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

NCT01727440 | Completed DMC

• 1 other identifier: Pro00030862
• Study Type: observational
• Target: 123
• Locations: 1 country
• Sites: 6

Brief 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.

Conditions

Acne Vulgaris; Isotretinoin

Keywords

severe acne; severe acne vulgaris; acne; acne vulgaris; isotretinoin; Accutane; Sortret; Amnesteem; Claravis; Clarus; Decutan; Isotane; Izotek; Oratane; Isotret; Roaccutane

Outcome Measures

Primary Outcomes (1)

• Therapeutic response to isotretinoin

  All 250 patients with severe acne will be genotyped using the Illumina 610 BeadChip. Whole-exome sequencing will be performed on 100 extremely severe acne vulgaris patients, selected based on severity and response to oral isotretinoin treatment. A case-control GWAS analysis will be performed (250 recruited patients vs. 1000 normal controls of convenience available in other studies at CHGV). Additionally, an association analyses will be conducted using complete exome sequencing data for the most severe cases, compared with controls of convenience (as an extreme trait in the population, there is a reasonable expectation of discovery of any important variants, rare or common). This analysis would also include targeted analysis on available drug response data (efficacy and adverse response).

  10 months

Secondary Outcomes (1)

• Adverse reaccion to isotretinoin

  10 months

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants must enroll or have enrolled in the MURDOCK Study Community Registry and Biorepository prior to joining this Severe Acne Study. At the MURDOCK Study visit, or after the participant has enrolled in the MURDOCK Study, they will be asked (either in person or via phone) if they would be willing to join the Severe Acne Study. Participants between ages 12 and 18 may also join the MURDOCK Study if they meet the eligibility criteria for this Severe Acne Study (a pediatric consent form will be used).

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Duke University: lead

Study Sites (6)

Carolinas Medical Center Northeast Medical Arts Building

Concord, North Carolina, 28025, United States

Location

Dermatology Group of the Carolinas

Concord, North Carolina, 28025, United States

Location

Ada Jenkins Center

Davidson, North Carolina, 28036, United States

Location

Harrisburg Sleep Center

Harrisburg, North Carolina, 28075, United States

Location

Lake Norman Community Health Clinic

Huntersville, North Carolina, 28078, United States

Location

Kannapolis Internal Medicine

Kannapolis, North Carolina, 28081, United States

Location

Related Links

• Murdock Study Severe Acne Study

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood collected in three 2-mL EDTA tubes

MeSH Terms

Conditions

Acne Vulgaris

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases

Study Officials

• Russell Hall, MD

  Duke Medicine Site Based Research Group

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2012
• First Posted: November 16, 2012
• Study Start: September 1, 2011
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: August 24, 2017

Record last verified: 2017-01

Locations

US (6)