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

Acne Vulgaris research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Acne Vulgaris

Isotretinoin

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Study Status

Completed

Start Date: September 2011

Completed Date: August 2015

Phase:

Type: Observational

Design:

Primary Outcome: Therapeutic response to isotretinoin

Secondary Outcome: Adverse reaccion to isotretinoin

Study sponsors, principal investigator, and references

Principal Investigator: Russell Hall, MD

Lead Sponsor: Duke University

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01727440

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