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To compare the tolerability of Epiduo® (adapalene and benzoyl peroxide) Gel 0.1%/2.5% to Retin-A Micro® (tretinoin gel) microsphere when used by subjects with acne vulgaris for 3 weeks in terms of local tolerability parameters (erythema, dryness, scaling, stinging/burning) and preference.
Adult subjects with acne vulgaris will receive tretinoin gel 0.1% on one side of the face and adapalene 0.1% / benzoyl peroxide 2.5% gel on the other side of the face once daily for a period 3 weeks (22 days). Tolerability assessments (erythema, dryness, scaling, stinging/burning)on both sides of the face will be taken on each visit, on each weekday from from baseline to day 22. The investigator and subjects will respond to user preference questions on days 5, 12, 19, and 22.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Epiduo Gel | Active Comparator | Adapalene 0.1% and benzoyl peroxide 2.5% gel |
|
| Retin-A Micro Microsphere 0.1% | Active Comparator | Tretinoin gel, 0.1% |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Epiduo Gel | Drug | Once-daily application of fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% in an aqueous based gel. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Worst Postbaseline Tolerability (Erythema) | Worst postbaseline tolerability assessment for erythema. | Day 1 - Day 22 |
| Worst Postbaseline Tolerability (Scaling) | Worst postbaseline assessment for scaling. | Day 1 - Day 22 |
| Worst Postbaseline Tolerability (Dryness) | Worst postbaseline tolerability assessments for dryness. | Day 1 - Day 22 |
| Worst Postbaseline Tolerability (Stinging/Burning) | Worst postbaseline tolerability assessments for stinging/burning | Day 1 - Day 22 |
| Measure | Description | Time Frame |
|---|---|---|
| Tolerability at Day 22 (Erythema) | Tolerability assessments at day 22 for erythema | Day 22 |
| Tolerability at Day 22 (Dryness) | Tolerability assessments at day 22 for dryness |
| Measure | Description | Time Frame |
|---|---|---|
| User Preference Survey (Investigator) | Response from investigator when asked: "Which side of the face appears to be less irritated?" Data collected from available participants. | Day 5, day 12, day 19, and day 22 |
| User Preference Survey (Subjects) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ronald Gottschalk, MD | Galderma R&D | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stephens and Associates | Dallas | Texas | 75006 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Total Participants | All subjects randomized into the trial who received Epiduo Gel and Retin-A Micro 0.1% gel on each side of the face |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Total Participants | All subjects randomized into the trial who received Epiduo Gel and Retin-A Micro 0.1% gel on each side of the face |
| 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 | Worst Postbaseline Tolerability (Erythema) | Worst postbaseline tolerability assessment for erythema. | Safety population | Posted | Number | participants | Day 1 - Day 22 |
|
Day 1 - Day 22
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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 | Epiduo Gel | Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% gel Epiduo Gel : Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% in an aqueous based gel. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Epilepsy | Nervous system disorders | MedDRA 14.0 | Non-systematic Assessment | Epileptic seizure not related to study medicines. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dry Skin | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Elizabeth M. Nieman, Associate Medical Information Specialist | Galderma Laboratories, L.P. | 817-961-5130 | elizabeth.nieman@galderma.com |
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| ID | Term |
|---|---|
| D000152 | Acne Vulgaris |
| ID | Term |
|---|---|
| D017486 | Acneiform Eruptions |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012625 | Sebaceous Gland Diseases |
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| Retin-A Micro Microsphere 0.1% | Drug | Once-daily application of tretinoin gel, 0.1% by weight, in a formulation of porous microspheres in an aqueous gel. |
|
| Day 22 |
| Tolerability at Day 22 (Scaling) | Tolerability assessments at day 22 for scaling | Day 22 |
| Tolerability at Day 22 (Stinging/Burning) | Tolerability assessments at day 22 for stinging/burning | Day 22 |
| Cumulative Tolerability (Erythema) | Cumulative tolerability assessments for erythema. Cumulative tolerability is defined as the sum of the tolerability scores for erythema. Tolerability was assessed on a 4-point categorical scale(0=none, 1=mild, 2=moderate, 3=severe) for all subjects at each visit. | Day 1 - Day 22 |
| Cumulative Tolerability (Scaling) | Cumulative tolerability assessments for scaling. Cumulative tolerability is defined as the sum of the tolerability scores for scaling. Tolerability was assessed on a 4-point categorical scale(0=none, 1=mild, 2=moderate, 3=severe) for all subjects at each visit. | Day 1 - Day 22 |
| Cumulative Tolerability (Dryness) | Cumulative tolerability assessments for dryness. Cumulative tolerability is defined as the sum of the tolerability scores for dryness. Tolerability was assessed on a 4-point categorical scale(0=none, 1=mild, 2=moderate, 3=severe) for all subjects at each visit. | Day 1 - Day 22 |
