NCT01835210

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2012

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2012

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

April 16, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 18, 2013

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
Last Updated

January 28, 2016

Status Verified

January 1, 2016

Enrollment Period

1.8 years

First QC Date

April 16, 2013

Last Update Submit

January 26, 2016

Conditions

Outcome Measures

Primary Outcomes (1)

  • Teenager's perception of the severity of their acne.

    Teenagers will complete a Likert scale for assessment of acne severity.

    one visit

Secondary Outcomes (2)

  • Quality of Life

    one visit

  • Quality of Life

    One visit

Study Arms (1)

Quality of life

Teenager with acne vulgaris This is an observational study, in which the disease of interest is acne vulgaris.

Eligibility Criteria

Age12 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • Between 12 and 17 years of age
  • diagnosis of acne by a pediatric dermatologist
  • ability to read and understand English
  • age appropriate development

You may not qualify if:

  • developmental delay

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ann & Robert H. Lurie Children's Hospital of Chicago

Chicago, Illinois, 60611, United States

Location

Related Publications (9)

  • 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.

    PMID: 9293656BACKGROUND
  • Dreno B, Poli F. Epidemiology of acne. Dermatology. 2003;206(1):7-10. doi: 10.1159/000067817. No abstract available.

    PMID: 12566799BACKGROUND
  • 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. doi: 10.1111/j.1468-3083.2005.01344.x.

    PMID: 16405607BACKGROUND
  • 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. doi: 10.1111/j.1365-2133.2006.07185.x.

    PMID: 16792766BACKGROUND
  • Dalgard 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.

    PMID: 19119094BACKGROUND
  • 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.

    PMID: 20844551BACKGROUND
  • 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.

    PMID: 22097994BACKGROUND
  • 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.

    PMID: 18424379BACKGROUND
  • 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.

    PMID: 20713817BACKGROUND

MeSH Terms

Conditions

Acne Vulgaris

Condition Hierarchy (Ancestors)

Acneiform EruptionsSkin DiseasesSkin and Connective Tissue DiseasesSebaceous Gland Diseases

Study Officials

  • Jennifer Sorrell, MD

    Ann & Robert H Lurie Children's Hospital of Chicago

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D.

Study Record Dates

First Submitted

April 16, 2013

First Posted

April 18, 2013

Study Start

August 1, 2012

Primary Completion

June 1, 2014

Study Completion

January 1, 2015

Last Updated

January 28, 2016

Record last verified: 2016-01

Locations