Acne Vulgaris
Conditions
Brief summary
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).
Detailed description
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.
Interventions
DRUGFMX101 vehicle
FMX101 vehicle - hydrophobic oil based vehicle (Test Article A)
OTHERHydro-alcohol solution
Hydro-alcohol solution based vehicle (Test Article B)
Sponsors
Vyne Therapeutics Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
12 Years to 40 Years
Healthy volunteers
No
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
* Acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne), or any dermatological condition of the face or facial hair (eg, beard, sideburns, mustache) that could interfere with the clinical evaluations. * More than two facial nodules/cysts * Sunburn on the face
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With 0 to 4 Investigator's Global Assessment Score at Week 6 | 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. |
| Number of Participants Achieving Investigator's Global Assessments Treatment Success at Week 6 | 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. |
| Absolute Change From Baseline to Week 6 in Inflammatory Lesion Count | Day 1/ Baseline and Week 6 | Inflammatory lesion count (ILC) included papules (raised inflammatory lesions with no visible purulent material) and pustules (raised inflammatory lesions with visible purulent material). |
| Percentage Change From Baseline to Week 6 in Inflammatory Lesion Count | Day 1/ Baseline and Week 6 | The ILC included papules (raised inflammatory lesions with no visible purulent material) and pustules (raised inflammatory lesions with visible purulent material). |
| Absolute Change From Baseline to Week 6 in Non-Inflammatory Lesion Count | Day 1/ Baseline and Week 6 | The non-inflammatory lesion count (NILC) included open and closed comedones. |
| Percentage Change From Baseline to Week 6 in Non-Inflammatory Lesion Count | Day 1/ Baseline and Week 6 | The NILC included open and closed comedones. |
| Change in Sebum Percentage Relative to Baseline Versus Weeks 2, 4, 6 and 7 | Day 1/Baseline and 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. |
| Change in Transepidermal Water Loss Relative to Baseline Versus Weeks 2, 4, 6 and 7 | Day 1/Baseline and Weeks 2, 4, 6 and 7 | Transepidermal Water Loss (TEWL) was conducted on the right and left side of the face. |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) | Day 1 until Week 7 (End of Study) and Unscheduled Visit | An adverse event is any untoward medical occurrence associated with the use of a drug in participants, whether or not considered drug related. |
| Number of Participants Having Local Skin Reactions With Improved/Same Versus Worsened Severities Compared to Baseline | Day 1 until Week 7 (End of Study) or Unscheduled Visit | 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. |
Countries
United States
Participant flow
Recruitment details
Study was conducted in one site at United States from November 20, 2018 to February 11, 2019.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 12 |
| Total | 12 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Physician Decision | 1 |
Baseline characteristics
| Characteristic | Overall |
|---|---|
| Age, Continuous | 20.1 Years STANDARD_DEVIATION 5.24 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 5 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 7 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 10 Participants |
| Sex: Female, Male Female | 6 Participants |
| Sex: Female, Male Male | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 12 |
| other Total, other adverse events | 5 / 12 |
| serious Total, serious adverse events | 0 / 12 |
Outcome results
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).
Time frame: Day 1/ Baseline and Week 6
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| FMX101 Oil Vehicle (A) | Absolute Change From Baseline to Week 6 in Inflammatory Lesion Count | -7.5 Lesions | Standard Deviation 8.26 |
| Hydro-alcohol Vehicle (B) | Absolute Change From Baseline to Week 6 in Inflammatory Lesion Count | -6.3 Lesions | Standard Deviation 4.2 |
Primary
Absolute Change From Baseline to Week 6 in Non-Inflammatory Lesion Count
The non-inflammatory lesion count (NILC) included open and closed comedones.
Time frame: Day 1/ Baseline and Week 6
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| FMX101 Oil Vehicle (A) | Absolute Change From Baseline to Week 6 in Non-Inflammatory Lesion Count | -7.0 Lesions | Standard Deviation 5.06 |
| Hydro-alcohol Vehicle (B) | Absolute Change From Baseline to Week 6 in Non-Inflammatory Lesion Count | -5.0 Lesions | Standard Deviation 4.36 |
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.
Time frame: Day 1/Baseline and Weeks 2, 4, 6 and 7
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| FMX101 Oil Vehicle (A) | Change in Sebum Percentage Relative to Baseline Versus Weeks 2, 4, 6 and 7 | Week 2 | 1.6 Percentage (%) | Standard Deviation 13.28 |
| FMX101 Oil Vehicle (A) | Change in Sebum Percentage Relative to Baseline Versus Weeks 2, 4, 6 and 7 | Week 6 | 3.9 Percentage (%) | Standard Deviation 8.88 |
| FMX101 Oil Vehicle (A) | Change in Sebum Percentage Relative to Baseline Versus Weeks 2, 4, 6 and 7 | Week 4 | 6.0 Percentage (%) | Standard Deviation 13.96 |
| FMX101 Oil Vehicle (A) | Change in Sebum Percentage Relative to Baseline Versus Weeks 2, 4, 6 and 7 | Week 7 | -1.9 Percentage (%) | Standard Deviation 8.24 |
| Hydro-alcohol Vehicle (B) | Change in Sebum Percentage Relative to Baseline Versus Weeks 2, 4, 6 and 7 | Week 7 | -1.5 Percentage (%) | Standard Deviation 7.57 |
| Hydro-alcohol Vehicle (B) | Change in Sebum Percentage Relative to Baseline Versus Weeks 2, 4, 6 and 7 | Week 2 | -2.5 Percentage (%) | Standard Deviation 5.89 |
| Hydro-alcohol Vehicle (B) | Change in Sebum Percentage Relative to Baseline Versus Weeks 2, 4, 6 and 7 | Week 4 | 5.2 Percentage (%) | Standard Deviation 8.14 |
| Hydro-alcohol Vehicle (B) | Change in Sebum Percentage Relative to Baseline Versus Weeks 2, 4, 6 and 7 | Week 6 | 1.9 Percentage (%) | Standard Deviation 5.63 |
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.
