Acne VulgarisNCT00417456
The Development and Evaluation of an "E-Visit" Program for the Management of Acne
A study testing Evisit and Office visit in people with Acne Vulgaris, run by Massachusetts General Hospital at 2 sites in United States.
Trial summary
The purpose of this study is to test the efficacy, timeliness, and user satisfaction of an online "E-Visit" application that uses store-and-forward technology for acne patients requiring dermatologic care for their condition. Hypotheses: 1. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Acne Vulgaris
- What is being tested?
- Evisit and Office visit
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 151 participants
- Where
- 2 sitesUnited States
- Study dates
- Oct 2005to Dec 2007
- 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age 12 or older
- Diagnosis of mild to severe facial acne
- Access to a credit card
- Access to an Internet connection and a computer
- Ability to image self
- MA Blue Cross/ Blue Shield Coverage
Who cannot join
- Non-English speaking individuals
- Patients taking Accutane for their acne
- Impaired Physical ability to image self
- Impaired Cognitive ability
Trial locations and contacts
2 sites in 1 country.
United States2 sites
MGH Dermatology Associates
Boston, Massachusetts, 02114
Brigham and Women's Hospital Department of Dermatology
Boston, Massachusetts, 02115
About this study
The purpose of this study is to test the efficacy, timeliness, and user satisfaction of an online "E-Visit" application that uses store-and-forward technology for acne patients requiring dermatologic care for their condition. Hypotheses:
- That an "E-Visit" is an effective alternative to in-person clinic care for patients with mild to severe facial acne.
- That providers and patients will be satisfied with this model.
- That mean wait times for new and return visits will be reduced through the "E-Visit" model.
- That this prototype for care will improve clinic workflow, offer additional patient access, and allow urgent cases to be seen earlier.
Read the detailed description
Across the United States, a geographically mal-distributed workforce of Dermatologists exists, a problem that is projected to worsen. Patient access to dermatologic care is threatened. The dermatology workforce shortage has resulted in long wait times for patients, especially new patient visits and acute care cases.
Teledermatology has received much attention as a solution to the preceding problems. Teledermatology can reduce the burden of repeat office visits in chronic conditions by facilitating care from home. In this trial, a model incorporating store-and-forward technology is tested in general clinics while its impact on clinical outcomes, satisfaction, and wait times are studied.
Comparison: After consent, study subjects are assigned a unique study number and randomly assigned to one of two groups:
Group 1- The first group of subjects will have four (4) in-office visits spaced six weeks apart.
Group 2- The second group will have four (4) "e-visits" spaced six weeks apart.
At the end of study (after completion of 5th visit overall) all participants will complete a satisfaction survey.
- Conditions
- Acne Vulgaris
- Being tested
- Evisit, Office visit
- Keywords
- Acne, Telemedicine, Dermatology
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EvisitOther
Also called RelayHealth platform
Asynchronous,remote care delivery via a secure web platform
Office visitOther
Conventional office-based care
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Office Visits Receives: Other: Office visit |
| 2 | Experimental | Evisit Receives: Other: Evisit |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peer review of subject images using the Total Inflammatory Lesion Count at the end of active recruitment
Measured: 6 months
Secondary outcomes (3)
Subject satisfaction
Measured: 6 months
Physician satisfaction
Measured: 6 months
Timing of visits
Measured: ongoing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2007 (estimated)
- Study startOct 2005
- Primary completionDec 2007
- Study completionDec 2007
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 Massachusetts General HospitalThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 151 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joseph C. Kvedar, Massachusetts General Hospital
- Investigators
- Joseph C. Kvedar, M.D., Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00417456
- Sponsor's protocol ID
- 2005-P-000289
- Status last verified
- Mar 2012
- First submitted
- 29 Dec 2006
- Last updated
- 16 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Watson AJ, Bergman H, Williams CM, Kvedar JC. A randomized trial to evaluate the efficacy of online follow-up visits in the management of acne. Arch Dermatol. 2010 Apr;146(4):406-11. doi: 10.1001/archdermatol.2010.29.
PubMed 20404229
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Development and Evaluation of an "E-Visit" Program for the Management of Acne
- ClinicalTrials.gov ID
- NCT00417456
- Acronym / sponsor ID
- 2005-P-000289
- Conditions
- Acne Vulgaris
- Keywords
- Acne, Telemedicine, Dermatology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 151 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Oct 2005
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 1 Jan 2007 (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.
