AcneNCT01835210
Effect of Acne Vulgaris on Quality of Life of Teenagers Compared to Parent Perceived Effect on Quality of Life
An observational study of Acne and Quality of Life, run by Ann & Robert H Lurie Children's Hospital of Chicago at 1 site in United States.
Trial summary
Acne vulgaris is a common problem in the adolescent community. Past research has shown that acne affects teenager's self-esteem and mood. However, no research has evaluated the parent perception of their teenager's acne in comparison to the severity of acne and the patient's own reported quality of life. Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Acne, Quality of Life
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2012to Jan 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: Subjects will be recruited from the pediatric dermatology clinic at Ann and Robert H. Lurie Children's Hospital of Chicago. Teenagers must be between 12 and 17 years old, and have a diagnosis of acne by a pediatric dermatologist.
Who may be able to join
- Between 12 and 17 years of age
- diagnosis of acne by a pediatric dermatologist
- ability to read and understand English
- age appropriate development
Who cannot join
- developmental delay
Trial locations and contacts
1 site in 1 country.
United States1 site
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611
About this study
Acne vulgaris is a common problem in the adolescent community. Past research has shown that acne affects teenager's self-esteem and mood. However, no research has evaluated the parent perception of their teenager's acne in comparison to the severity of acne and the patient's own reported quality of life. It is hypothesized that parents of teenagers underestimate how much acne vulgaris affects their teenager's skin disease-related quality of life. Also that teenager's perception of the severity of their acne is greater versus their parent's perception. We believe that increased acne severity based on clinician assessment will correlate with worse quality of life. Teenagers between 12 and 17 years old with a diagnosis of acne by a pediatric dermatologist will be enrolled in this study. The study consists of 1 visit, questions regarding demographics, assessment of the teen's acne, the Skindex-Teen quality of life survey (modified for parents), and 2 Likert scales will be completed. In addition, the clinician will score the teen's acne using the standardized Investigator Global Assessment tool. Statistical analysis will compare teen subject answers to the Skindex-Teen with their parent's answers. Also analyzed will be the severity of acne and differences between the clinician IGA score and Skindex-Teen responses
Read the detailed description
Acne vulgaris is a prevalent problem in the adolescent community, with the literature citing prevalence between 35 to 90% at some stage and some studies showing the prevalence of comedonal acne approaching 100%. Mean age of onset of acne in girls is 11 years and in boys is 12 years. We know that being afflicted with acne places a significant burden on the life of a teenager, and studies have shown diminished quality of life and increased presence of depressive symptoms in teens with acne. Dalgard et al looked at effects of moderate and severe acne on self-esteem and body satisfaction in adolescents. In their study, girls with acne reported significantly higher levels of depressive symptoms, greater feelings of uselessness, and lower self-attitude, sense of pride, self-worth, and body satisfaction compared to girls without acne; a similar tendency was observed in boys. Halvorsen et al performed a cross-sectional questionnaire-based study to evaluate psychological effects of acne in adolescents aged 18-19 years old. They found that in the 14% of participants who had substantial acne- defined as self reported a lot or very much acne, suicidal ideation was twice as frequently reported in girls and three times more frequently reported in boys compared to subjects of either gender with no or a little acne per patient self report. Suicidal ideation was significantly associated with substantial acne with an odds ratio of 1.80. To our knowledge, there has been no research that evaluates parent perception of their teenager's acne in comparison to clinical data points such as investigator global assessment or patient-reported quality of life. Nor have there been data comparing investigator global assessment of acne with patient-reported Likert scale of acne severity. Magin et al looked at 108 patients, of whom 41 had acne and assessed difference in clinician evaluation of acne severity (using the Leeds method as an indicator of severity) compared to patient assessment of acne. They found a moderately poor agreement between objective clinician assessment and patient self-assessment of acne severity (weighted kappa 0.35, with 95% CI 0.1981 - 0.5084). There have been studies as well showing that patients with acne often underestimate the severity of their acne. Smithard A et al studied 317 students aged 14-16 and found that students tended to underestimate their acne severity, with only 66% of patients with mild acne via Leeds scoring self-determining that they had acne. Demircay et al looked at physician's assessment of acne severity, by means of Global Acne Grading System (GAGS) scoring of 0 as none, 1-18 as mild, 19-30 as moderate and > 31 as severe acne. Patient's assessment of acne severity used a 10-point Likert-type scale. Patients were asked how severe their acne was, and 0 denoted "no acne" and 9 denoted "most severe acne that can be imagined". Results of the Likert-type scale were analyzed in four groups: 0 = none, 1-3 = mild, 4-6 = moderate, 7-9 = severe. No correlation was found between physician GAGS scores and any of the patients' own assessments. Smidt et al developed and validated a quality of life index for adolescents with skin disease, using the adult-oriented Skindex and Skindex-16 instruments as models. Skindex-Teen is a 21-item questionnaire, self-administered by the patient and generally is able to be completed in 5 to 10 minutes. The instrument inquires about the patient's perceptions of his/her primary skin condition during the previous 4 weeks. Standardized responses consist of 4-category choices relating to frequency with 0 being never and 4 being all the time. Analysis demonstrated that the refined Skindex-Teen was a valid and effective way of measuring the effects of skin disease in adolescents. A Likert scale is a type of psychometric scale frequently used in psychology questionnaires. On a questionnaire, a Likert scale asks subjects to circle, check or mark the number that most closely correlates to their feelings on a scale.