Time frame: Day 1/Baseline and Weeks 2, 4, 6 and 7
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| FMX101 Oil Vehicle (A) | Change in Transepidermal Water Loss Relative to Baseline Versus Weeks 2, 4, 6 and 7 | Week 2 | 2.8 g/m^2 /h | Standard Deviation 7.12 |
| FMX101 Oil Vehicle (A) | Change in Transepidermal Water Loss Relative to Baseline Versus Weeks 2, 4, 6 and 7 | Week 4 | 1.3 g/m^2 /h | Standard Deviation 6.86 |
| FMX101 Oil Vehicle (A) | Change in Transepidermal Water Loss Relative to Baseline Versus Weeks 2, 4, 6 and 7 | Week 6 | -0.7 g/m^2 /h | Standard Deviation 7.92 |
| FMX101 Oil Vehicle (A) | Change in Transepidermal Water Loss Relative to Baseline Versus Weeks 2, 4, 6 and 7 | Week 7 | 0.8 g/m^2 /h | Standard Deviation 6.28 |
| Hydro-alcohol Vehicle (B) | Change in Transepidermal Water Loss Relative to Baseline Versus Weeks 2, 4, 6 and 7 | Week 7 | -1.7 g/m^2 /h | Standard Deviation 7.29 |
| Hydro-alcohol Vehicle (B) | Change in Transepidermal Water Loss Relative to Baseline Versus Weeks 2, 4, 6 and 7 | Week 2 | -0.4 g/m^2 /h | Standard Deviation 5.62 |
| Hydro-alcohol Vehicle (B) | Change in Transepidermal Water Loss Relative to Baseline Versus Weeks 2, 4, 6 and 7 | Week 6 | -0.6 g/m^2 /h | Standard Deviation 7.24 |
| Hydro-alcohol Vehicle (B) | Change in Transepidermal Water Loss Relative to Baseline Versus Weeks 2, 4, 6 and 7 | Week 4 | -1.2 g/m^2 /h | Standard Deviation 6.46 |
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.
Time frame: At Week 6
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| FMX101 Oil Vehicle (A) | Number of Participants Achieving Investigator's Global Assessments Treatment Success at Week 6 | 3 Participants |
| Hydro-alcohol Vehicle (B) | Number of Participants Achieving Investigator's Global Assessments Treatment Success at Week 6 | 3 Participants |
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.
Time frame: Day 1 until Week 7 (End of Study) or Unscheduled Visit
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| FMX101 Oil Vehicle (A) | Number of Participants Having Local Skin Reactions With Improved/Same Versus Worsened Severities Compared to Baseline | Edema, Week 6 (Worsened) | 0 Participants |
| FMX101 Oil Vehicle (A) | Number of Participants Having Local Skin Reactions With Improved/Same Versus Worsened Severities Compared to Baseline | Erythema, Week 1 (Improved/Same) | 9 Participants |
| FMX101 Oil Vehicle (A) | Number of Participants Having Local Skin Reactions With Improved/Same Versus Worsened Severities Compared to Baseline | Edema, Week 7 (Improved/Same) | 11 Participants |
| FMX101 Oil Vehicle (A) | Number of Participants Having Local Skin Reactions With Improved/Same Versus Worsened Severities Compared to Baseline | Pain, Week 6 (Worsened) | 0 Participants |
| FMX101 Oil Vehicle (A) | Number of Participants Having Local Skin Reactions With Improved/Same Versus Worsened Severities Compared to Baseline | Edema, Week 7 (Worsened) | 0 Participants |
| FMX101 Oil Vehicle (A) | Number of Participants Having Local Skin Reactions With Improved/Same Versus Worsened Severities Compared to Baseline | Erythema, Week 1 (Worsened) | 1 Participants |
| FMX101 Oil Vehicle (A) | Number of Participants Having Local Skin Reactions With Improved/Same Versus Worsened Severities Compared to Baseline | Scaling/Dryness, Week 1 (Improved/Same) | 10 Participants |
| FMX101 Oil Vehicle (A) | Number of Participants Having Local Skin Reactions With Improved/Same Versus Worsened Severities Compared to Baseline | Pruritus, Week 2 (Improved/Same) | 11 Participants |
| FMX101 Oil Vehicle (A) | Number of Participants Having Local Skin Reactions With Improved/Same Versus Worsened Severities Compared to Baseline | Scaling/Dryness, Week 1 (Worsened) | 0 Participants |
| FMX101 Oil Vehicle (A) | Number of Participants Having Local Skin Reactions With Improved/Same Versus Worsened Severities Compared to Baseline | Erythema, Week 2 (Improved/Same) | 11 Participants |
| FMX101 Oil Vehicle (A) | Number of Participants Having Local Skin Reactions With Improved/Same Versus Worsened Severities Compared to Baseline | Scaling/Dryness, Week 2 (Improved/Same) | 9 Participants |
| FMX101 Oil Vehicle (A) | Number of Participants Having Local Skin Reactions With Improved/Same Versus Worsened Severities Compared to Baseline | Pain, Week 4 (Worsened) | 0 Participants |
| FMX101 Oil Vehicle (A) | Number of Participants Having Local Skin Reactions With Improved/Same Versus Worsened Severities Compared to Baseline | Scaling/Dryness, Week 2 (Worsened) | 2 Participants |
| FMX101 Oil Vehicle (A) | Number of Participants Having Local Skin Reactions With Improved/Same Versus Worsened Severities Compared to Baseline | Erythema, Week 2 (Worsened) | 0 Participants |
