Acne VulgarisNCT02031718
Comparison Between Interactive Internet-based Education and Counseling for the Management of Acne With That of Internet-based Education Alone
A study testing Virtual Counseling in people with Acne Vulgaris, run by University of California, Davis at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 13 to 19 years
- Conditions the study is for
- Acne Vulgaris
- What is being tested?
- Virtual Counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2014to Jul 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, Davis
Sacramento, California, 95817
About this study
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.
- Conditions
- Acne Vulgaris
- Being tested
- Virtual Counseling
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual CounselingBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Online Education | No intervention | Not described |
| Online Education & Virtual Counseling | Experimental | Online virtual counseling Receives: Behavioral: Virtual Counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acne Lesion Counts (Inflammatory and Non-inflammatory)
Measured: Up to 12 weeks
Secondary outcomes (1)
Dermatology Life Quality Index
Measured: Up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2014 (estimated)
- Study startJan 2014
- Primary completionJul 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acne VulgarisStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Audrey Wang, MD, Principal investigator, University of California, DavisApril W Armstrong, MD, MPH, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02031718
- Sponsor's protocol ID
- 511572
- Status last verified
- Feb 2015
- First submitted
- 7 Jan 2014
- Last updated
- 27 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 26017816
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Interactive Internet-based Education and Counseling for the Management of Acne With That of Internet-based Education Alone
- ClinicalTrials.gov ID
- NCT02031718
- Acronym / sponsor ID
- 511572
- Conditions
- Acne Vulgaris
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 9 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Online Education | No intervention | – |
| Online Education & Virtual Counseling | Experimental | Behavioral: Virtual CounselingOnline virtual counseling |
Who may qualify
- Ages
- 13 to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual Counseling | Behavioural | Online Education & Virtual Counseling |
Primary outcome
Acne Lesion Counts (Inflammatory and Non-inflammatory)
Time frame: Up to 12 weeks
1 secondary outcome
Dermatology Life Quality Index
Time frame: Up to 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2015.
- Derived from this study: PubMed 26017816Tuong 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Audrey Wang, MD principal investigator
University of California, Davis
April W Armstrong, MD, MPH principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Counseling in people with Acne Vulgaris, run by University of California, Davis at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acne Lesion Counts (Inflammatory and Non-inflammatory) (time frame: Up to 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02031718, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2015.