We speculate that parents of teenagers underestimate how much acne vulgaris affects their teenager's skin disease-related quality of life. By having both the teenage patient and his/her parent independently complete the Skindex-Teen questionnaire at the same time point, we will be able to assess potential differences in how teenagers perceive their acne and how their parents perceive the impact of the teen's acne on quality of life and correlate this with clinical acne severity.
- Conditions
- Acne, Quality of Life
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Quality of life | Teenager with acne vulgaris This is an observational study, in which the disease of interest is acne vulgaris. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Teenager's perception of the severity of their acne.
Teenagers will complete a Likert scale for assessment of acne severity.
Measured: one visit
Secondary outcomes (2)
Quality of Life
Parents will each complete Skindex-Teen questionnaires to evaluate the teenager's quality of life.
Measured: one visit
Quality of Life
Teenager's will each complete Skindex-Teen questionnaires to evaluate the teenager's quality of life.
Measured: One visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2013 (estimated)
- Study startAug 2012
- Primary completionJun 2014
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for AcneStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ann & Robert H Lurie Children's Hospital of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jennifer Sorrell, Ann & Robert H Lurie Children's Hospital of Chicago
- Investigators
- Jennifer Sorrell, MD, Principal investigator, Ann & Robert H Lurie Children's Hospital of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01835210
- Sponsor's protocol ID
- 2012-15072
- Other IDs
- 2012-15072
- Status last verified
- Jan 2016
- First submitted
- 16 Apr 2013
- Last updated
- 28 Jan 2016
- Results posted
- No
Publications
Stathakis V, Kilkenny M, Marks R. Descriptive epidemiology of acne vulgaris in the community. Australas J Dermatol. 1997 Aug;38(3):115-23. doi: 10.1111/j.1440-0960.1997.tb01126.x.
PubMed 9293656Dreno B, Poli F. Epidemiology of acne. Dermatology. 2003;206(1):7-10. doi: 10.1159/000067817. No abstract available.
PubMed 12566799Walker N, Lewis-Jones MS. Quality of life and acne in Scottish adolescent schoolchildren: use of the Children's Dermatology Life Quality Index (CDLQI) and the Cardiff Acne Disability Index (CADI). J Eur Acad Dermatol Venereol. 2006 Jan;20(1):45-50. doi: 10.1111/j.1468-3083.2005.01344.x.
PubMed 16405607Beattie PE, Lewis-Jones MS. A comparative study of impairment of quality of life in children with skin disease and children with other chronic childhood diseases. Br J Dermatol. 2006 Jul;155(1):145-51. doi: 10.1111/j.1365-2133.2006.07185.x.
PubMed 16792766Dalgard F, Gieler U, Holm JO, Bjertness E, Hauser S. Self-esteem and body satisfaction among late adolescents with acne: results from a population survey. J Am Acad Dermatol. 2008 Nov;59(5):746-51. doi: 10.1016/j.jaad.2008.07.013.
PubMed 19119094Halvorsen JA, Stern RS, Dalgard F, Thoresen M, Bjertness E, Lien L. Suicidal ideation, mental health problems, and social impairment are increased in adolescents with acne: a population-based study. J Invest Dermatol. 2011 Feb;131(2):363-70. doi: 10.1038/jid.2010.264. Epub 2010 Sep 16.
PubMed 20844551Magin PJ, Pond CD, Smith WT, Watson AB, Goode SM. Correlation and agreement of self-assessed and objective skin disease severity in a cross-sectional study of patients with acne, psoriasis, and atopic eczema. Int J Dermatol. 2011 Dec;50(12):1486-90. doi: 10.1111/j.1365-4632.2011.04883.x.
PubMed 22097994Demircay Z, Seckin D, Senol A, Demir F. Patient's perspective: an important issue not to be overlooked in assessing acne severity. Eur J Dermatol. 2008 Mar-Apr;18(2):181-4. doi: 10.1684/ejd.2008.0384.
