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The Effects of Once-Daily Tretinoin 0.05% Lotion on Quality of Life in Patients with Moderate-to-Severe Acne Vulgaris
Background In two phase III clinical trials of patients with moderate-to-severe acne (NCT02932306, NCT02965456), tretinoin 0.05% lotion reduced inflammatory and noninflammatory lesions relative to vehicle lotion, with low potential for cutaneous irritation. Objective Data from these studies were ana...
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| Published in: | American journal of clinical dermatology 2020-12, Vol.21 (6), p.891-899 |
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| container_end_page | 899 |
| container_issue | 6 |
| container_start_page | 891 |
| container_title | American journal of clinical dermatology |
| container_volume | 21 |
| creator | Tyring, Stephen K. Kircik, Leon Pariser, David M. Woolery-Lloyd, Heather C. Harper, Julie C. Bhatt, Varsha Pillai, Radhakrishnan Guenin, Eric |
| description | Background
In two phase III clinical trials of patients with moderate-to-severe acne (NCT02932306, NCT02965456), tretinoin 0.05% lotion reduced inflammatory and noninflammatory lesions relative to vehicle lotion, with low potential for cutaneous irritation.
Objective
Data from these studies were analyzed post hoc to investigate the effects of tretinoin 0.05% lotion on patient-reported quality of life, as assessed using the Acne-Specific Quality of Life Questionnaire (Acne-QoL).
Methods
Mean changes from baseline to week 12 in Acne-QoL scores were analyzed in the pooled intent-to-treat population and a subgroup with treatment success (≥ 2-grade improvement on the Evaluator’s Global Severity Scale and rating of “clear” or “almost clear”). Pearson correlations were conducted in the pooled intent-to-treat population to assess the relationship between the Acne-QoL acne symptoms domain and each of the other three domains.
Results
In the pooled intent-to-treat population (
n
= 1640), greater mean improvements were found with tretinoin 0.05% lotion vs vehicle in all four domains: self-perception (mean change: 7.4 vs 6.7); role-emotional (6.8 vs 6.0); role-social (4.8 vs 4.6); acne symptoms (6.5 vs 5.6); all
p |
| doi_str_mv | 10.1007/s40257-020-00559-3 |
| format | article |
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In two phase III clinical trials of patients with moderate-to-severe acne (NCT02932306, NCT02965456), tretinoin 0.05% lotion reduced inflammatory and noninflammatory lesions relative to vehicle lotion, with low potential for cutaneous irritation.
Objective
Data from these studies were analyzed post hoc to investigate the effects of tretinoin 0.05% lotion on patient-reported quality of life, as assessed using the Acne-Specific Quality of Life Questionnaire (Acne-QoL).
Methods
Mean changes from baseline to week 12 in Acne-QoL scores were analyzed in the pooled intent-to-treat population and a subgroup with treatment success (≥ 2-grade improvement on the Evaluator’s Global Severity Scale and rating of “clear” or “almost clear”). Pearson correlations were conducted in the pooled intent-to-treat population to assess the relationship between the Acne-QoL acne symptoms domain and each of the other three domains.
Results
In the pooled intent-to-treat population (
n
= 1640), greater mean improvements were found with tretinoin 0.05% lotion vs vehicle in all four domains: self-perception (mean change: 7.4 vs 6.7); role-emotional (6.8 vs 6.0); role-social (4.8 vs 4.6); acne symptoms (6.5 vs 5.6); all
p
< 0.05. Relative to the intent-to-treat population, participants who experienced treatment success with tretinoin 0.05% lotion had higher (better) mean Acne-QoL scores at week 12. Correlations between acne symptoms and the other three domains were found at baseline and week 12 (
p
< 0.05).
Conclusions
Participants with moderate-to-severe acne reported better quality of life after 12 weeks of treatment with tretinoin 0.05% lotion. Clinical improvements in acne symptoms may have contributed to these outcomes.
Trial Registration
ClinicalTrials.gov: NCT02932306, NCT02965456.</description><identifier>ISSN: 1175-0561</identifier><identifier>EISSN: 1179-1888</identifier><identifier>DOI: 10.1007/s40257-020-00559-3</identifier><language>eng</language><publisher>Cham: Springer International Publishing</publisher><subject>Acne ; Clinical trials ; Dermatology ; Medicine ; Medicine & Public Health ; Original Research Article ; Pharmacology/Toxicology ; Pharmacotherapy ; Population ; Quality of life ; Questionnaires ; Self image ; Standard deviation ; Success</subject><ispartof>American journal of clinical dermatology, 2020-12, Vol.21 (6), p.891-899</ispartof><rights>Springer Nature Switzerland AG 2020</rights><rights>Copyright Springer Nature B.V. Dec 2020</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><cites>FETCH-LOGICAL-c303t-47ecd263e34b7c7652e634d0ef1113512420b0088a9b12a9e7a1e3b5dc3828353</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,780,784,27924,27925</link.rule.ids></links><search><creatorcontrib>Tyring, Stephen K.</creatorcontrib><creatorcontrib>Kircik, Leon</creatorcontrib><creatorcontrib>Pariser, David M.</creatorcontrib><creatorcontrib>Woolery-Lloyd, Heather C.</creatorcontrib><creatorcontrib>Harper, Julie C.</creatorcontrib><creatorcontrib>Bhatt, Varsha</creatorcontrib><creatorcontrib>Pillai, Radhakrishnan</creatorcontrib><creatorcontrib>Guenin, Eric</creatorcontrib><title>The Effects of Once-Daily Tretinoin 0.05% Lotion on Quality of Life in Patients with Moderate-to-Severe Acne Vulgaris</title><title>American journal of clinical dermatology</title><addtitle>Am J Clin Dermatol</addtitle><description>Background
In two phase III clinical trials of patients with moderate-to-severe acne (NCT02932306, NCT02965456), tretinoin 0.05% lotion reduced inflammatory and noninflammatory lesions relative to vehicle lotion, with low potential for cutaneous irritation.
