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Participant Reported Outcomes with use of Trifarotene 50 μg/g Cream in participants with Moderate Facial and Truncal Acne Vulgaris
There was no formal hypothesis to be tested. Approximately 50 subjects would be enrolled to evaluate the subject reported outcomes (quality of life and satisfaction survey). The sample size was not based on any formal hypothesis testing.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Trifarotene | Experimental | Participants applied Trifarotene 50 μg/g topically once daily in the evening for 24 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Trifarotene | Drug | Topical Cream |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at Week 12 and 24 | The DLQI was validated 10-item questionnaire for participants aged >16 years that measured the dermatology-related limitations of functional ability and the frequency, severity, and impact of general inflammatory skin conditions on the quality-of-life (QOL). The total DLQI score was calculated by summing the scores of each question, resulting in a maximum of 30 and a minimum of 0. Responses to each questions were assessed on a scale of 0 to 3, where 0 is "not at all" and 3 is "very much". Scores from all 10 questions added up to give total DLQI scores ranged from 0 (not at all) to 30 (very much), higher scores indicated more impact on quality of life. | Baseline, Week 12 and Week 24 |
| Change From Baseline in C-DLQI (Children's Dermatology Life Quality Index) Score at Week 12 and 24 | The C-DLQI are validated 10-item questionnaire for participants aged <=16 that measured the dermatology related limitations of functional ability and the frequency, severity, and impact of general inflammatory skin conditions on the quality-of-life (QOL). Questions were scored as follows: No effect (0-1), Small effect (2-6), Moderate effect (7-12), Very large effect (13-18), Extremely large effect (19-30). The total C-DLQI score was calculated by summing the scores of each question, resulting in a maximum of 30 (Extremely large effect) and a minimum of 0 (No effect). A lower score on the C-DLQI indicates increased QOL. | Baseline, Week 12 and Week 24 |
| Change From Baseline in Comprehensive Quality of Life (QOL) Measure for Facial and Truncal Acne (CompAQ) Total Score at Week 12, 24 | The CompAQ questionnaire is a comprehensive measure of facial and truncal acne's impact on health-related QOL. The 20 questions consisted of 5 domains that assessed a variety of psychosocial and physical impacts of acne: Psychological/Emotional, Social (Judgement from Others), Social Interactions, Treatment Concerns, Physical Symptoms. Each question is assessed with a numeric score between 0 (Never) and 8 (All the time) with a total possible score range of 0 (No effect) -160 (greater adverse impact). The higher the score, the more quality of life is impaired. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Achieved an IGA Score of 1 (Almost Clear) or 0 (Clear) and At Least a 2-Grade Improvement From Baseline to Week 12 and Week 24 | IGA was an assessment scale used to evaluate facial acne severity. IGA was recorded from components collected on the case report form (CRF) using a 5-point scale where (0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe) based on inflammation, pustules and papulation/infiltration. Success Rate was defined as the percentage of participants who achieved an IGA score of 1 (Almost Clear) or 0 (Clear) and at least a 2-grade improvement from Baseline to Week 12 and Week 24. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Galderma Investigational Site | Fort Smith | Arkansas | 72916 | United States | ||
| Galderma Investigational Site |
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A total of 47 participants were enrolled in the study. Of which, 46 participants were treated.
The study was conducted at United States between 27 March 2019 and 23 December 2019.