PubMed 18424379Smidt AC, Lai JS, Cella D, Patel S, Mancini AJ, Chamlin SL. Development and validation of Skindex-Teen, a quality-of-life instrument for adolescents with skin disease. Arch Dermatol. 2010 Aug;146(8):865-9. doi: 10.1001/archdermatol.2010.161.
PubMed 20713817
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Acne Vulgaris on Quality of Life of Teenagers Compared to Parent Perceived Effect on Quality of Life
- ClinicalTrials.gov ID
- NCT01835210
- Acronym / sponsor ID
- 2012-15072
- Conditions
- Acne, Quality of Life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ann & Robert H Lurie Children's Hospital of ChicagoUniversity, hospital or other
- Study start
- Aug 2012
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 18 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Acne vulgaris is a common problem in the adolescent community. Past research has shown that acne affects teenager's self-esteem and mood. However, no research has evaluated the parent perception of their teenager's acne in comparison to the severity of acne and the patient's own reported quality of life. It is hypothesized that parents of teenagers underestimate how much acne vulgaris affects their teenager's skin disease-related quality of life. Also that teenager's perception of the severity of their acne is greater versus their parent's perception. We believe that increased acne severity based on clinician assessment will correlate with worse quality of life. Teenagers between 12 and 17 years old with a diagnosis of acne by a pediatric dermatologist will be enrolled in this study. The study consists of 1 visit, questions regarding demographics, assessment of the teen's acne, the Skindex-Teen quality of life survey (modified for parents), and 2 Likert scales will be completed. In addition, the clinician will score the teen's acne using the standardized Investigator Global Assessment tool. Statistical analysis will compare teen subject answers to the Skindex-Teen with their parent's answers. Also analyzed will be the severity of acne and differences between the clinician IGA score and Skindex-Teen responses
Detailed description
Acne vulgaris is a prevalent problem in the adolescent community, with the literature citing prevalence between 35 to 90% at some stage and some studies showing the prevalence of comedonal acne approaching 100%. Mean age of onset of acne in girls is 11 years and in boys is 12 years. We know that being afflicted with acne places a significant burden on the life of a teenager, and studies have shown diminished quality of life and increased presence of depressive symptoms in teens with acne. Dalgard et al looked at effects of moderate and severe acne on self-esteem and body satisfaction in adolescents. In their study, girls with acne reported significantly higher levels of depressive symptoms, greater feelings of uselessness, and lower self-attitude, sense of pride, self-worth, and body satisfaction compared to girls without acne; a similar tendency was observed in boys. Halvorsen et al performed a cross-sectional questionnaire-based study to evaluate psychological effects of acne in adolescents aged 18-19 years old. They found that in the 14% of participants who had substantial acne- defined as self reported a lot or very much acne, suicidal ideation was twice as frequently reported in girls and three times more frequently reported in boys compared to subjects of either gender with no or a little acne per patient self report. Suicidal ideation was significantly associated with substantial acne with an odds ratio of 1.80. To our knowledge, there has been no research that evaluates parent perception of their teenager's acne in comparison to clinical data points such as investigator global assessment or patient-reported quality of life. Nor have there been data comparing investigator global assessment of acne with patient-reported Likert scale of acne severity. Magin et al looked at 108 patients, of whom 41 had acne and assessed difference in clinician evaluation of acne severity (using the Leeds method as an indicator of severity) compared to patient assessment of acne. They found a moderately poor agreement between objective clinician assessment and patient self-assessment of acne severity (weighted kappa 0.35, with 95% CI 0.1981 - 0.5084). There have been studies as well showing that patients with acne often underestimate the severity of their acne. Smithard A et al studied 317 students aged 14-16 and found that students tended to underestimate their acne severity, with only 66% of patients with mild acne via Leeds scoring self-determining that they had acne. Demircay et al looked at physician's assessment of acne severity, by means of Global Acne Grading System (GAGS) scoring of 0 as none, 1-18 as mild, 19-30 as moderate and > 31 as severe acne. Patient's assessment of acne severity used a 10-point Likert-type scale. Patients were asked how severe their acne was, and 0 denoted "no acne" and 9 denoted "most severe acne that can be imagined". Results of the Likert-type scale were analyzed in four groups: 0 = none, 1-3 = mild, 4-6 = moderate, 7-9 = severe. No correlation was found between physician GAGS scores and any of the patients' own assessments. Smidt et al developed and validated a quality of life index for adolescents with skin disease, using the adult-oriented Skindex and Skindex-16 instruments as models. Skindex-Teen is a 21-item questionnaire, self-administered by the patient and generally is able to be completed in 5 to 10 minutes. The instrument inquires about the patient's perceptions of his/her primary skin condition during the previous 4 weeks. Standardized responses consist of 4-category choices relating to frequency with 0 being never and 4 being all the time. Analysis demonstrated that the refined Skindex-Teen was a valid and effective way of measuring the effects of skin disease in adolescents. A Likert scale is a type of psychometric scale frequently used in psychology questionnaires. On a questionnaire, a Likert scale asks subjects to circle, check or mark the number that most closely correlates to their feelings on a scale.