| FMX101 Oil Vehicle (A) | Number of Participants Having Local Skin Reactions With Improved/Same Versus Worsened Severities Compared to Baseline | Scaling/Dryness, Week 4 (Improved/Same) | 9 Participants |
| FMX101 Oil Vehicle (A) | Number of Participants Having Local Skin Reactions With Improved/Same Versus Worsened Severities Compared to Baseline | Pruritus, Week 2 (Worsened) | 0 Participants |
| FMX101 Oil Vehicle (A) | Number of Participants Having Local Skin Reactions With Improved/Same Versus Worsened Severities Compared to Baseline | Scaling/Dryness, Week 4 (Worsened) | 0 Participants |
| FMX101 Oil Vehicle (A) | Number of Participants Having Local Skin Reactions With Improved/Same Versus Worsened Severities Compared to Baseline | Erythema, Week 4 (Improved/Same) | 9 Participants |
| FMX101 Oil Vehicle (A) | Number of Participants Having Local Skin Reactions With Improved/Same Versus Worsened Severities Compared to Baseline | Scaling/Dryness, Week 6 (Improved/Same) | 9 Participants |
| FMX101 Oil Vehicle (A) | Number of Participants Having Local Skin Reactions With Improved/Same Versus Worsened Severities Compared to Baseline | Pain, Week 7 (Improved/Same) | 11 Participants |
| FMX101 Oil Vehicle (A) | Number of Participants Having Local Skin Reactions With Improved/Same Versus Worsened Severities Compared to Baseline | Scaling/Dryness, Week 6 (Worsened) | 1 Participants |
| FMX101 Oil Vehicle (A) | Number of Participants Having Local Skin Reactions With Improved/Same Versus Worsened Severities Compared to Baseline | Erythema, Week 4 (Worsened) | 0 Participants |
| FMX101 Oil Vehicle (A) | Number of Participants Having Local Skin Reactions With Improved/Same Versus Worsened Severities Compared to Baseline | Scaling/Dryness, Week 7 (Improved/Same) | 10 Participants |
| FMX101 Oil Vehicle (A) | Number of Participants Having Local Skin Reactions With Improved/Same Versus Worsened Severities Compared to Baseline | Pruritus, Week 4 (Improved/Same) | 9 Participants |
| FMX101 Oil Vehicle (A) | Number of Participants Having Local Skin Reactions With Improved/Same Versus Worsened Severities Compared to Baseline | Scaling/Dryness, Week 7 (Worsened) | 1 Participants |
| FMX101 Oil Vehicle (A) | Number of Participants Having Local Skin Reactions With Improved/Same Versus Worsened Severities Compared to Baseline | Erythema, Week 6 (Improved/Same) | 10 Participants |
| FMX101 Oil Vehicle (A) | Number of Participants Having Local Skin Reactions With Improved/Same Versus Worsened Severities Compared to Baseline | Erosion, Week 1 (Improved/Same) | 10 Participants |
| FMX101 Oil Vehicle (A) | Number of Participants Having Local Skin Reactions With Improved/Same Versus Worsened Severities Compared to Baseline | Pain, Week 4 (Improved/Same) | 9 Participants |
| FMX101 Oil Vehicle (A) | Number of Participants Having Local Skin Reactions With Improved/Same Versus Worsened Severities Compared to Baseline | Erosion, Week 1 (Worsened) | 0 Participants |
| FMX101 Oil Vehicle (A) | Number of Participants Having Local Skin Reactions With Improved/Same Versus Worsened Severities Compared to Baseline | Erythema, Week 6 (Worsened) | 0 Participants |
| FMX101 Oil Vehicle (A) | Number of Participants Having Local Skin Reactions With Improved/Same Versus Worsened Severities Compared to Baseline | Erosion, Week 2 (Improved/Same) | 11 Participants |
| FMX101 Oil Vehicle (A) | Number of Participants Having Local Skin Reactions With Improved/Same Versus Worsened Severities Compared to Baseline | Pruritus, Week 4 (Worsened) | 0 Participants |
| FMX101 Oil Vehicle (A) | Number of Participants Having Local Skin Reactions With Improved/Same Versus Worsened Severities Compared to Baseline | Erosion, Week 2 (Worsened) | 0 Participants |
| FMX101 Oil Vehicle (A) | Number of Participants Having Local Skin Reactions With Improved/Same Versus Worsened Severities Compared to Baseline | Erythema, Week 7 (Improved/Same) | 11 Participants |
| FMX101 Oil Vehicle (A) | Number of Participants Having Local Skin Reactions With Improved/Same Versus Worsened Severities Compared to Baseline | Erosion, Week 4 (Improved/Same) | 9 Participants |
| FMX101 Oil Vehicle (A) | Number of Participants Having Local Skin Reactions With Improved/Same Versus Worsened Severities Compared to Baseline | Pain, Week 7 (Worsened) | 0 Participants |
| FMX101 Oil Vehicle (A) | Number of Participants Having Local Skin Reactions With Improved/Same Versus Worsened Severities Compared to Baseline | Erosion, Week 4 (Worsened) | 0 Participants |
| FMX101 Oil Vehicle (A) | Number of Participants Having Local Skin Reactions With Improved/Same Versus Worsened Severities Compared to Baseline | Erythema, Week 7 (Worsened) | 0 Participants |