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| ID | Title | Description |
|---|---|---|
| FG000 | Trifarotene | Participants applied Trifarotene 50 μg/g topically once daily in the evening for 24 weeks. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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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 | Jun 4, 2019 | Oct 31, 2021 |
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| Baseline, Week 12 and Week 24 |
| Number of Participants With Satisfaction Questionnaire - Treatment Area Face at Week 12 and 24/End of Treatment (ET) | Participants Satisfaction Questionnaire included questions: a) How bothered were you by treatment side effects? : Not bothered at all, Bothered somewhat, Bothered, Bothered a great deal b) Satisfied with the time it took for treatment to work: Very satisfied, Satisfied, Somewhat satisfied, Not satisfied c) How satisfied were you with the effectiveness of the treatment? Very satisfied, Satisfied, Somewhat satisfied, Not satisfied d) How do you feel about yourself, since starting your treatment?: Very much better, A lot better, A little better, Worse. e) Overall, are you satisfied with the treatment? : Very satisfied, Satisfied, Somewhat satisfied, Not satisfied. f) Would you consider using this treatment again: Yes, No. g) Did you use the provided moisturizing lotion?: Yes, No. | Week 12 and Week 24/End of Treatment (ET) |
| Number of Participants With Satisfaction Questionnaire - Treatment Area Trunk at Week 12 and 24/ End of Treatment (ET) | Participants Satisfaction Questionnaire included questions: a) How bothered were you by treatment side effects? : Not bothered at all, Bothered somewhat, Bothered, Bothered a great deal b) Satisfied with the time it took for treatment to work: Very satisfied, Satisfied, Somewhat satisfied, Not satisfied c) How satisfied were you with the effectiveness of the treatment? Very satisfied, Satisfied, Somewhat satisfied, Not satisfied d) How do you feel about yourself, since starting your treatment?: Very much better, A lot better, A little better, Worse. e) Overall, are you satisfied with the treatment? : Very satisfied, Satisfied, Somewhat satisfied, Not satisfied. f) Would you consider using this treatment again: Yes, No. g) Did you use the provided moisturizing lotion?: Yes, No. | Week 12 and Week 24/ET |
| Change From Baseline in EQ-5D-5L Index Score at Week 12 and 24 | EQ-5D-5L is a 2-part measurement. The first part is comprised of the following 5 participant-reported dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The responses are used to derive the health state index scores using the United States (US) algorithm, with scores ranging from -0.109 (extreme problems) to 1 (no problems). A higher score indicates better health state. | Baseline, Week 12 and Week 24 |
| Change From Baseline in EQ-5D-5L VAS at Week 12 and 24 | The EQ-5D-5L assesses general health-related quality of life. The second portion of the scale is a self-perceived health score assessed using a VAS that ranges from 0 (the worst imaginable health) to 100 (the best imaginable health), with higher scores indicating higher health utility. | Baseline, Week 12 and Week 24 |
| Baseline, Week 12 and Week 24 |
| Percentage of Participants With Physician's Global Assessment of Truncal Acne Success Rate at Week 12 and 24 | The Physician's Global Assessment (PGA) was an instrument to evaluate the truncal acne severity in the shoulders, upper back and upper anterior chest areas. PGA was recorded from components collected on the CRF using a 5-point scale where (0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe) based on inflammation, pustules and papulation/infiltration. Success Rate was defined as the percentage of participants who achieved an PGA score of 1 (Almost Clear) or 0 (Clear) and at least a 2-grade improvement from Baseline to Week 12 and Week 24. All missing values were imputed by LOCF. | Week 12 and 24 |
| Percent Change From Baseline in Facial Inflammatory and Non-inflammatory Lesion Count at Week 12 and 24 | Percent change from Baseline was calculated as the values at Week 12 (and 24) minus the value at Baseline divided by Baseline value * 100. All missing values were imputed by LOCF. | Baseline, Week 12 and 24 |
| Percent Change From Baseline in Trunk Inflammatory and Non-inflammatory Lesion Count at Week 12 and 24 | Percent change from Baseline was calculated as the values at Week 12 (and 24) minus the value at Baseline divided by Baseline value * 100. All missing values were imputed by LOCF. | Baseline, Week 12 and Week 24 |
| Beverly |
| Massachusetts |
| 01915 |
| United States |
| Galderma Investigational Site | Portsmouth | New Hampshire | 03801 | United States |
| Galderma Investigational Site | Philadelphia | Pennsylvania | 19103 | United States |
| Galderma Investigational Site | Austin | Texas | 78759 | United States |
| Galderma Investigational Site | Beaumont | Texas | 77701 | United States |
| Galderma Investigational Site | Irving | Texas | 75062 | United States |
