Back to resultsComparison Between Interactive Internet-based Education and Counseling for the Management of Acne With That of Internet-based Education Alone
Primary Purpose
Acne Vulgaris
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Virtual Counseling
Sponsored by
About this trial
This is an interventional treatment trial for Acne Vulgaris
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of mild to moderate acne vulgaris
- 13 years of age or older at time of assent, may be men or women.
- Able read and understand English.
- Able to hear and see the educational videos.
- Access to computer with Internet access.
- Capable of giving informed consent.
- Not currently using any prescription acne treatment.
Exclusion Criteria:
- Non-English speaking individuals.
- Self-reported exposure to environmental or chemical comedogenic agents
- Women with self-reported hyperandrogenism (e.g., PCOS)
- Women self-reporting current use of any form of specific acne-directed hormonal therapy
- Men or women with self-reported history of Cushing syndrome or congenital adrenal hyperplasia
Sites / Locations
- University of California, Davis
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Online Education
Online Education & Virtual Counseling
Arm Description
Online virtual counseling
Outcomes
Primary Outcome Measures
Acne Lesion Counts (Inflammatory and Non-inflammatory)
Secondary Outcome Measures
Dermatology Life Quality Index
Full Information
NCT ID
NCT02031718
First Posted
January 7, 2014
Last Updated
February 26, 2015
Sponsor
University of California, Davis
1. Study Identification
Unique Protocol Identification Number
NCT02031718
Brief Title
Comparison Between Interactive Internet-based Education and Counseling for the Management of Acne With That of Internet-based Education Alone
Official Title
Comparison Between Interactive Internet-based Education and Counseling for the Management of Acne With That of Internet-based Education Alone
Study Type
Interventional
2. Study Status
Record Verification Date
February 2015
Overall Recruitment Status
Completed
Study Start Date
January 2014 (undefined)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
July 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, Davis
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study will develop and evaluate the efficacy of an Internet-based education program incorporating virtual coaching. For this study, the virtual coach will consist of online videos aimed at providing acne education and promoting behaviors that support healthy skin. The use of Web-based technologies and virtual coaching in acne-related patient education is novel, and may significantly improve clinical outcomes and quality of life in acne patients. We hypothesize that an interactive Internet-based education and counseling program will be more effective than Internet-based education alone in improving clinical outcomes and quality of life in acne patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acne Vulgaris
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
98 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Online Education
Arm Type
No Intervention
Arm Title
Online Education & Virtual Counseling
Arm Type
Experimental
Arm Description
Online virtual counseling
Intervention Type
Behavioral
Intervention Name(s)
Virtual Counseling
Primary Outcome Measure Information:
Title
Acne Lesion Counts (Inflammatory and Non-inflammatory)
Time Frame
Up to 12 weeks
Secondary Outcome Measure Information:
Title
Dermatology Life Quality Index
Time Frame
Up to 12 weeks
Other Pre-specified Outcome Measures:
Title
Knowledge
Time Frame
Up to 12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of mild to moderate acne vulgaris
13 years of age or older at time of assent, may be men or women.
Able read and understand English.
Able to hear and see the educational videos.
Access to computer with Internet access.
Capable of giving informed consent.
Not currently using any prescription acne treatment.
Exclusion Criteria:
Non-English speaking individuals.
Self-reported exposure to environmental or chemical comedogenic agents
Women with self-reported hyperandrogenism (e.g., PCOS)
Women self-reporting current use of any form of specific acne-directed hormonal therapy
Men or women with self-reported history of Cushing syndrome or congenital adrenal hyperplasia
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Audrey Wang, MD
Organizational Affiliation
University of California, Davis
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
April W Armstrong, MD, MPH
Organizational Affiliation
University of Colorado, Denver
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, Davis
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
26017816
Citation
Tuong W, Wang AS, Armstrong AW. Effect of Automated Online Counseling on Clinical Outcomes and Quality of Life Among Adolescents With Acne Vulgaris: A Randomized Clinical Trial. JAMA Dermatol. 2015 Sep;151(9):970-5. doi: 10.1001/jamadermatol.2015.0859.
Results Reference
derived
Learn more about this trial
Comparison Between Interactive Internet-based Education and Counseling for the Management of Acne With That of Internet-based Education Alone
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