| FMX101 Oil Vehicle (A) | Number of Participants Having Local Skin Reactions With Improved/Same Versus Worsened Severities Compared to Baseline | Erosion, Week 6 (Improved/Same) | 10 Participants |
| FMX101 Oil Vehicle (A) | Number of Participants Having Local Skin Reactions With Improved/Same Versus Worsened Severities Compared to Baseline | Pruritus, Week 6 (Improved/Same) | 10 Participants |
| FMX101 Oil Vehicle (A) | Number of Participants Having Local Skin Reactions With Improved/Same Versus Worsened Severities Compared to Baseline | Erosion, Week 6 (Worsened) | 0 Participants |
| FMX101 Oil Vehicle (A) | Number of Participants Having Local Skin Reactions With Improved/Same Versus Worsened Severities Compared to Baseline | Edema, Week 1 (Improved/Same) | 10 Participants |
| FMX101 Oil Vehicle (A) | Number of Participants Having Local Skin Reactions With Improved/Same Versus Worsened Severities Compared to Baseline | Burning/Stinging, Week 2 (Improved/Same) | 11 Participants |
| FMX101 Oil Vehicle (A) | Number of Participants Having Local Skin Reactions With Improved/Same Versus Worsened Severities Compared to Baseline | Pain, Week 6 (Improved/Same) | 10 Participants |
| FMX101 Oil Vehicle (A) | Number of Participants Having Local Skin Reactions With Improved/Same Versus Worsened Severities Compared to Baseline | Burning/Stinging, Week 2 (Worsened) | 0 Participants |
| FMX101 Oil Vehicle (A) | Number of Participants Having Local Skin Reactions With Improved/Same Versus Worsened Severities Compared to Baseline | Edema, Week 1 (Worsened) | 0 Participants |
| FMX101 Oil Vehicle (A) | Number of Participants Having Local Skin Reactions With Improved/Same Versus Worsened Severities Compared to Baseline | Burning/Stinging, Week 4 (Improved/Same) | 9 Participants |
| FMX101 Oil Vehicle (A) | Number of Participants Having Local Skin Reactions With Improved/Same Versus Worsened Severities Compared to Baseline | Pruritus, Week 6 (Worsened) | 0 Participants |
| FMX101 Oil Vehicle (A) | Number of Participants Having Local Skin Reactions With Improved/Same Versus Worsened Severities Compared to Baseline | Burning/Stinging, Week 4 (Worsened) | 0 Participants |
| FMX101 Oil Vehicle (A) | Number of Participants Having Local Skin Reactions With Improved/Same Versus Worsened Severities Compared to Baseline | Edema, Week 2 (Improved/Same) | 11 Participants |
| FMX101 Oil Vehicle (A) | Number of Participants Having Local Skin Reactions With Improved/Same Versus Worsened Severities Compared to Baseline | Burning/Stinging, Week 6 (Improved/Same) | 10 Participants |
| FMX101 Oil Vehicle (A) | Number of Participants Having Local Skin Reactions With Improved/Same Versus Worsened Severities Compared to Baseline | Pruritus, Week 1 (Improved/Same) | 10 Participants |
| FMX101 Oil Vehicle (A) | Number of Participants Having Local Skin Reactions With Improved/Same Versus Worsened Severities Compared to Baseline | Burning/Stinging, Week 6 (Worsened) | 0 Participants |
| FMX101 Oil Vehicle (A) | Number of Participants Having Local Skin Reactions With Improved/Same Versus Worsened Severities Compared to Baseline | Edema, Week 2 (Worsened) | 0 Participants |
| FMX101 Oil Vehicle (A) | Number of Participants Having Local Skin Reactions With Improved/Same Versus Worsened Severities Compared to Baseline | Burning/Stinging, Week 7 (Improved/Same) | 11 Participants |
| FMX101 Oil Vehicle (A) | Number of Participants Having Local Skin Reactions With Improved/Same Versus Worsened Severities Compared to Baseline | Pruritus, Week 7 (Improved/Same) | 11 Participants |
| FMX101 Oil Vehicle (A) | Number of Participants Having Local Skin Reactions With Improved/Same Versus Worsened Severities Compared to Baseline | Burning/Stinging, Week 7 (Worsened) | 0 Participants |
| FMX101 Oil Vehicle (A) | Number of Participants Having Local Skin Reactions With Improved/Same Versus Worsened Severities Compared to Baseline | Edema, Week 4 (Improved/Same) | 9 Participants |
| FMX101 Oil Vehicle (A) | Number of Participants Having Local Skin Reactions With Improved/Same Versus Worsened Severities Compared to Baseline | Pain, Week 1 (Improved/Same) | 10 Participants |
| FMX101 Oil Vehicle (A) | Number of Participants Having Local Skin Reactions With Improved/Same Versus Worsened Severities Compared to Baseline | Pain, Week 2 (Worsened) | 0 Participants |
| FMX101 Oil Vehicle (A) | Number of Participants Having Local Skin Reactions With Improved/Same Versus Worsened Severities Compared to Baseline | Erosion, Week 7 (Improved/Same) | 11 Participants |
| FMX101 Oil Vehicle (A) | Number of Participants Having Local Skin Reactions With Improved/Same Versus Worsened Severities Compared to Baseline | Edema, Week 4 (Worsened) | 0 Participants |
