Effect of Acne Vulgaris on Quality of Life of Teenagers Compared to Parent Perceived Effect on Quality of Life

Quality of Life Clinical Trial

Official title:

Effect of Acne Vulgaris on Quality of Life of Teenagers Compared to Parent Perceived Effect on Quality of Life

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01835210
• Other study ID #: 2012-15072
• Secondary ID: 2012-15072
• Status: Completed
• Phase: N/A
• First received: April 16, 2013
• Last updated: January 26, 2016
• Start date: August 2012
• Est. completion date: January 2015

Study information

• Verified date: January 2016
• Source: Ann & Robert H Lurie Children's Hospital of Chicago
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical 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. 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: January 2015
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years to 17 Years

Eligibility

Inclusion Criteria:

• Between 12 and 17 years of age

• diagnosis of acne by a pediatric dermatologist

• ability to read and understand English

• age appropriate development

Exclusion Criteria:

• developmental delay

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Acne
• Acne Vulgaris
• Quality of Life

Locations

Country	Name	City	State
United States	Ann & Robert H. Lurie Children's Hospital of Chicago	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Ann & Robert H Lurie Children's Hospital of Chicago

Country where clinical trial is conducted

United States, 

References & Publications (9)

Beattie 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. — View Citation

Dalgard F, Gieler U, Holm JØ, 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. — View Citation

Demircay 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. — View Citation

Dreno B, Poli F. Epidemiology of acne. Dermatology. 2003;206(1):7-10. — View Citation

Halvorsen 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. — View Citation

Magin 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. — View Citation

Smidt 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. — View Citation

Stathakis V, Kilkenny M, Marks R. Descriptive epidemiology of acne vulgaris in the community. Australas J Dermatol. 1997 Aug;38(3):115-23. Review. — View Citation

Walker 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Teenager's perception of the severity of their acne.	Teenagers will complete a Likert scale for assessment of acne severity.	one visit	No
Secondary	Quality of Life	Parents will each complete Skindex-Teen questionnaires to evaluate the teenager's quality of life.	one visit	No
Secondary	Quality of Life	Teenager's will each complete Skindex-Teen questionnaires to evaluate the teenager's quality of life.	One visit	No