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A Randomized, Evaluator-Blinded, Bilateral Comparison Study to Evaluate the Safety and Efficacy of Two Topicals in the Treatment of Subjects With Acne Vulgaris (Study FX2018-23).
A Randomized, Evaluator-Blinded, Bilateral Comparison Study to Evaluate the Safety and Efficacy of Two Topicals in the Treatment of Subjects With Acne Vulgaris. Eligible subjects will be randomized (1:1) to treatment with Test Article A to one side of the face versus Test Article B on the contralateral side.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FMX101 vehicle | Experimental | FMX101 hydrophobic oil based vehicle (Test Article A) topically applied daily for six weeks on one side of the face (in a split-face model) |
|
| Hydro-alcohol solution base | Experimental | Hydro-alcohol solution based vehicle (Test Article B) topically applied daily for six weeks on the contralateral side of the face (in a split-face model) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FMX101 vehicle | Drug | FMX101 vehicle - hydrophobic oil based vehicle (Test Article A) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With 0 to 4 Investigator's Global Assessment Score at Week 6 | Severity of acne vulgaris was assessed by Investigator Global Assessment (IGA). The IGA score is a static evaluation of the overall severity or "average" degree of severity of a participant's disease by the Blinded Evaluator taking into account all of the participant's facial acne lesions as the participant appears on the day of the evaluation. Overall severity of acne was assessed using a five-point scale where 0=Clear, 1=Almost Clear, 2=Mild, 3=Moderate, and 4=Severe. Low score represented best outcome and higher score value indicated worst outcome. | At Week 6 |
| Number of Participants Achieving Investigator's Global Assessments Treatment Success at Week 6 | Severity of acne vulgaris was assessed by IGA. The IGA score is a static evaluation of the overall severity or "average" degree of severity of a participant's disease by the Blinded Evaluator taking into account all of the participant's facial acne lesions as the participant appears on the day of the evaluation. Overall severity of acne was assessed using a five-point scale where 0=Clear, 1=Almost Clear, 2=Mild, 3=Moderate, and 4=Severe. The IGA treatment "success" was defined as at least a two-point improvement in IGA score relative to Baseline. | At Week 6 |
| Absolute Change From Baseline to Week 6 in Inflammatory Lesion Count | Inflammatory lesion count (ILC) included papules (raised inflammatory lesions with no visible purulent material) and pustules (raised inflammatory lesions with visible purulent material). | Day 1/ Baseline and Week 6 |
| Percentage Change From Baseline to Week 6 in Inflammatory Lesion Count | The ILC included papules (raised inflammatory lesions with no visible purulent material) and pustules (raised inflammatory lesions with visible purulent material). | Day 1/ Baseline and Week 6 |
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Inclusion Criteria:
Has facial acne vulgaris with:
16 inflammatory lesions (papules, pustules) The inflammatory lesion count on the right and left side of the face should be similar IGA score of moderate (3) on both the right and left side of the face
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site #01 | San Diego | California | 92123 | United States |
The study consisted of a Screening/Baseline Visit, Visits at Weeks 1, 2, and 4, along with a Week 6/End of Treatment (EOT) Visit, and a Week 7/End of Study (EOS) Visit. All participants underwent inclusion and exclusion criteria assessment and all eligible participants signed the informed consent before undergoing any study related procedures. All assessments at screening were done as per the schedule of assessment.
Study was conducted in one site at United States from November 20, 2018 to February 11, 2019.
| ID | Title | Description |
|---|---|---|
| FG000 | Overall | Participants were randomized (1:1) and applied FMX101 hydrophobic oil based vehicle (Test Article A) topically on one side of the face and Hydro-alcohol solution based vehicle (Test Article B) on the contralateral side of the face once daily for six weeks. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Modified intent-to-treat (mITT) population included all randomized participants who met all Inclusion/Exclusion criteria, applied at least one dose of test article, and returned for at least one post-Baseline evaluation visit.
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall | Participants were randomized (1:1) and applied FMX101 hydrophobic oil based vehicle (Test Article A) topically on one side of the face and Hydro-alcohol solution based vehicle (Test Article B) on the contralateral side of the face once daily for six weeks on one 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 | Number of Participants With 0 to 4 Investigator's Global Assessment Score at Week 6 | Severity of acne vulgaris was assessed by Investigator Global Assessment (IGA). The IGA score is a static evaluation of the overall severity or "average" degree of severity of a participant's disease by the Blinded Evaluator taking into account all of the participant's facial acne lesions as the participant appears on the day of the evaluation. Overall severity of acne was assessed using a five-point scale where 0=Clear, 1=Almost Clear, 2=Mild, 3=Moderate, and 4=Severe. Low score represented best outcome and higher score value indicated worst outcome. | The mITT population included all randomized participants who met all Inclusion/Exclusion criteria, applied at least one dose of test article, and returned for at least one post-Baseline evaluation visit. Here, overall number of participants analyzed presents only those participants who were analyzed for this particular outcome measure, and number analyzed presents the number of participants that were analyzed at specified week. | Posted | Number | Participants | At Week 6 | Face sides | Face sides |
|
Day 1 until Week 7 (End of Study) or Unscheduled Visit
Adverse Events were only monitored/assessed on the whole participant level.