Objective
Data from these studies were analyzed post hoc to investigate the effects of tretinoin 0.05% lotion on patient-reported quality of life, as assessed using the Acne-Specific Quality of Life Questionnaire (Acne-QoL).
Methods
Mean changes from baseline to week 12 in Acne-QoL scores were analyzed in the pooled intent-to-treat population and a subgroup with treatment success (≥ 2-grade improvement on the Evaluator’s Global Severity Scale and rating of “clear” or “almost clear”). Pearson correlations were conducted in the pooled intent-to-treat population to assess the relationship between the Acne-QoL acne symptoms domain and each of the other three domains.
Results
In the pooled intent-to-treat population (
n
= 1640), greater mean improvements were found with tretinoin 0.05% lotion vs vehicle in all four domains: self-perception (mean change: 7.4 vs 6.7); role-emotional (6.8 vs 6.0); role-social (4.8 vs 4.6); acne symptoms (6.5 vs 5.6); all
p
< 0.05. Relative to the intent-to-treat population, participants who experienced treatment success with tretinoin 0.05% lotion had higher (better) mean Acne-QoL scores at week 12. Correlations between acne symptoms and the other three domains were found at baseline and week 12 (
p
< 0.05).
Conclusions
Participants with moderate-to-severe acne reported better quality of life after 12 weeks of treatment with tretinoin 0.05% lotion. Clinical improvements in acne symptoms may have contributed to these outcomes.
Trial Registration
ClinicalTrials.gov: NCT02932306, NCT02965456.</description><subject>Acne</subject><subject>Clinical trials</subject><subject>Dermatology</subject><subject>Medicine</subject><subject>Medicine & Public Health</subject><subject>Original Research Article</subject><subject>Pharmacology/Toxicology</subject><subject>Pharmacotherapy</subject><subject>Population</subject><subject>Quality of life</subject><subject>Questionnaires</subject><subject>Self image</subject><subject>Standard deviation</subject><subject>Success</subject><issn>1175-0561</issn><issn>1179-1888</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2020</creationdate><recordtype>article</recordtype><recordid>eNp9kV1LHDEUhoeiUD_6B3oVKAVvsp4kk8nM5WJtFVZW6eptyGbPaGRMtklG2X9v1hUKXgiBk4vnfTict6q-M5gwAHWaauBSUeBAAaTsqPhSHTCmOsratt17-0sKsmFfq8OUHqGQHJqDalw8IDnve7Q5kdCTubdIfxk3bMgiYnY-OE9gAvInmYXsgifl3YxmcHmz5WeuR1KQa5Md-uJ4cfmBXIUVRpOR5kD_4jNGJFPrkdyNw72JLh1X-70ZEn57n0fV7e_zxdkFnc3_XJ5NZ9QKEJnWCu2KNwJFvVRWNZJjI-oVYM8YE5LxmsMSoG1Nt2TcdKgMQ7GUKyta3gopjqqTnXcdw78RU9ZPLlkcBuMxjEnzuoZagWJQ0B8f0McwRl-2K1THBVeKb4V8R9kYUorY63V0TyZuNAO9bULvmtDluvqtCS1KSOxCqcD-HuN_9SepVxdtiOE</recordid><startdate>20201201</startdate><enddate>20201201</enddate><creator>Tyring, Stephen K.</creator><creator>Kircik, Leon</creator><creator>Pariser, David M.</creator><creator>Woolery-Lloyd, Heather C.</creator><creator>Harper, Julie C.</creator><creator>Bhatt, Varsha</creator><creator>Pillai, Radhakrishnan</creator><creator>Guenin, Eric</creator><general>Springer International Publishing</general><general>Springer Nature B.V</general><scope>AAYXX</scope><scope>CITATION</scope><scope>3V.</scope><scope>4T-</scope><scope>7X7</scope><scope>7XB</scope><scope>88E</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>BENPR</scope><scope>CCPQU</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>K9.</scope><scope>M0S</scope><scope>M1P</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>7X8</scope></search><sort><creationdate>20201201</creationdate><title>The Effects of Once-Daily Tretinoin 0.05% Lotion on Quality of Life in Patients with Moderate-to-Severe Acne Vulgaris</title><author>Tyring, Stephen K. ; Kircik, Leon ; Pariser, David M. ; Woolery-Lloyd, Heather C. ; Harper, Julie C. ; Bhatt, Varsha ; Pillai, Radhakrishnan ; Guenin, Eric</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c303t-47ecd263e34b7c7652e634d0ef1113512420b0088a9b12a9e7a1e3b5dc3828353</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2020</creationdate><topic>Acne</topic><topic>Clinical trials</topic><topic>Dermatology</topic><topic>Medicine</topic><topic>Medicine & Public Health</topic><topic>Original Research Article</topic><topic>Pharmacology/Toxicology</topic><topic>Pharmacotherapy</topic><topic>Population</topic><topic>Quality of life</topic><topic>Questionnaires</topic><topic>Self image</topic><topic>Standard deviation</topic><topic>Success</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Tyring, Stephen K.