| Cumulative Tolerability (Stinging/Burning) | Cumulative tolerability assessments for stinging/burning. Cumulative tolerability is defined as the sum of the tolerability scores stinging/burning. Tolerability was assessed on a 4-point categorical scale(0=none, 1=mild, 2=moderate, 3=severe) for all subjects at each visit. | Day 1 - Day 22 |
| Cumulative Tolerability (Combined) | Cumulative tolerability assessments for erythema, scaling, dryness, and stinging/burning. Cumulative tolerability is defined as the sum of the tolerability scores for erythema, scaling, dryness, or stinging/burning. Tolerability was assessed on a 4-point categorical scale(0=none, 1=mild, 2=moderate, 3=severe) for all subjects at each visit. | Day 1 - Day 22 |
Response from subjects when asked: "Which side of the face feels less irritated?" Data collected from available participants on each assessment day.
| Day 5, day 12, day 19, and day 22 |
| Overall Tolerability Preference Survey | Overall tolerability preference survey taken by the subjects. Data collected from available subjects on day 22. | Day 22 |
| Pregnancy |
|
| Tolerability Assessment |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Tolerability at Day 22 (Erythema) | Tolerability assessments at day 22 for erythema | Safety population | Posted | Number | participants | Day 22 |
|
|
|
| Secondary | Tolerability at Day 22 (Dryness) | Tolerability assessments at day 22 for dryness | Safety population | Posted | Number | participants | Day 22 |
|
|
|
| Other Pre-specified | User Preference Survey (Investigator) | Response from investigator when asked: "Which side of the face appears to be less irritated?" Data collected from available participants. | Safety population | Posted | Number | participants | Day 5, day 12, day 19, and day 22 |
|
|
|
| Other Pre-specified | User Preference Survey (Subjects) | Response from subjects when asked: "Which side of the face feels less irritated?" Data collected from available participants on each assessment day. | Safety population | Posted | Number | participants | Day 5, day 12, day 19, and day 22 |
|
|
|
| Primary | Worst Postbaseline Tolerability (Scaling) | Worst postbaseline assessment for scaling. | Safety population | Posted | Number | participants | Day 1 - Day 22 |
|
|
|
| Primary | Worst Postbaseline Tolerability (Dryness) | Worst postbaseline tolerability assessments for dryness. | Safety population | Posted | Number | participants | Day 1 - Day 22 |
|
|
|
| Secondary | Tolerability at Day 22 (Scaling) | Tolerability assessments at day 22 for scaling | Safety population | Posted | Number | participants | Day 22 |
|
|
|
| Primary | Worst Postbaseline Tolerability (Stinging/Burning) | Worst postbaseline tolerability assessments for stinging/burning | Safety population | Posted | Number | participants | Day 1 - Day 22 |
|
|
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| Secondary | Tolerability at Day 22 (Stinging/Burning) | Tolerability assessments at day 22 for stinging/burning | Safety population | Posted | Number | participants | Day 22 |
|
|
|
| Secondary | Cumulative Tolerability (Erythema) | Cumulative tolerability assessments for erythema. Cumulative tolerability is defined as the sum of the tolerability scores for erythema. Tolerability was assessed on a 4-point categorical scale(0=none, 1=mild, 2=moderate, 3=severe) for all subjects at each visit. | Safety population | Posted | Number | scores on a scale | Day 1 - Day 22 |
|
|
|
| Secondary | Cumulative Tolerability (Scaling) | Cumulative tolerability assessments for scaling. Cumulative tolerability is defined as the sum of the tolerability scores for scaling. Tolerability was assessed on a 4-point categorical scale(0=none, 1=mild, 2=moderate, 3=severe) for all subjects at each visit. | Safety population | Posted | Number | scores on a scale | Day 1 - Day 22 |
|
|
|
| Secondary | Cumulative Tolerability (Dryness) | Cumulative tolerability assessments for dryness. Cumulative tolerability is defined as the sum of the tolerability scores for dryness. Tolerability was assessed on a 4-point categorical scale(0=none, 1=mild, 2=moderate, 3=severe) for all subjects at each visit. | Safety population | Posted | Number | scores on a scale | Day 1 - Day 22 |
|
|
|
| Secondary | Cumulative Tolerability (Stinging/Burning) | Cumulative tolerability assessments for stinging/burning. Cumulative tolerability is defined as the sum of the tolerability scores stinging/burning. Tolerability was assessed on a 4-point categorical scale(0=none, 1=mild, 2=moderate, 3=severe) for all subjects at each visit. | Safety population | Posted | Number | scores on a scale | Day 1 - Day 22 |
|
|
|
| Secondary | Cumulative Tolerability (Combined) | Cumulative tolerability assessments for erythema, scaling, dryness, and stinging/burning. Cumulative tolerability is defined as the sum of the tolerability scores for erythema, scaling, dryness, or stinging/burning. Tolerability was assessed on a 4-point categorical scale(0=none, 1=mild, 2=moderate, 3=severe) for all subjects at each visit. | Safety population | Posted | Number | scores on a scale | Day 1 - Day 22 |
|
|
|
