NCT02031718

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
98

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2014

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

January 7, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 9, 2014

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
Last Updated

February 27, 2015

Status Verified

February 1, 2015

Enrollment Period

6 months

First QC Date

January 7, 2014

Last Update Submit

February 26, 2015

Conditions

Outcome Measures

Primary Outcomes (1)

  • Acne Lesion Counts (Inflammatory and Non-inflammatory)

    Up to 12 weeks

Secondary Outcomes (1)

  • Dermatology Life Quality Index

    Up to 12 weeks

Other Outcomes (1)

  • Knowledge

    Up to 12 weeks

Study Arms (2)

Online Education

NO INTERVENTION

Online Education & Virtual Counseling

EXPERIMENTAL

Online virtual counseling

Behavioral: Virtual Counseling

Interventions

Online Education & Virtual Counseling

Eligibility Criteria

Age13 Years - 19 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Diagnosis of mild to moderate acne vulgaris
  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California, Davis

Sacramento, California, 95817, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Acne Vulgaris

Condition Hierarchy (Ancestors)

Acneiform EruptionsSkin DiseasesSkin and Connective Tissue DiseasesSebaceous Gland Diseases

Study Officials

  • Audrey Wang, MD

    University of California, Davis

    PRINCIPAL INVESTIGATOR
  • April W Armstrong, MD, MPH

    University of Colorado, Denver

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 7, 2014

First Posted

January 9, 2014

Study Start

January 1, 2014

Primary Completion

July 1, 2014

Study Completion

July 1, 2014

Last Updated

February 27, 2015

Record last verified: 2015-02

Locations