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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 | Overall | Participants were randomized (1:1) and applied FMX101 hydrophobic oil based vehicle (Test Article A) topically on one side of the face and Hydro-alcohol solution based vehicle (Test Article B) on the contralateral side of the face once daily for six weeks. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastroenteritis Viral | Gastrointestinal disorders | MedDRA 21.1 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Iain Stuart, PhD. | Foamix Pharmaceuticals, Inc. | 1 800-775-7936 | Iain.Stuart@foamix.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 13, 2018 | Jan 7, 2021 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 7, 2019 | Jan 7, 2021 | SAP_001.pdf |
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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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| ID | Term |
|---|---|
| D008911 | Minocycline |
| D000431 | Ethanol |
| D012996 | Solutions |
| ID | Term |
|---|---|
| D013754 | Tetracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
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Eligible subjects will be randomized (1:1) to treatment with Test Article A to one side of the face versus Test Article B on the contralateral side.
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| Hydro-alcohol solution | Other | Hydro-alcohol solution based vehicle (Test Article B) |
|
|
| Absolute Change From Baseline to Week 6 in Non-Inflammatory Lesion Count |
The non-inflammatory lesion count (NILC) included open and closed comedones. |
| Day 1/ Baseline and Week 6 |
| Percentage Change From Baseline to Week 6 in Non-Inflammatory Lesion Count | The NILC included open and closed comedones. | Day 1/ Baseline and Week 6 |
| Change in Sebum Percentage Relative to Baseline Versus Weeks 2, 4, 6 and 7 | Sebum measurement was conducted on the right and left side of the face. The sebum measurement represented the sebum score of saturation of the film and had a range of 0 to 99, where 99 equated to very oily skin. | Day 1/Baseline and Weeks 2, 4, 6 and 7 |
| Change in Transepidermal Water Loss Relative to Baseline Versus Weeks 2, 4, 6 and 7 | Transepidermal Water Loss (TEWL) was conducted on the right and left side of the face. | Day 1/Baseline and Weeks 2, 4, 6 and 7 |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) | An adverse event is any untoward medical occurrence associated with the use of a drug in participants, whether or not considered drug related. | Day 1 until Week 7 (End of Study) and Unscheduled Visit |
| Number of Participants Having Local Skin Reactions With Improved/Same Versus Worsened Severities Compared to Baseline | The local skin reactions (LSRs) included erythema, edema, scaling/dryness, burning/stinging, pruritus, erosion, and pain) were assessed. Erythema, edema, scaling/dryness, and erosion were assessed by the investigator and burning/stinging, pain, and pruritus were assessed by the participant. Assessments was made using a 4-point ordinal scale where 0=absent, 1=mild (slight, barely perceptible), 2=moderate (distinct presence), and 3=severe (marked, intense). Here, lower point represented no reaction and higher points represented severe reactions.The LSRs were assessed both before and 15 minutes following test article application. | Day 1 until Week 7 (End of Study) or Unscheduled Visit |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Description |
|---|
| OG000 | FMX101 Oil Vehicle (A) | Participants applied FMX101 hydrophobic oil based vehicle (Test Article A) topically once daily for six weeks on one side of the face. |
| OG001 | Hydro-alcohol Vehicle (B) | Participants applied Hydro-alcohol solution based vehicle (Test Article B) topically once daily for six weeks on the contralateral side of the face. |
|
|
| Primary | Number of Participants Achieving Investigator's Global Assessments Treatment Success at Week 6 | Severity of acne vulgaris was assessed by IGA. The IGA score is a static evaluation of the overall severity or "average" degree of severity of a participant's disease by the Blinded Evaluator taking into account all of the participant's facial acne lesions as the participant appears on the day of the evaluation. Overall severity of acne was assessed using a five-point scale where 0=Clear, 1=Almost Clear, 2=Mild, 3=Moderate, and 4=Severe. The IGA treatment "success" was defined as at least a two-point improvement in IGA score relative to Baseline. | The mITT population included all randomized participants who met all Inclusion/Exclusion criteria, applied at least one dose of test article, and returned for at least one post-Baseline evaluation visit. Here, overall number of participants analyzed presents only those participants who were analyzed for this particular outcome measure. | Posted | Number | Participants | At Week 6 | Face sides | Face sides |
|
|
|
| Primary | Absolute Change From Baseline to Week 6 in Inflammatory Lesion Count | Inflammatory lesion count (ILC) included papules (raised inflammatory lesions with no visible purulent material) and pustules (raised inflammatory lesions with visible purulent material). | The mITT population included all randomized participants who met all Inclusion/Exclusion criteria, applied at least one dose of test article, and returned for at least one post-Baseline evaluation visit. Here, overall number of participants analyzed presents only those participants who were analyzed for this particular outcome measure. | Posted | Mean | Standard Deviation | Lesions | Day 1/ Baseline and Week 6 | Face sides | Face sides |
|
|
|
