subject Preference Survey at Week 3 | 2. Overall impression of MetroGel® Pleasant | 25 participants |
| MetroGel® 1% | 6 Question Subject Preference Survey at Week 3 | 2. Overall impression of MetroGel® Okay | 32 participants |
| MetroGel® 1% | 6 Question Subject Preference Survey at Week 3 | 2. Overall impression of MetroGel® Unpleasant | 3 participants |
| MetroGel® 1% | 6 Question Subject Preference Survey at Week 3 | 2. Overall impression of MetroGel® Very Unpleasant | 2 participants |
| MetroGel® 1% | 6 Question Subject Preference Survey at Week 3 | 2. Overall impression of MetroGel® Missing | 2 participants |
| MetroGel® 1% | 6 Question Subject Preference Survey at Week 3 | 3. Overall impression of Finacea® Very pleasant | 15 participants |
| MetroGel® 1% | 6 Question Subject Preference Survey at Week 3 | 3. Overall impression of Finacea® Pleasant | 33 participants |
| MetroGel® 1% | 6 Question Subject Preference Survey at Week 3 | 3. Overall impression of Finacea® Okay | 25 participants |
| MetroGel® 1% | 6 Question Subject Preference Survey at Week 3 | 3. Overall impression of Finacea® Unpleasant | 4 participants |
| MetroGel® 1% | 6 Question Subject Preference Survey at Week 3 | 3. Overall impression of Finacea® Very unpleasant | 1 participants |
| MetroGel® 1% | 6 Question Subject Preference Survey at Week 3 | 3. Overall impression of Finacea® Missing | 2 participants |
| MetroGel® 1% | 6 Question Subject Preference Survey at Week 3 | 4. Side of face more sensitive MetroGel® | 12 participants |
| MetroGel® 1% | 6 Question Subject Preference Survey at Week 3 | 4. Side of face more sensitive Finacea® | 27 participants |
| MetroGel® 1% | 6 Question Subject Preference Survey at Week 3 | 4. Side of face more sensitive both felt same | 10 participants |
| MetroGel® 1% | 6 Question Subject Preference Survey at Week 3 | 4. Side of face more sensitive Neither | 29 participants |
| MetroGel® 1% | 6 Question Subject Preference Survey at Week 3 | 4. Side of face more sensitive Missing | 2 participants |
| MetroGel® 1% | 6 Question Subject Preference Survey at Week 3 | 5. Which side was easier to use MetroGel®? | 18 participants |
| MetroGel® 1% | 6 Question Subject Preference Survey at Week 3 | 5. Which side was easier to use Finacea®? | 21 participants |
| MetroGel® 1% | 6 Question Subject Preference Survey at Week 3 | 5. Which side was easier to use both equal? | 38 participants |
| MetroGel® 1% | 6 Question Subject Preference Survey at Week 3 | 5. Which side was easier to use Neither? | 1 participants |
| MetroGel® 1% | 6 Question Subject Preference Survey at Week 3 | 5. Which side was easier to use Missing | 2 participants |
| MetroGel® 1% | 6 Question Subject Preference Survey at Week 3 | 6. Which product tell a friend about MetroGel®? | 16 participants |
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.
Time frame: Day 22
Population: Safety
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MetroGel® 1% | 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. | Erythema | 34 participants |
| MetroGel® 1% | 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. | Scaling | 74 participants |
| MetroGel® 1% | 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. | Dryness | 73 participants |
| MetroGel® 1% | 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. | Stinging/Burning | 72 participants |
| Finacea® Gel 15% | 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. | Stinging/Burning | 68 participants |
| Finacea® Gel 15% | 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. | Dryness | 73 participants |
| Finacea® Gel 15% | 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. | Erythema | 29 participants |
| Finacea® Gel 15% | 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. | Scaling | 73 participants |