| Galderma Investigational Site | Pflugerville | Texas | 78660 | United States |
| Galderma Investigational Site | Richardson | Texas | 75081 | United States |
| Treated |
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| COMPLETED |
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| NOT COMPLETED |
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Analysis was performed on Intent to treat (ITT) population that included all enrolled participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | Trifarotene | Participants applied Trifarotene 50 μg/g topically once daily in the evening for 24 weeks. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Dermatology Life Quality Index (DLQI) Score at Baseline | The DLQI was validated 10-item questionnaire that measured the dermatology-related limitations of functional ability and the frequency, severity, and impact of general inflammatory skin conditions on the quality-of-life (QOL). Total DLQI score was calculated by summing the scores of each question, resulting in a maximum of 30 and minimum of 0. Responses to each questions were assessed on a scale of 0 to 3, where 0="not at all" & 3="very much". Scores from all 10 questions added up to give total DLQI scores ranged from 0(not at all) to 30(very much),higher scores=more impact on quality of life | Here, number analyzed=participants with available data at Baseline. | Mean | Standard Deviation | score on a scale |
| |||||||||||||||
| C-DLQI (Children's Dermatology Life Quality Index) Score at Baseline | The C-DLQI are validated 10-item questionnaire that measured the dermatology related limitations of functional ability and the frequency, severity, and impact of general inflammatory skin conditions on the quality-of-life (QOL). Questions were scored as follows: No effect (0-1), Small effect (2-6), Moderate effect (7-12), Very large effect (13-18), Extremely large effect (19-30). The total C-DLQI score was calculated by summing the scores of each question, resulting in a maximum of 30 (Extremely large effect) and a minimum of 0 (No effect). A lower score on the C-DLQI indicates increased QOL. | Here, number analyzed=participants with available data at Baseline. | Mean | Standard Deviation | score on a scale |
| |||||||||||||||
| Comprehensive Quality of Life (QOL) Measure for Facial and Truncal Acne at Baseline | The CompAQ questionnaire is a comprehensive measure of facial and truncal acne's impact on health-related QOL. The 20 questions consisted of 5 domains that assessed a variety of psychosocial and physical impacts of acne: Psychological/Emotional, Social (Judgement from Others), Social Interactions, Treatment Concerns, Physical Symptoms. Each question is assessed with a numeric score between 0 (Never) and 8 (All the time) with a total possible score range of 0 (No effect) -160 (greater adverse impact). The higher the score, the more quality of life is impaired. | Here, number analyzed=participants with available data at Baseline | Mean | Standard Deviation | score on a scale |
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| EuroQoL 5-Dimension (EQ-5D-5L) Index Score at Baseline | EQ-5D-5L is a 2-part measurement. The first part is comprised of the following 5 participant-reported dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The responses are used to derive the health state index scores using the United States (US) algorithm, with scores ranging from -0.109 (extreme problems) to 1 (no problems). A higher score indicates better health state. | Mean | Standard Deviation | score on a scale |
| ||||||||||||||||
| EuroQoL 5-Dimension (EQ-5D-5L) VAS Score at Baseline | The EQ-5D-5L assesses general health-related quality of life. The second portion of the scale is a self-perceived health score assessed using a VAS that ranges from 0 (the worst imaginable health) to 100 (the best imaginable health), with higher scores indicating higher health utility. | Mean | Standard Deviation | score on a scale |
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| 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 | Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at Week 12 and 24 | The DLQI was validated 10-item questionnaire for participants aged >16 years that measured the dermatology-related limitations of functional ability and the frequency, severity, and impact of general inflammatory skin conditions on the quality-of-life (QOL). The total DLQI score was calculated by summing the scores of each question, resulting in a maximum of 30 and a minimum of 0. Responses to each questions were assessed on a scale of 0 to 3, where 0 is "not at all" and 3 is "very much". Scores from all 10 questions added up to give total DLQI scores ranged from 0 (not at all) to 30 (very much), higher scores indicated more impact on quality of life. | Analysis was performed on ITT population that included all enrolled participants. Here, overall number of participants analyzed=participants with available data at Week 12 and 24. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Week 12 and Week 24 |