| Other Pre-specified | Overall Tolerability Preference Survey | Overall tolerability preference survey taken by the subjects. Data collected from available subjects on day 22. | Safety population | Posted | Number | participants | Day 22 |
|
|
|
| Post-Hoc | Fitzpatrick Skin Type Worst Postbaseline Tolerability Assessment (Erythema) | Worst Postbaseline Tolerability Assessment Grouped by Fitzpatrick Skin Type for Erythema. Fitzpatrick skin type is a numerical classification scale for the color of skin from Type 1 to Type VI. Skin type 1 = always burns and never tans (light, pale skin) and skin type VI = never burns, tans very easily, and is deeply pigmented (black, very dark brown to black skin). | Safety Population | Posted | Number | participants | Day 1 - Day 22 |
|
|
|
| Post-Hoc | Fitzpatrick Skin Type Worst Postbaseline Tolerability Assessment (Scaling) | Worst Postbaseline Tolerability Assessment Grouped by Fitzpatrick Skin Type for Scaling. Fitzpatrick skin type is a numerical classification scale for the color of skin from Type 1 to Type VI. Skin type 1 = always burns and never tans (light, pale skin) and skin type VI = never burns, tans very easily, and is deeply pigmented (black, very dark brown to black skin). | Safety Population | Posted | Number | participants | Day 1 - Day 22 |
|
|
|
| Post-Hoc | Fitzpatrick Skin Type Worst Postbaseline Tolerability Assessment (Dryness) | Worst Postbaseline Tolerability Assessment Grouped by Fitzpatrick Skin Type for Dryness. Fitzpatrick skin type is a numerical classification scale for the color of skin from Type 1 to Type VI. Skin type 1 = always burns and never tans (light, pale skin) and skin type VI = never burns, tans very easily, and is deeply pigmented (black, very dark brown to black skin). | Safety Population | Posted | Number | participants | Day 1 - Day 22 |
|
|
|
| Post-Hoc | Fitzpatrick Skin Type Worst Postbaseline Tolerability Assessment (Stinging/Burning) | Worst Postbaseline Tolerability Assessment Grouped by Fitzpatrick Skin Type for Stinging/Burning. Fitzpatrick skin type is a numerical classification scale for the color of skin from Type 1 to Type VI. Skin type 1 = always burns and never tans (light, pale skin) and skin type VI = never burns, tans very easily, and is deeply pigmented (black, very dark brown to black skin). | Safety Population | Posted | Number | participants | Day 1 - Day 22 |
|
|
|
| Post-Hoc | Fitzpatrick Skin Type User Preference Survey at Day 22 | User Preference Survey at Day 22 (Safety Population) Grouped by Fitzpatrick Skin Type. Fitzpatrick skin type (FST) is a numerical classification scale for the color of skin from Type 1 to Type VI. Skin type 1 = always burns and never tans (light, pale skin) and skin type VI = never burns, tans very easily, and is deeply pigmented (black, very dark brown to black skin). Two subjects did not participate in the User Preference Survey; as a result, 2 subjects were not included in the FST I - III group results below. | Posted | Number | participants | Day 22 |
|
|
|
| Post-Hoc | Fitzpatrick Skin Type Overall Tolerability Preference Survey Results | Overall Tolerability Preference Survey Results at Day 22 (Safety Population) Grouped by Fitzpatrick Skin Type (FST). Data collected from available subjects on day 22. Fitzpatrick skin type is a numerical classification scale for the color of skin from Type 1 to Type VI. Skin type 1 = always burns and never tans (light, pale skin) and skin type VI = never burns, tans very easily, and is deeply pigmented (black, very dark brown to black skin). One subject did not participate in the User Preference Survey; as a result, 1 subject was not included in the FST I - III group results below. | Posted | Number | participants | Day 22 |
|
|
|
| 0 |
| 73 |
| 16 |
| 73 |
| EG001 | Retin-A Micro Microsphere 0.1% | Tretinoin gel, 0.1% Retin-A Micro Microsphere 0.1% : Tretinoin gel, 0.1% by weight, in a formulation of porous microspheres in an aqueous gel. | 0 | 73 | 16 | 73 |
| EG002 | Non-application Site | Adverse events occurring on non-application sites | 1 | 73 | 0 | 73 |
|
| Skin Burning Sensation | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Non-systematic Assessment |
|
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| Moderate |
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| Severe |
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| Data Missing |
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| Moderate |
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| Severe |
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| Data Missing |
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| Day 19 (n=65) |
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| Day 22 (n=72) |
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| Day 19 (n=65) |
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| Day 22 (n=72) |
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| Moderate |
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| Severe |
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| Moderate |
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| Severe |
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| Moderate |
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| Severe |
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| Data Missing |
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| Moderate |
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| Severe |
