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Trial record 3 of 4 for:    "Ichthyosis vulgaris"

Genetic Screening for Filaggrin Mutation in Atopic Dermatitis and Ichthyosis Vulgaris in the African American Population

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ClinicalTrials.gov Identifier: NCT01016106
Recruitment Status : Completed
First Posted : November 18, 2009
Results First Posted : June 20, 2013
Last Update Posted : May 1, 2015
Sponsor:
Collaborator:
ViraCor Laboratories
Information provided by (Responsible Party):
Amy Paller, Northwestern University

Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: Double (Participant, Outcomes Assessor);   Primary Purpose: Diagnostic
Conditions: Atopic Dermatitis
Ichthyosis Vulgaris
Intervention: Genetic: Buccal Swab

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
African American (AA) Control Subjects African American subjects with no personal or family history of ichthyosis vulgaris or atopy. Buccal swabs were obtained from each subject for deoxyribonucleic acid (DNA) analysis.
AA Subjects With Atopic Dermatitis and Ichthyosis Vulgaris African American subjects with a diagnosis of atopic dermatitis and ichthyosis vulgaris. Buccal swabs were obtained from each subject for deoxyribonucleic acid (DNA) analysis.

Participant Flow:   Overall Study
    African American (AA) Control Subjects   AA Subjects With Atopic Dermatitis and Ichthyosis Vulgaris
STARTED   17   18 
COMPLETED   17   18 
NOT COMPLETED   0   0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
African American (AA) Control Subjects African American subjects with no personal or family history of ichthyosis vulgaris or atopy. Buccal swabs were obtained from each subject for DNA analysis.
AA Subjects With Atopic Dermatitis and Ichthyosis Vulgaris African American subjects with a diagnosis of atopic dermatitis and ichthyosis vulgaris. Buccal swabs were obtained from each subject for DNA analysis.
Total Total of all reporting groups

Baseline Measures
   African American (AA) Control Subjects   AA Subjects With Atopic Dermatitis and Ichthyosis Vulgaris   Total 
Overall Participants Analyzed 
[Units: Participants]
 17   18   35 
Age 
[Units: Participants]
     
<=18 years   2   17   19 
Between 18 and 65 years   8   1   9 
>=65 years   7   0   7 
Gender 
[Units: Participants]
     
Female   10   12   22 
Male   7   6   13 
Region of Enrollment 
[Units: Participants]
     
United States   17   18   35 


  Outcome Measures

1.  Primary:   Heterozygous for Filaggrin (FLG) Null Mutations   [ Time Frame: 1 month ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Mandy Browning
Organization: Northwestern University
phone: 312-695-6829
e-mail: mandybrowning2015@u.northwestern.edu


Publications of Results:

Responsible Party: Amy Paller, Northwestern University
ClinicalTrials.gov Identifier: NCT01016106     History of Changes
Other Study ID Numbers: CMH 2010-14049
First Submitted: November 17, 2009
First Posted: November 18, 2009
Results First Submitted: April 30, 2013
Results First Posted: June 20, 2013
Last Update Posted: May 1, 2015