We speculate that parents of teenagers underestimate how much acne vulgaris affects their teenager's skin disease-related quality of life. By having both the teenage patient and his/her parent independently complete the Skindex-Teen questionnaire at the same time point, we will be able to assess potential differences in how teenagers perceive their acne and how their parents perceive the impact of the teen's acne on quality of life and correlate this with clinical acne severity.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Quality of life | – | –Teenager with acne vulgaris This is an observational study, in which the disease of interest is acne vulgaris. |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Subjects will be recruited from the pediatric dermatology clinic at Ann and Robert H. Lurie Children's Hospital of Chicago. Teenagers must be between 12 and 17 years old, and have a diagnosis of acne by a pediatric dermatologist.
Key inclusion criteria (4 listed)
- Between 12 and 17 years of age
- diagnosis of acne by a pediatric dermatologist
- ability to read and understand English
- age appropriate development
Key exclusion criteria (1 listed)
- developmental delay
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Teenager's perception of the severity of their acne.
Time frame: one visit
Teenagers will complete a Likert scale for assessment of acne severity.
2 secondary outcomes
Quality of Life
Time frame: one visit
Quality of Life
Time frame: One visit
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2016.
- Background: PubMed 9293656Stathakis V, Kilkenny M, Marks R. Descriptive epidemiology of acne vulgaris in the community. Australas J Dermatol. 1997 Aug;38(3):115-23. doi: 10.1111/j.1440-0960.1997.tb01126.x.
- Background: PubMed 12566799Dreno B, Poli F. Epidemiology of acne. Dermatology. 2003;206(1):7-10. doi: 10.1159/000067817. No abstract available.
- Background: PubMed 16405607Walker N, Lewis-Jones MS. Quality of life and acne in Scottish adolescent schoolchildren: use of the Children's Dermatology Life Quality Index (CDLQI) and the Cardiff Acne Disability Index (CADI). J Eur Acad Dermatol Venereol. 2006 Jan;20(1):45-50. doi: 10.1111/j.1468-3083.2005.01344.x.
- Background: PubMed 16792766Beattie PE, Lewis-Jones MS. A comparative study of impairment of quality of life in children with skin disease and children with other chronic childhood diseases. Br J Dermatol. 2006 Jul;155(1):145-51. doi: 10.1111/j.1365-2133.2006.07185.x.
- Background: PubMed 19119094Dalgard F, Gieler U, Holm JO, Bjertness E, Hauser S. Self-esteem and body satisfaction among late adolescents with acne: results from a population survey. J Am Acad Dermatol. 2008 Nov;59(5):746-51. doi: 10.1016/j.jaad.2008.07.013.
- Background: PubMed 20844551Halvorsen JA, Stern RS, Dalgard F, Thoresen M, Bjertness E, Lien L. Suicidal ideation, mental health problems, and social impairment are increased in adolescents with acne: a population-based study. J Invest Dermatol. 2011 Feb;131(2):363-70. doi: 10.1038/jid.2010.264. Epub 2010 Sep 16.
- Background: PubMed 22097994Magin PJ, Pond CD, Smith WT, Watson AB, Goode SM. Correlation and agreement of self-assessed and objective skin disease severity in a cross-sectional study of patients with acne, psoriasis, and atopic eczema. Int J Dermatol. 2011 Dec;50(12):1486-90. doi: 10.1111/j.1365-4632.2011.04883.x.
- Background: PubMed 18424379Demircay Z, Seckin D, Senol A, Demir F. Patient's perspective: an important issue not to be overlooked in assessing acne severity. Eur J Dermatol. 2008 Mar-Apr;18(2):181-4. doi: 10.1684/ejd.2008.0384.
- Background: PubMed 20713817Smidt AC, Lai JS, Cella D, Patel S, Mancini AJ, Chamlin SL. Development and validation of Skindex-Teen, a quality-of-life instrument for adolescents with skin disease. Arch Dermatol. 2010 Aug;146(8):865-9. doi: 10.1001/archdermatol.2010.161.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer Sorrell, MD principal investigator
Ann & Robert H Lurie Children's Hospital of Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acne and Quality of Life, run by Ann & Robert H Lurie Children's Hospital of Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Teenager's perception of the severity of their acne. (time frame: one visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01835210, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2016.