Acne Vulgaris Clinical Trial
— SAOfficial title:
Identifying the Genetic Predictors of Severe Acne Vulgaris and the Outcome of Oral Isotretinoin Treatment
Verified date | January 2017 |
Source | Duke University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 123 |
Est. completion date | August 2015 |
Est. primary completion date | August 2015 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 12 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Carolinas Medical Center Northeast Medical Arts Building | Concord | North Carolina |
United States | Dermatology Group of the Carolinas | Concord | North Carolina |
United States | Ada Jenkins Center | Davidson | North Carolina |
United States | Harrisburg Sleep Center | Harrisburg | North Carolina |
United States | Lake Norman Community Health Clinic | Huntersville | North Carolina |
United States | Kannapolis Internal Medicine | Kannapolis | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Duke University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Adverse reaccion 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 |
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