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| Primary | Change From Baseline in C-DLQI (Children's Dermatology Life Quality Index) Score at Week 12 and 24 | The C-DLQI are validated 10-item questionnaire for participants aged <=16 that measured the dermatology related limitations of functional ability and the frequency, severity, and impact of general inflammatory skin conditions on the quality-of-life (QOL). Questions were scored as follows: No effect (0-1), Small effect (2-6), Moderate effect (7-12), Very large effect (13-18), Extremely large effect (19-30). The total C-DLQI score was calculated by summing the scores of each question, resulting in a maximum of 30 (Extremely large effect) and a minimum of 0 (No effect). A lower score on the C-DLQI indicates increased QOL. | Analysis was performed on ITT population. Here, overall number of participants analyzed=participants with available data at Baseline. Number analyzed=participants with available data at specified time-points. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Week 12 and Week 24 |
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| Primary | Change From Baseline in Comprehensive Quality of Life (QOL) Measure for Facial and Truncal Acne (CompAQ) Total Score at Week 12, 24 | The CompAQ questionnaire is a comprehensive measure of facial and truncal acne's impact on health-related QOL. The 20 questions consisted of 5 domains that assessed a variety of psychosocial and physical impacts of acne: Psychological/Emotional, Social (Judgement from Others), Social Interactions, Treatment Concerns, Physical Symptoms. Each question is assessed with a numeric score between 0 (Never) and 8 (All the time) with a total possible score range of 0 (No effect) -160 (greater adverse impact). The higher the score, the more quality of life is impaired. | Analysis was performed on ITT population. Here, overall number of participants analyzed=participants with available data at Baseline. Number analyzed=participants with available data at specified time-points. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Week 12 and Week 24 |
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| Primary | Number of Participants With Satisfaction Questionnaire - Treatment Area Face at Week 12 and 24/End of Treatment (ET) | Participants Satisfaction Questionnaire included questions: a) How bothered were you by treatment side effects? : Not bothered at all, Bothered somewhat, Bothered, Bothered a great deal b) Satisfied with the time it took for treatment to work: Very satisfied, Satisfied, Somewhat satisfied, Not satisfied c) How satisfied were you with the effectiveness of the treatment? Very satisfied, Satisfied, Somewhat satisfied, Not satisfied d) How do you feel about yourself, since starting your treatment?: Very much better, A lot better, A little better, Worse. e) Overall, are you satisfied with the treatment? : Very satisfied, Satisfied, Somewhat satisfied, Not satisfied. f) Would you consider using this treatment again: Yes, No. g) Did you use the provided moisturizing lotion?: Yes, No. | Analysis was performed on ITT population. Here, "number analyzed"=participants with available data at specified time-points. | Posted | Count of Participants | Participants | Week 12 and Week 24/End of Treatment (ET) |
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| Primary | Number of Participants With Satisfaction Questionnaire - Treatment Area Trunk at Week 12 and 24/ End of Treatment (ET) | Participants Satisfaction Questionnaire included questions: a) How bothered were you by treatment side effects? : Not bothered at all, Bothered somewhat, Bothered, Bothered a great deal b) Satisfied with the time it took for treatment to work: Very satisfied, Satisfied, Somewhat satisfied, Not satisfied c) How satisfied were you with the effectiveness of the treatment? Very satisfied, Satisfied, Somewhat satisfied, Not satisfied d) How do you feel about yourself, since starting your treatment?: Very much better, A lot better, A little better, Worse. e) Overall, are you satisfied with the treatment? : Very satisfied, Satisfied, Somewhat satisfied, Not satisfied. f) Would you consider using this treatment again: Yes, No. g) Did you use the provided moisturizing lotion?: Yes, No. | Analysis was performed on ITT population. Here, "number analyzed"=participants with available data at specified time-points. | Posted | Count of Participants | Participants | Week 12 and Week 24/ET |
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| Primary | Change From Baseline in EQ-5D-5L Index Score at Week 12 and 24 | EQ-5D-5L is a 2-part measurement. The first part is comprised of the following 5 participant-reported dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The responses are used to derive the health state index scores using the United States (US) algorithm, with scores ranging from -0.109 (extreme problems) to 1 (no problems). A higher score indicates better health state. | Analysis was performed on ITT population. Here, number analyzed=participants with available data at specified time-points. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Week 12 and Week 24 |