| Primary | Percentage Change From Baseline to Week 6 in Inflammatory Lesion Count | The ILC included papules (raised inflammatory lesions with no visible purulent material) and pustules (raised inflammatory lesions with visible purulent material). | The mITT population included all randomized participants who met all Inclusion/Exclusion criteria, applied at least one dose of test article, and returned for at least one post-Baseline evaluation visit. Here, overall number of participants analyzed presents only those participants who were analyzed for this particular outcome measure. | Posted | Mean | Standard Deviation | Percent Change | Day 1/ Baseline and Week 6 | Face sides | Face sides |
|
|
|
| Primary | Absolute Change From Baseline to Week 6 in Non-Inflammatory Lesion Count | The non-inflammatory lesion count (NILC) included open and closed comedones. | The mITT population included all randomized participants who met all Inclusion/Exclusion criteria, applied at least one dose of test article, and returned for at least one post-Baseline evaluation visit. Here, overall number of participants analyzed presents only those participants who were analyzed for this particular outcome measure. | Posted | Mean | Standard Deviation | Lesions | Day 1/ Baseline and Week 6 | Face sides | Face sides |
|
|
|
| Primary | Percentage Change From Baseline to Week 6 in Non-Inflammatory Lesion Count | The NILC included open and closed comedones. | The mITT population included all randomized participants who met all Inclusion/Exclusion criteria, applied at least one dose of test article, and returned for at least one post-Baseline evaluation visit. Here, overall number of participants analyzed presents only those participants who were analyzed for this particular outcome measure. | Posted | Mean | Standard Deviation | Percent Change | Day 1/ Baseline and Week 6 | Face sides | Face sides |
|
|
|
| Primary | Change in Sebum Percentage Relative to Baseline Versus Weeks 2, 4, 6 and 7 | Sebum measurement was conducted on the right and left side of the face. The sebum measurement represented the sebum score of saturation of the film and had a range of 0 to 99, where 99 equated to very oily skin. | The mITT population included all randomized participants who met all Inclusion/Exclusion criteria, applied at least one dose of test article, and returned for at least one post-Baseline evaluation visit. Here, overall number of participants analyzed presents only those participants who were analyzed for this particular outcome measure, and number analyzed presents the number of participants that were analyzed at specified week. | Posted | Mean | Standard Deviation | Percentage (%) | Day 1/Baseline and Weeks 2, 4, 6 and 7 | Face sides | Face sides |
|
|
|
| Primary | Change in Transepidermal Water Loss Relative to Baseline Versus Weeks 2, 4, 6 and 7 | Transepidermal Water Loss (TEWL) was conducted on the right and left side of the face. | The mITT population included all randomized participants who met all Inclusion/Exclusion criteria, applied at least one dose of test article, and returned for at least one post-Baseline evaluation visit. Here, overall number of participants analyzed presents only those participants who were analyzed for this particular outcome measure, and number analyzed presents the number of participants that were analyzed at specified week. | Posted | Mean | Standard Deviation | g/m^2 /h | Day 1/Baseline and Weeks 2, 4, 6 and 7 | Face sides | Face sides |
|
|
|
| Primary | Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) | An adverse event is any untoward medical occurrence associated with the use of a drug in participants, whether or not considered drug related. | Safety population included all randomized participants who received test article and applied at least one application. | Posted | Number | Participants | Day 1 until Week 7 (End of Study) and Unscheduled Visit |
|
|
|
| Primary | Number of Participants Having Local Skin Reactions With Improved/Same Versus Worsened Severities Compared to Baseline | The local skin reactions (LSRs) included erythema, edema, scaling/dryness, burning/stinging, pruritus, erosion, and pain) were assessed. Erythema, edema, scaling/dryness, and erosion were assessed by the investigator and burning/stinging, pain, and pruritus were assessed by the participant. Assessments was made using a 4-point ordinal scale where 0=absent, 1=mild (slight, barely perceptible), 2=moderate (distinct presence), and 3=severe (marked, intense). Here, lower point represented no reaction and higher points represented severe reactions.The LSRs were assessed both before and 15 minutes following test article application. | Safety population included all randomized participants who received test article and applied at least one application. Here, overall number of participants analyzed presents only those participants who were analyzed for particular outcome measure, and number analyzed presents the number of participants that were analyzed at specified week. | Posted | Count of Participants | Participants | Day 1 until Week 7 (End of Study) or Unscheduled Visit |
|
|
|
| 0 |
| 12 |
| 0 |
| 12 |
| 5 |
| 12 |
| Influenza | Infections and infestations | MedDRA 21.1 | Non-systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA 21.1 | Non-systematic Assessment |
|
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA 21.1 | Non-systematic Assessment |
|
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| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D000438 | Alcohols |
| D004364 | Pharmaceutical Preparations |
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| Week 4 |
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| Week 6 |
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| Week 7 |
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| Week 4 |
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| Week 6 |
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| Week 7 |
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| Title | Measurements |
|---|---|
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| Serious TEAEs |
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| Erythema, Week 1 (Worsened) |
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| Erythema, Week 2 (Improved/Same) |