| FMX101 Oil Vehicle (A) | Number of Participants Having Local Skin Reactions With Improved/Same Versus Worsened Severities Compared to Baseline | Erosion, Week 7 (Worsened) | 0 Participants |
| FMX101 Oil Vehicle (A) | Number of Participants Having Local Skin Reactions With Improved/Same Versus Worsened Severities Compared to Baseline | Pruritus, Week 7 (Worsened) | 0 Participants |
| FMX101 Oil Vehicle (A) | Number of Participants Having Local Skin Reactions With Improved/Same Versus Worsened Severities Compared to Baseline | Burning/Stinging, Week 1 (Improved/Same) | 10 Participants |
| FMX101 Oil Vehicle (A) | Number of Participants Having Local Skin Reactions With Improved/Same Versus Worsened Severities Compared to Baseline | Edema, Week 6 (Improved/Same) | 10 Participants |
| FMX101 Oil Vehicle (A) | Number of Participants Having Local Skin Reactions With Improved/Same Versus Worsened Severities Compared to Baseline | Burning/Stinging, Week 1 (Worsened) | 0 Participants |
| FMX101 Oil Vehicle (A) | Number of Participants Having Local Skin Reactions With Improved/Same Versus Worsened Severities Compared to Baseline | Pruritus, Week 1 (Worsened) | 0 Participants |
| FMX101 Oil Vehicle (A) | Number of Participants Having Local Skin Reactions With Improved/Same Versus Worsened Severities Compared to Baseline | Pain, Week 1 (Worsened) | 0 Participants |
| FMX101 Oil Vehicle (A) | Number of Participants Having Local Skin Reactions With Improved/Same Versus Worsened Severities Compared to Baseline | Pain, Week 2 (Improved/Same) | 11 Participants |
| Hydro-alcohol Vehicle (B) | Number of Participants Having Local Skin Reactions With Improved/Same Versus Worsened Severities Compared to Baseline | Pain, Week 1 (Worsened) | 0 Participants |
| Hydro-alcohol Vehicle (B) | Number of Participants Having Local Skin Reactions With Improved/Same Versus Worsened Severities Compared to Baseline | Pain, Week 2 (Improved/Same) | 11 Participants |
| Hydro-alcohol Vehicle (B) | Number of Participants Having Local Skin Reactions With Improved/Same Versus Worsened Severities Compared to Baseline | Pain, Week 2 (Worsened) | 0 Participants |
| Hydro-alcohol Vehicle (B) | Number of Participants Having Local Skin Reactions With Improved/Same Versus Worsened Severities Compared to Baseline | Pain, Week 4 (Improved/Same) | 9 Participants |
| Hydro-alcohol Vehicle (B) | Number of Participants Having Local Skin Reactions With Improved/Same Versus Worsened Severities Compared to Baseline | Pain, Week 4 (Worsened) | 0 Participants |
| Hydro-alcohol Vehicle (B) | Number of Participants Having Local Skin Reactions With Improved/Same Versus Worsened Severities Compared to Baseline | Pain, Week 6 (Improved/Same) | 10 Participants |
| Hydro-alcohol Vehicle (B) | Number of Participants Having Local Skin Reactions With Improved/Same Versus Worsened Severities Compared to Baseline | Pain, Week 6 (Worsened) | 0 Participants |
| Hydro-alcohol Vehicle (B) | Number of Participants Having Local Skin Reactions With Improved/Same Versus Worsened Severities Compared to Baseline | Pain, Week 7 (Improved/Same) | 11 Participants |
| Hydro-alcohol Vehicle (B) | Number of Participants Having Local Skin Reactions With Improved/Same Versus Worsened Severities Compared to Baseline | Pain, Week 7 (Worsened) | 0 Participants |
| Hydro-alcohol Vehicle (B) | Number of Participants Having Local Skin Reactions With Improved/Same Versus Worsened Severities Compared to Baseline | Pruritus, Week 1 (Improved/Same) | 10 Participants |
| Hydro-alcohol Vehicle (B) | Number of Participants Having Local Skin Reactions With Improved/Same Versus Worsened Severities Compared to Baseline | Pruritus, Week 1 (Worsened) | 0 Participants |
| Hydro-alcohol Vehicle (B) | Number of Participants Having Local Skin Reactions With Improved/Same Versus Worsened Severities Compared to Baseline | Pruritus, Week 2 (Improved/Same) | 11 Participants |
| Hydro-alcohol Vehicle (B) | Number of Participants Having Local Skin Reactions With Improved/Same Versus Worsened Severities Compared to Baseline | Pruritus, Week 2 (Worsened) | 0 Participants |
| Hydro-alcohol Vehicle (B) | Number of Participants Having Local Skin Reactions With Improved/Same Versus Worsened Severities Compared to Baseline | Pruritus, Week 4 (Improved/Same) | 9 Participants |
| Hydro-alcohol Vehicle (B) | Number of Participants Having Local Skin Reactions With Improved/Same Versus Worsened Severities Compared to Baseline | Pruritus, Week 4 (Worsened) | 0 Participants |
| Hydro-alcohol Vehicle (B) | Number of Participants Having Local Skin Reactions With Improved/Same Versus Worsened Severities Compared to Baseline | Pruritus, Week 6 (Improved/Same) | 10 Participants |