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| Primary | Change From Baseline in EQ-5D-5L VAS at Week 12 and 24 | The EQ-5D-5L assesses general health-related quality of life. The second portion of the scale is a self-perceived health score assessed using a VAS that ranges from 0 (the worst imaginable health) to 100 (the best imaginable health), with higher scores indicating higher health utility. | Analysis was performed on ITT population. Here, number analyzed=participants with available data at specified time-points. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Week 12 and Week 24 |
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| Secondary | Percentage of Participants Who Achieved an IGA Score of 1 (Almost Clear) or 0 (Clear) and At Least a 2-Grade Improvement From Baseline to Week 12 and Week 24 | IGA was an assessment scale used to evaluate facial acne severity. IGA was recorded from components collected on the case report form (CRF) using a 5-point scale where (0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe) based on inflammation, pustules and papulation/infiltration. Success Rate was defined as the percentage of participants who achieved an IGA score of 1 (Almost Clear) or 0 (Clear) and at least a 2-grade improvement from Baseline to Week 12 and Week 24. | Analysis was performed on Intent-to-treat (ITT) population that included all enrolled participants. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline, Week 12 and Week 24 |
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| Secondary | Percentage of Participants With Physician's Global Assessment of Truncal Acne Success Rate at Week 12 and 24 | The Physician's Global Assessment (PGA) was an instrument to evaluate the truncal acne severity in the shoulders, upper back and upper anterior chest areas. PGA was recorded from components collected on the CRF using a 5-point scale where (0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe) based on inflammation, pustules and papulation/infiltration. Success Rate was defined as the percentage of participants who achieved an PGA score of 1 (Almost Clear) or 0 (Clear) and at least a 2-grade improvement from Baseline to Week 12 and Week 24. All missing values were imputed by LOCF. | Analysis was performed on Intent-to-treat on the Trunk (ITTT) population that included any participants who were enrolled with moderate truncal acne at the Baseline visit. | Posted | Number | 95% Confidence Interval | percentage of participants | Week 12 and 24 |
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| Secondary | Percent Change From Baseline in Facial Inflammatory and Non-inflammatory Lesion Count at Week 12 and 24 | Percent change from Baseline was calculated as the values at Week 12 (and 24) minus the value at Baseline divided by Baseline value * 100. All missing values were imputed by LOCF. | Analysis was performed on ITT population. | Posted | Mean | Standard Deviation | percent change | Baseline, Week 12 and 24 |
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| Secondary | Percent Change From Baseline in Trunk Inflammatory and Non-inflammatory Lesion Count at Week 12 and 24 | Percent change from Baseline was calculated as the values at Week 12 (and 24) minus the value at Baseline divided by Baseline value * 100. All missing values were imputed by LOCF. | Analysis was performed on ITT population. | Posted | Mean | Standard Deviation | percent change | Baseline, Week 12 and Week 24 |
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From start of the study drug administration up to end of the study (Week 24).
Analysis was performed on Safety Population that included any enrolled participants who applied/were administered the study drug at least once.
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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 | Trifarotene | Participants applied Trifarotene 50 μg/g topically once daily in the evening for 24 weeks. | 0 | 46 | 0 | 46 | 9 | 46 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Application site pain | General disorders | MedDRA version 21.1. | Non-systematic Assessment |
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| Application site dermatitis | General disorders | MedDRA version 21.1. | Non-systematic Assessment |
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| Sunburn | Injury, poisoning and procedural complications | MedDRA version 21.1. | Non-systematic Assessment |
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Small sample size (no formal sample size calculation).
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Operations | Galderma | 817 961 5000 | 1 | Clinical.Studies@galderma.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 4, 2019 | Oct 31, 2021 | SAP_001.pdf |
| 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 |
|---|---|
| C000629420 | trifarotene |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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