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| Erythema, Week 2 (Worsened) |
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| Erythema, Week 4 (Improved/Same) |
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| Erythema, Week 4 (Worsened) |
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| Erythema, Week 6 (Improved/Same) |
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| Erythema, Week 6 (Worsened) |
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| Erythema, Week 7 (Improved/Same) |
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| Erythema, Week 7 (Worsened) |
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| Edema, Week 1 (Improved/Same) |
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| Edema, Week 1 (Worsened) |
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| Edema, Week 2 (Improved/Same) |
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| Edema, Week 2 (Worsened) |
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| Edema, Week 4 (Improved/Same) |
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| Edema, Week 4 (Worsened) |
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| Edema, Week 6 (Improved/Same) |
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| Edema, Week 6 (Worsened) |
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| Edema, Week 7 (Improved/Same) |
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| Edema, Week 7 (Worsened) |
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| Scaling/Dryness, Week 1 (Improved/Same) |
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| Scaling/Dryness, Week 1 (Worsened) |
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| Scaling/Dryness, Week 2 (Improved/Same) |
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| Scaling/Dryness, Week 2 (Worsened) |
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| Scaling/Dryness, Week 4 (Improved/Same) |
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| Scaling/Dryness, Week 4 (Worsened) |
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| Scaling/Dryness, Week 6 (Improved/Same) |
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| Scaling/Dryness, Week 6 (Worsened) |
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| Scaling/Dryness, Week 7 (Improved/Same) |
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| Scaling/Dryness, Week 7 (Worsened) |
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| Erosion, Week 1 (Improved/Same) |
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| Erosion, Week 1 (Worsened) |
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| Erosion, Week 2 (Improved/Same) |
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| Erosion, Week 2 (Worsened) |
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| Erosion, Week 4 (Improved/Same) |
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| Erosion, Week 4 (Worsened) |
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| Erosion, Week 6 (Improved/Same) |
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| Erosion, Week 6 (Worsened) |
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| Erosion, Week 7 (Improved/Same) |
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| Erosion, Week 7 (Worsened) |
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| Burning/Stinging, Week 1 (Improved/Same) |
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| Burning/Stinging, Week 1 (Worsened) |
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| Burning/Stinging, Week 2 (Improved/Same) |
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| Burning/Stinging, Week 2 (Worsened) |
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| Burning/Stinging, Week 4 (Improved/Same) |
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| Burning/Stinging, Week 4 (Worsened) |
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| Burning/Stinging, Week 6 (Improved/Same) |
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| Burning/Stinging, Week 6 (Worsened) |
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| Burning/Stinging, Week 7 (Improved/Same) |
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| Burning/Stinging, Week 7 (Worsened) |
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| Pain, Week 1 (Improved/Same) |
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| Pain, Week 1 (Worsened) |
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| Pain, Week 2 (Improved/Same) |
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| Pain, Week 2 (Worsened) |
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| Pain, Week 4 (Improved/Same) |
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| Pain, Week 4 (Worsened) |
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| Pain, Week 6 (Improved/Same) |
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| Pain, Week 6 (Worsened) |
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| Pain, Week 7 (Improved/Same) |
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| Pain, Week 7 (Worsened) |
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| Pruritus, Week 1 (Improved/Same) |
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| Pruritus, Week 1 (Worsened) |
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| Pruritus, Week 2 (Improved/Same) |
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| Pruritus, Week 2 (Worsened) |
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| Pruritus, Week 4 (Improved/Same) |
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| Pruritus, Week 4 (Worsened) |
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| Pruritus, Week 6 (Improved/Same) |
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| Pruritus, Week 6 (Worsened) |
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| Pruritus, Week 7 (Improved/Same) |
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| Pruritus, Week 7 (Worsened) |
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