The purpose of this study is to test the efficacy, timeliness, and user satisfaction of an online "E-Visit" application that uses store-and-forward technology for acne patients requiring dermatologic care for their condition. Hypotheses:
- That an "E-Visit" is an effective alternative to in-person clinic care for patients with mild to severe facial acne.
- That providers and patients will be satisfied with this model.
- That mean wait times for new and return visits will be reduced through the "E-Visit" model.
- That this prototype for care will improve clinic workflow, offer additional patient access, and allow urgent cases to be seen earlier.
Detailed description
Across the United States, a geographically mal-distributed workforce of Dermatologists exists, a problem that is projected to worsen. Patient access to dermatologic care is threatened. The dermatology workforce shortage has resulted in long wait times for patients, especially new patient visits and acute care cases.
Teledermatology has received much attention as a solution to the preceding problems. Teledermatology can reduce the burden of repeat office visits in chronic conditions by facilitating care from home. In this trial, a model incorporating store-and-forward technology is tested in general clinics while its impact on clinical outcomes, satisfaction, and wait times are studied.
Comparison: After consent, study subjects are assigned a unique study number and randomly assigned to one of two groups:
Group 1- The first group of subjects will have four (4) in-office visits spaced six weeks apart.
Group 2- The second group will have four (4) "e-visits" spaced six weeks apart.
At the end of study (after completion of 5th visit overall) all participants will complete a satisfaction survey.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Other: Office visitOffice Visits |
| 2 | Experimental | Other: EvisitEvisit |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Age 12 or older
- Diagnosis of mild to severe facial acne
- Access to a credit card
- Access to an Internet connection and a computer
- Ability to image self
Key exclusion criteria (4 listed)
- Non-English speaking individuals
- Patients taking Accutane for their acne
- Impaired Physical ability to image self
- Impaired Cognitive ability
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 |
|---|---|---|
| EvisitAlso: RelayHealth platformAsynchronous,remote care delivery via a secure web platform | Other | 2 |
| Office visitConventional office-based care | Other | 1 |
Primary outcome
Peer review of subject images using the Total Inflammatory Lesion Count at the end of active recruitment
Time frame: 6 months
3 secondary outcomes
Subject satisfaction
Time frame: 6 months
Physician satisfaction
Time frame: 6 months
Timing of visits
Time frame: ongoing
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 16 Mar 2012.
- Derived from this study: PubMed 20404229Watson AJ, Bergman H, Williams CM, Kvedar JC. A randomized trial to evaluate the efficacy of online follow-up visits in the management of acne. Arch Dermatol. 2010 Apr;146(4):406-11. doi: 10.1001/archdermatol.2010.29.
Related trials for Acne Vulgaris
RecruitingObservational study
Collection of Samples From Subjects With Various Skin Conditions and Healthy Volunteers
Acne, Atopic Dermatitis
RecruitingPhase 3
Study of New Antiandrogenic Progestogen + Low-dose Estrogen for Moderate Acne Vulgaris
Acne Vulgaris, Acne Vulgaris on the Face
Not yet recruiting
A Single-Center, Open-Label Study to Assess the Efficacy and Tolerability of a Brightening Serum in Skin of Color Patients With Post Inflammatory Hyperpigmentation
Post-inflammatory Hyperpigmentation, Post-acne Hyperpigmentation
RecruitingPhase 3
Phase 3 Study of Denifanstat in Participants With Moderate to Severe Acne (AURORA)
Acne Vulgaris
Recruiting
Comparison of Topical Clascoterone 1% Cream Versus Adapalene 0.1% Cream in the Treatment of Mild-to-Moderate Acne Vulgaris
Acne Vulgaris
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.
Joseph C. Kvedar, M.D. principal investigator
Massachusetts General Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Evisit and Office visit in people with Acne Vulgaris, run by Massachusetts General Hospital at 2 sites 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 6 inclusion and 4 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 16 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Peer review of subject images using the Total Inflammatory Lesion Count at the end of active recruitment (time frame: 6 months). 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 NCT00417456, 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 16 Mar 2012.