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Identifying the Genetic Predictors of Severe Acne Vulgaris and the Outcome of Oral Isotretinoin Treatment

Information source: Duke University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Acne Vulgaris; Isotretinoin

Phase: N/A

Status: Recruiting

Sponsored by: Duke University

Official(s) and/or principal investigator(s):
Russell Hall, MD, Principal Investigator, Affiliation: Duke Medicine Site Based Research Group

Overall contact:
Abha Singh, Phone: 704-250-5873, Email: abha.singh@duke.edu

Summary

The goal of this study is to enroll 250 participants that have joined the MURDOCK Study Horizon 1. 5 (Duke IRB Pro00011196) with a current or prior diagnosis of severe acne AND current or prior treatment with oral isotretinoin. All 250 participants will answer a 5-page questionnaire designed to collect information on the diagnosis of severe acne and response to oral isotretinoin treatment. The aim is to identify genetic predictors of severe acne vulgaris and the outcome of oral isotretinoin treatment.

Clinical Details

Official title: Identifying the Genetic Predictors of Severe Acne Vulgaris and the Outcome of Oral Isotretinoin Treatment

Study design: Observational Model: Case Control, Time Perspective: Retrospective

Primary outcome: Therapeutic response to isotretinoin

Secondary outcome: Adverse reaccion to isotretinoin

Detailed description: Acne vulgaris is an under-studied common genetic disease with tremendous economic consequences. Acne vulgaris is one of the most common skin conditions treated by doctors. It affects 40-50 million people in the USA, with prevalence as high as 85% (recent study from Iran was 93%) in teenagers; 18% of woman have late onset (>25yr) acne vulgaris. Severe acne has a life-long psychosocial impact due to the significant scarring. Severe acne can also be associated with severe systemic inflammatory disease with fever, sterile osteomyelitis, inflammatory arthritis and other signs of systemic inflammatory responses. Some of these syndromes in Mendelian form (e. g. PAPA syndrome) have known genetic defects. Finally, while the data are inconclusive, there have been many suggestions that diet can exacerbate acne in some patients. The standard of care treatment for severe acne is systemic retinoid therapy, which, is usually, but not always effective. Unfortunately, systemic retinoid treatment is associated with significant toxicity, including common cutaneous adverse effects (dry lips, eyes, skin fragility), less common laboratory abnormalities such as elevated blood lipids, liver function abnormalities, and severe predictable teratogenicity. In addition, systemic therapy with retinoids has been associated with systemic diseases such as clinical depression, suicide, and inflammatory bowel disease, however the mechanisms and significance of these associations has not been determined. Given the frequency and severity of severe acne, the predictable severe toxicity of systemic retinoid therapy, and the already demonstrated genetic associations found in Mendelian forms of severe acne, it seems likely that significant genetic risk factors may be identified in patients with severe acne which would promote new and safer therapy, including dietary adjustment.

Eligibility

Minimum age: 12 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Diagnosed with severe acne while age > 12 and < 18, and

- Completed at least one course of oral isotretinoin treatment; OR started treatment

but discontinued prior to completion due to adverse side effects (with the exception

of dry skin - see "exclusion criteria"); OR are currently undergoing and plan to

complete treatment Exclusion Criteria:

- Patients who are not willing to participate in this study

- Patients who experienced inflammatory bowel disease (IBD) prior to oral isotretinoin

treatment

- Patients who did not complete the oral isotretinoin treatment because of pregnancy,

dry skin, or reasons other than adverse side effects listed above

- Patients who are not willing to or cannot provide a blood sample for Murdock Study

Locations and Contacts

Abha Singh, Phone: 704-250-5873, Email: abha.singh@duke.edu

Carolinas Medical Center Northeast Medical Arts Building, Concord, North Carolina 28025, United States; Recruiting
Abha Singh, Phone: 704-250-5861, Ext: 5873, Email: abha.singh@duke.edu

Dermatology Group of the Carolinas, Concord, North Carolina 28025, United States; Recruiting
Abha Singh, Phone: 704-250-5873, Email: abha.singh@dm.duke.edu
Leah Bouk, Phone: 919-451-5051, Email: leah.bouk@duke.edu

Ada Jenkins Center, Davidson, North Carolina 28036, United States; Recruiting
Abha Singh, Phone: 704-250-5861, Ext: 5873, Email: abha.singh@duke.edu

Harrisburg Sleep Center, Harrisburg, North Carolina 28075, United States; Recruiting
Abha Singh, Phone: 704-250-5861, Ext: 5873, Email: abha.singh@duke.edu

Lake Norman Community Health Clinic, Huntersville, North Carolina 28078, United States; Recruiting
Abha Singh, CCRC, Phone: 704-230-5861, Ext: 5873, Email: abha.singh@dm.duke.edu

Kannapolis Internal Medicine, Kannapolis, North Carolina 28081, United States; Recruiting
Abha Singh, Phone: 704-250-5861, Ext: 5873, Email: abha.singh@duke.edu

Additional Information

Murdock Study Severe Acne Study

Starting date: September 2011
Last updated: July 17, 2015

Page last updated: August 23, 2015

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