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| Moderate |
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| Severe |
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| Data Missing |
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| 3 |
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| 4 |
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| 5 |
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| 8 |
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| 9 |
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| 10 |
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| 11 |
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| 12 |
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| 15 |
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| 16 |
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| 17 |
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| 18 |
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| 19 |
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| 22 |
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| 3 |
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| 4 |
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| 5 |
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| 8 |
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| 9 |
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| 10 |
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| 11 |
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| 12 |
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| 15 |
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| 16 |
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| 17 |
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| 18 |
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| 19 |
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| 22 |
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| 3 |
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| 4 |
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| 5 |
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| 8 |
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| 9 |
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| 10 |
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| 11 |
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| 12 |
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| 15 |
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| 16 |
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| 17 |
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| 18 |
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| 19 |
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| 22 |
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| 3 |
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| 4 |
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| 5 |
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| 8 |
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| 9 |
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| 10 |
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| 11 |
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| 12 |
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| 15 |
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| 16 |
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| 17 |
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| 18 |
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| 19 |
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| 22 |
|
| 3 |
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| 4 |
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| 5 |
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| 8 |
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| 9 |
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| 10 |
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| 11 |
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| 12 |
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| 15 |
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| 16 |
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| 17 |
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| 18 |
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| 19 |
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| 22 |
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| ____ had a more pleasant smell (n=71) |
|
| ____ felt better on my skin (n=71) |
|
| ____ left smaller amount of residue on skin (n=71) |
|
| Overall, I prefer ____ (n=71) |
|
| Mild |
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| Moderate |
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| Severe |
|
| Mild |
|
| Moderate |
|
| Mild |
|
| Moderate |
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| Mild |
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| Moderate |
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| Severe |
|
| Absorbed more quickly |
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| Smelled better |
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| Felt better |
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| Left less residue |
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| Overall |
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| Overall tolerability preference - subject |
|