| Hydro-alcohol Vehicle (B) | Number of Participants Having Local Skin Reactions With Improved/Same Versus Worsened Severities Compared to Baseline | Pruritus, Week 6 (Worsened) | 0 Participants |
| Hydro-alcohol Vehicle (B) | Number of Participants Having Local Skin Reactions With Improved/Same Versus Worsened Severities Compared to Baseline | Pruritus, Week 7 (Improved/Same) | 11 Participants |
| Hydro-alcohol Vehicle (B) | Number of Participants Having Local Skin Reactions With Improved/Same Versus Worsened Severities Compared to Baseline | Pruritus, Week 7 (Worsened) | 0 Participants |
| Hydro-alcohol Vehicle (B) | Number of Participants Having Local Skin Reactions With Improved/Same Versus Worsened Severities Compared to Baseline | Erythema, Week 1 (Improved/Same) | 9 Participants |
| Hydro-alcohol Vehicle (B) | Number of Participants Having Local Skin Reactions With Improved/Same Versus Worsened Severities Compared to Baseline | Erythema, Week 1 (Worsened) | 1 Participants |
| Hydro-alcohol Vehicle (B) | Number of Participants Having Local Skin Reactions With Improved/Same Versus Worsened Severities Compared to Baseline | Erythema, Week 2 (Improved/Same) | 11 Participants |
| Hydro-alcohol Vehicle (B) | Number of Participants Having Local Skin Reactions With Improved/Same Versus Worsened Severities Compared to Baseline | Erythema, Week 2 (Worsened) | 0 Participants |
| Hydro-alcohol Vehicle (B) | Number of Participants Having Local Skin Reactions With Improved/Same Versus Worsened Severities Compared to Baseline | Erythema, Week 4 (Improved/Same) | 9 Participants |
| Hydro-alcohol Vehicle (B) | Number of Participants Having Local Skin Reactions With Improved/Same Versus Worsened Severities Compared to Baseline | Erythema, Week 4 (Worsened) | 0 Participants |
| Hydro-alcohol Vehicle (B) | Number of Participants Having Local Skin Reactions With Improved/Same Versus Worsened Severities Compared to Baseline | Erythema, Week 6 (Improved/Same) | 10 Participants |
| Hydro-alcohol Vehicle (B) | Number of Participants Having Local Skin Reactions With Improved/Same Versus Worsened Severities Compared to Baseline | Erythema, Week 6 (Worsened) | 0 Participants |
| Hydro-alcohol Vehicle (B) | Number of Participants Having Local Skin Reactions With Improved/Same Versus Worsened Severities Compared to Baseline | Erythema, Week 7 (Improved/Same) | 11 Participants |
| Hydro-alcohol Vehicle (B) | Number of Participants Having Local Skin Reactions With Improved/Same Versus Worsened Severities Compared to Baseline | Erythema, Week 7 (Worsened) | 0 Participants |
| Hydro-alcohol Vehicle (B) | Number of Participants Having Local Skin Reactions With Improved/Same Versus Worsened Severities Compared to Baseline | Edema, Week 1 (Improved/Same) | 10 Participants |
| Hydro-alcohol Vehicle (B) | Number of Participants Having Local Skin Reactions With Improved/Same Versus Worsened Severities Compared to Baseline | Edema, Week 1 (Worsened) | 0 Participants |
| Hydro-alcohol Vehicle (B) | Number of Participants Having Local Skin Reactions With Improved/Same Versus Worsened Severities Compared to Baseline | Edema, Week 2 (Improved/Same) | 11 Participants |
| Hydro-alcohol Vehicle (B) | Number of Participants Having Local Skin Reactions With Improved/Same Versus Worsened Severities Compared to Baseline | Edema, Week 2 (Worsened) | 0 Participants |
| Hydro-alcohol Vehicle (B) | Number of Participants Having Local Skin Reactions With Improved/Same Versus Worsened Severities Compared to Baseline | Edema, Week 4 (Improved/Same) | 9 Participants |
| Hydro-alcohol Vehicle (B) | Number of Participants Having Local Skin Reactions With Improved/Same Versus Worsened Severities Compared to Baseline | Edema, Week 4 (Worsened) | 0 Participants |
| Hydro-alcohol Vehicle (B) | Number of Participants Having Local Skin Reactions With Improved/Same Versus Worsened Severities Compared to Baseline | Edema, Week 6 (Improved/Same) | 10 Participants |
| Hydro-alcohol Vehicle (B) | Number of Participants Having Local Skin Reactions With Improved/Same Versus Worsened Severities Compared to Baseline | Edema, Week 6 (Worsened) | 0 Participants |
| Hydro-alcohol Vehicle (B) | Number of Participants Having Local Skin Reactions With Improved/Same Versus Worsened Severities Compared to Baseline | Edema, Week 7 (Improved/Same) | 11 Participants |
| Hydro-alcohol Vehicle (B) | Number of Participants Having Local Skin Reactions With Improved/Same Versus Worsened Severities Compared to Baseline | Edema, Week 7 (Worsened) | 0 Participants |
| Hydro-alcohol Vehicle (B) | Number of Participants Having Local Skin Reactions With Improved/Same Versus Worsened Severities Compared to Baseline | Scaling/Dryness, Week 1 (Improved/Same) | 9 Participants |