</creatorcontrib><creatorcontrib>Kircik, Leon</creatorcontrib><creatorcontrib>Pariser, David M.</creatorcontrib><creatorcontrib>Woolery-Lloyd, Heather C.</creatorcontrib><creatorcontrib>Harper, Julie C.</creatorcontrib><creatorcontrib>Bhatt, Varsha</creatorcontrib><creatorcontrib>Pillai, Radhakrishnan</creatorcontrib><creatorcontrib>Guenin, Eric</creatorcontrib><collection>CrossRef</collection><collection>ProQuest Central (Corporate)</collection><collection>Docstoc</collection><collection>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Medical Database (Alumni Edition)</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>ProQuest Central (Alumni)</collection><collection>ProQuest Central UK/Ireland</collection><collection>ProQuest Central</collection><collection>ProQuest One Community College</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Medical Database</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest Central China</collection><collection>MEDLINE - Academic</collection><jtitle>American journal of clinical dermatology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Tyring, Stephen K.</au><au>Kircik, Leon</au><au>Pariser, David M.</au><au>Woolery-Lloyd, Heather C.</au><au>Harper, Julie C.</au><au>Bhatt, Varsha</au><au>Pillai, Radhakrishnan</au><au>Guenin, Eric</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>The Effects of Once-Daily Tretinoin 0.05% Lotion on Quality of Life in Patients with Moderate-to-Severe Acne Vulgaris</atitle><jtitle>American journal of clinical dermatology</jtitle><stitle>Am J Clin Dermatol</stitle><date>2020-12-01</date><risdate>2020</risdate><volume>21</volume><issue>6</issue><spage>891</spage><epage>899</epage><pages>891-899</pages><issn>1175-0561</issn><eissn>1179-1888</eissn><abstract>Background
In two phase III clinical trials of patients with moderate-to-severe acne (NCT02932306, NCT02965456), tretinoin 0.05% lotion reduced inflammatory and noninflammatory lesions relative to vehicle lotion, with low potential for cutaneous irritation.
Objective
Data from these studies were analyzed post hoc to investigate the effects of tretinoin 0.05% lotion on patient-reported quality of life, as assessed using the Acne-Specific Quality of Life Questionnaire (Acne-QoL).
Methods
Mean changes from baseline to week 12 in Acne-QoL scores were analyzed in the pooled intent-to-treat population and a subgroup with treatment success (≥ 2-grade improvement on the Evaluator’s Global Severity Scale and rating of “clear” or “almost clear”). Pearson correlations were conducted in the pooled intent-to-treat population to assess the relationship between the Acne-QoL acne symptoms domain and each of the other three domains.
Results
In the pooled intent-to-treat population (
n
= 1640), greater mean improvements were found with tretinoin 0.05% lotion vs vehicle in all four domains: self-perception (mean change: 7.4 vs 6.7); role-emotional (6.8 vs 6.0); role-social (4.8 vs 4.6); acne symptoms (6.5 vs 5.6); all
p
< 0.05. Relative to the intent-to-treat population, participants who experienced treatment success with tretinoin 0.05% lotion had higher (better) mean Acne-QoL scores at week 12. Correlations between acne symptoms and the other three domains were found at baseline and week 12 (
p
< 0.05).
Conclusions
Participants with moderate-to-severe acne reported better quality of life after 12 weeks of treatment with tretinoin 0.05% lotion. Clinical improvements in acne symptoms may have contributed to these outcomes.
Trial Registration
ClinicalTrials.gov: NCT02932306, NCT02965456.</abstract><cop>Cham</cop><pub>Springer International Publishing</pub><doi>10.1007/s40257-020-00559-3</doi><tpages>9</tpages></addata></record> |
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| ispartof | American journal of clinical dermatology, 2020-12, Vol.21 (6), p.891-899 |
| issn | 1175-0561 1179-1888 |
| language | eng |
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| source | Springer Nature; Alma/SFX Local Collection |
| subjects | Acne Clinical trials Dermatology Medicine Medicine & Public Health Original Research Article Pharmacology/Toxicology Pharmacotherapy Population Quality of life Questionnaires Self image Standard deviation Success |
| title | The Effects of Once-Daily Tretinoin 0.05% Lotion on Quality of Life in Patients with Moderate-to-Severe Acne Vulgaris |
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