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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02031718
Other study ID # 511572
Secondary ID
Status Completed
Phase N/A
First received January 7, 2014
Last updated February 26, 2015
Start date January 2014
Est. completion date July 2014

Study information

Verified date February 2015
Source University of California, Davis
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 98
Est. completion date July 2014
Est. primary completion date July 2014
Accepts healthy volunteers No
Gender Both
Age group 13 Years to 19 Years
Eligibility 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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Behavioral:
Virtual Counseling


Locations

Country Name City State
United States University of California, Davis Sacramento California

Sponsors (1)

Lead Sponsor Collaborator
University of California, Davis

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Knowledge Up to 12 weeks No
Primary Acne Lesion Counts (Inflammatory and Non-inflammatory) Up to 12 weeks No
Secondary Dermatology Life Quality Index Up to 12 weeks No
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