| Hydro-alcohol Vehicle (B) | Number of Participants Having Local Skin Reactions With Improved/Same Versus Worsened Severities Compared to Baseline | Scaling/Dryness, Week 1 (Worsened) | 1 Participants |
| Hydro-alcohol Vehicle (B) | Number of Participants Having Local Skin Reactions With Improved/Same Versus Worsened Severities Compared to Baseline | Scaling/Dryness, Week 2 (Improved/Same) | 8 Participants |
| Hydro-alcohol Vehicle (B) | Number of Participants Having Local Skin Reactions With Improved/Same Versus Worsened Severities Compared to Baseline | Scaling/Dryness, Week 2 (Worsened) | 3 Participants |
| Hydro-alcohol Vehicle (B) | Number of Participants Having Local Skin Reactions With Improved/Same Versus Worsened Severities Compared to Baseline | Scaling/Dryness, Week 4 (Improved/Same) | 9 Participants |
| Hydro-alcohol Vehicle (B) | Number of Participants Having Local Skin Reactions With Improved/Same Versus Worsened Severities Compared to Baseline | Scaling/Dryness, Week 4 (Worsened) | 0 Participants |
| Hydro-alcohol Vehicle (B) | Number of Participants Having Local Skin Reactions With Improved/Same Versus Worsened Severities Compared to Baseline | Scaling/Dryness, Week 6 (Improved/Same) | 8 Participants |
| Hydro-alcohol Vehicle (B) | Number of Participants Having Local Skin Reactions With Improved/Same Versus Worsened Severities Compared to Baseline | Scaling/Dryness, Week 6 (Worsened) | 2 Participants |
| Hydro-alcohol Vehicle (B) | Number of Participants Having Local Skin Reactions With Improved/Same Versus Worsened Severities Compared to Baseline | Scaling/Dryness, Week 7 (Improved/Same) | 11 Participants |
| Hydro-alcohol Vehicle (B) | Number of Participants Having Local Skin Reactions With Improved/Same Versus Worsened Severities Compared to Baseline | Scaling/Dryness, Week 7 (Worsened) | 0 Participants |
| Hydro-alcohol Vehicle (B) | Number of Participants Having Local Skin Reactions With Improved/Same Versus Worsened Severities Compared to Baseline | Erosion, Week 1 (Improved/Same) | 10 Participants |
| Hydro-alcohol Vehicle (B) | Number of Participants Having Local Skin Reactions With Improved/Same Versus Worsened Severities Compared to Baseline | Erosion, Week 1 (Worsened) | 0 Participants |
| Hydro-alcohol Vehicle (B) | Number of Participants Having Local Skin Reactions With Improved/Same Versus Worsened Severities Compared to Baseline | Erosion, Week 2 (Improved/Same) | 11 Participants |
| Hydro-alcohol Vehicle (B) | Number of Participants Having Local Skin Reactions With Improved/Same Versus Worsened Severities Compared to Baseline | Erosion, Week 2 (Worsened) | 0 Participants |
| Hydro-alcohol Vehicle (B) | Number of Participants Having Local Skin Reactions With Improved/Same Versus Worsened Severities Compared to Baseline | Erosion, Week 4 (Improved/Same) | 9 Participants |
| Hydro-alcohol Vehicle (B) | Number of Participants Having Local Skin Reactions With Improved/Same Versus Worsened Severities Compared to Baseline | Erosion, Week 4 (Worsened) | 0 Participants |
| Hydro-alcohol Vehicle (B) | Number of Participants Having Local Skin Reactions With Improved/Same Versus Worsened Severities Compared to Baseline | Erosion, Week 6 (Improved/Same) | 10 Participants |
| Hydro-alcohol Vehicle (B) | Number of Participants Having Local Skin Reactions With Improved/Same Versus Worsened Severities Compared to Baseline | Burning/Stinging, Week 1 (Worsened) | 0 Participants |
| Hydro-alcohol Vehicle (B) | Number of Participants Having Local Skin Reactions With Improved/Same Versus Worsened Severities Compared to Baseline | Burning/Stinging, Week 2 (Improved/Same) | 10 Participants |
| Hydro-alcohol Vehicle (B) | Number of Participants Having Local Skin Reactions With Improved/Same Versus Worsened Severities Compared to Baseline | Burning/Stinging, Week 2 (Worsened) | 1 Participants |
| Hydro-alcohol Vehicle (B) | Number of Participants Having Local Skin Reactions With Improved/Same Versus Worsened Severities Compared to Baseline | Burning/Stinging, Week 4 (Improved/Same) | 9 Participants |
| Hydro-alcohol Vehicle (B) | Number of Participants Having Local Skin Reactions With Improved/Same Versus Worsened Severities Compared to Baseline | Burning/Stinging, Week 4 (Worsened) | 0 Participants |
| Hydro-alcohol Vehicle (B) | Number of Participants Having Local Skin Reactions With Improved/Same Versus Worsened Severities Compared to Baseline | Burning/Stinging, Week 6 (Improved/Same) | 10 Participants |
| Hydro-alcohol Vehicle (B) | Number of Participants Having Local Skin Reactions With Improved/Same Versus Worsened Severities Compared to Baseline | Burning/Stinging, Week 6 (Worsened) | 0 Participants |
