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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01629797
Other study ID # STU64905
Secondary ID
Status Completed
Phase N/A
First received June 26, 2012
Last updated April 29, 2013
Start date May 2012
Est. completion date November 2012

Study information

Verified date April 2013
Source Northwestern University
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

Acne vulgaris is a chronic inflammatory disorder of the skin in the pilosebaceous unit of the hair follicle, associated with oil production. It is found across skin types and is present in 85% of adolescents, representing a large affected population. Because of the universal nature of the disease, 36.3% of acne patients come from backgrounds other than Caucasian.

The purpose of this study is to examine patient knowledge about acne in different populations and to assess the effectiveness of a teaching intervention on acne knowledge. The investigators aim is to better understand and subsequently reduce any potential health disparities within the minority populations.

This project will evaluate differences in acne knowledge between different ethnic groups, and the efficacy of an educational intervention. Subjects will first complete a survey evaluating their knowledge of acne and how acne affects them psychosocially before an educational intervention. Immediately following the intervention, the patient's knowledge of acne will be evaluated again. Finally, two months after the intervention, a phone call will be made evaluating their retention of the education materials and their quality of life related to psychosocial effects of acne. Investigating this educational intervention and any current disparities in acne education and understanding will better allow us to educate and treat acne patients in the future.


Recruitment information / eligibility

Status Completed
Enrollment 100
Est. completion date November 2012
Est. primary completion date November 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion criteria:

- Subjects ages 18 years of age and older and able to give consent

- Subjects with a diagnosis of acne vulgaris

Exclusion criteria:

- Subjects who are not proficient in English

- Subjects who were unable to give informed consent

- Subjects who do not have a diagnosis of acne vulgaris

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label


Related Conditions & MeSH terms


Intervention

Behavioral:
Educational script on Acne
An educational script on Acne will be presented by investigator

Locations

Country Name City State
United States Northwestern University Department of Dermatology Chicago Illinois

Sponsors (1)

Lead Sponsor Collaborator
Northwestern University

Country where clinical trial is conducted

United States, 

References & Publications (6)

Callender VD. Acne in ethnic skin: special considerations for therapy. Dermatol Ther. 2004;17(2):184-95. Review. — View Citation

Cheng CE, Irwin B, Mauriello D, Liang L, Pappert A, Kimball AB. Self-reported acne severity, treatment, and belief patterns across multiple racial and ethnic groups in adolescent students. Pediatr Dermatol. 2010 Sep-Oct;27(5):446-52. doi: 10.1111/j.1525-1470.2010.01286.x. Epub 2010 Aug 26. — View Citation

Dréno B. Assessing quality of life in patients with acne vulgaris: implications for treatment. Am J Clin Dermatol. 2006;7(2):99-106. Review. — View Citation

Hanna S, Sharma J, Klotz J. Acne vulgaris: more than skin deep. Dermatol Online J. 2003 Aug;9(3):8. — View Citation

Tan JK, Vasey K, Fung KY. Beliefs and perceptions of patients with acne. J Am Acad Dermatol. 2001 Mar;44(3):439-45. — View Citation

Williams HC, Dellavalle RP, Garner S. Acne vulgaris. Lancet. 2012 Jan 28;379(9813):361-72. doi: 10.1016/S0140-6736(11)60321-8. Epub 2011 Aug 29. Review. Erratum in: Lancet. 2012 Jan 28;379(9813):314. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Correct Responses to Questionnaire Items Immediately Before and After and Educational Lecture In order to evaluate the immediate effect of an educational lecture about acne, subjects completed a questionnaire to assess knowledge about acne immediately before and after the educational lecture. The number of correct responses to each questionnaire item was calculated pre- and post-educational lecture. immediately before and after an educational lecture No
Secondary Number of Correct Responses to Questionnaire Items Before and 2 Months After an Educational Lecture In order to evaluate the long-term effect of an educational lecture about acne, subjects completed a questionnaire to assess knowledge about acne immediately before and two months after the educational lecture. The number of correct responses to each questionnaire item was calculated pre- and two months post-educational lecture. before and 2 months after an educational lecture No
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