| Hydro-alcohol Vehicle (B) | Number of Participants Having Local Skin Reactions With Improved/Same Versus Worsened Severities Compared to Baseline | Burning/Stinging, Week 7 (Improved/Same) | 11 Participants |
| Hydro-alcohol Vehicle (B) | Number of Participants Having Local Skin Reactions With Improved/Same Versus Worsened Severities Compared to Baseline | Burning/Stinging, Week 7 (Worsened) | 0 Participants |
| Hydro-alcohol Vehicle (B) | Number of Participants Having Local Skin Reactions With Improved/Same Versus Worsened Severities Compared to Baseline | Erosion, Week 6 (Worsened) | 0 Participants |
| Hydro-alcohol Vehicle (B) | Number of Participants Having Local Skin Reactions With Improved/Same Versus Worsened Severities Compared to Baseline | Erosion, Week 7 (Improved/Same) | 11 Participants |
| Hydro-alcohol Vehicle (B) | Number of Participants Having Local Skin Reactions With Improved/Same Versus Worsened Severities Compared to Baseline | Erosion, Week 7 (Worsened) | 0 Participants |
| Hydro-alcohol Vehicle (B) | Number of Participants Having Local Skin Reactions With Improved/Same Versus Worsened Severities Compared to Baseline | Burning/Stinging, Week 1 (Improved/Same) | 10 Participants |
| Hydro-alcohol Vehicle (B) | Number of Participants Having Local Skin Reactions With Improved/Same Versus Worsened Severities Compared to Baseline | Pain, Week 1 (Improved/Same) | 10 Participants |
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.
Time frame: At Week 6
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| FMX101 Oil Vehicle (A) | Number of Participants With 0 to 4 Investigator's Global Assessment Score at Week 6 | 1-Almost Clear | 3 Participants |
| FMX101 Oil Vehicle (A) | Number of Participants With 0 to 4 Investigator's Global Assessment Score at Week 6 | 3-Moderate | 3 Participants |
| FMX101 Oil Vehicle (A) | Number of Participants With 0 to 4 Investigator's Global Assessment Score at Week 6 | 2-Mild | 5 Participants |
| FMX101 Oil Vehicle (A) | Number of Participants With 0 to 4 Investigator's Global Assessment Score at Week 6 | 4-Severe | 0 Participants |
| FMX101 Oil Vehicle (A) | Number of Participants With 0 to 4 Investigator's Global Assessment Score at Week 6 | 0-Clear | 0 Participants |
| Hydro-alcohol Vehicle (B) | Number of Participants With 0 to 4 Investigator's Global Assessment Score at Week 6 | 4-Severe | 0 Participants |
| Hydro-alcohol Vehicle (B) | Number of Participants With 0 to 4 Investigator's Global Assessment Score at Week 6 | 0-Clear | 0 Participants |
| Hydro-alcohol Vehicle (B) | Number of Participants With 0 to 4 Investigator's Global Assessment Score at Week 6 | 1-Almost Clear | 3 Participants |
| Hydro-alcohol Vehicle (B) | Number of Participants With 0 to 4 Investigator's Global Assessment Score at Week 6 | 2-Mild | 3 Participants |
| Hydro-alcohol Vehicle (B) | Number of Participants With 0 to 4 Investigator's Global Assessment Score at Week 6 | 3-Moderate | 5 Participants |
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.
Time frame: Day 1 until Week 7 (End of Study) and Unscheduled Visit
Population: Safety population included all randomized participants who received test article and applied at least one application.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| FMX101 Oil Vehicle (A) | Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) | Any TEAEs | 5 Participants |
| FMX101 Oil Vehicle (A) | Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) | Any Treatment Related TEAEs | 0 Participants |
| FMX101 Oil Vehicle (A) | Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) | TEAEs Within the Treatment Area | 0 Participants |
| FMX101 Oil Vehicle (A) | Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) | Serious TEAEs | 0 Participants |
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).
Time frame: Day 1/ Baseline and Week 6
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| FMX101 Oil Vehicle (A) | Percentage Change From Baseline to Week 6 in Inflammatory Lesion Count | -37.7 Percent Change | Standard Deviation 42.88 |
| Hydro-alcohol Vehicle (B) | Percentage Change From Baseline to Week 6 in Inflammatory Lesion Count | -39.0 Percent Change | Standard Deviation 30.83 |
Primary
Percentage Change From Baseline to Week 6 in Non-Inflammatory Lesion Count
The NILC included open and closed comedones.
Time frame: Day 1/ Baseline and Week 6
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| FMX101 Oil Vehicle (A) | Percentage Change From Baseline to Week 6 in Non-Inflammatory Lesion Count | -33.2 Percent Change | Standard Deviation 24.65 |
| Hydro-alcohol Vehicle (B) | Percentage Change From Baseline to Week 6 in Non-Inflammatory Lesion Count | -24.0 Percent Change | Standard Deviation 24.15 |