Teledermatology and Modulation of Antibiotic Dose in Acne Vulgaris
June 28, 2018 updated by: University of California, Davis
To see if teledermatology can be used to reduce antibiotic burden in patients on doxycycline or minocycline for acne vulgaris
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The investigators are going to ascertain if antibiotic burden can be reduced with tele dermatology use.
There are two arms of the study:
- Feedback group
- Non feedback group
All subjects will be randomised to either group, all subjects will take photos of their face and answer questions at baseline, visit 2 (1 month), visit 3 (2 months), visit 4 (3 months).
The investigators will then use measurements of acne grading (patient grading, investigator global assessment, lesion counting, global acne grading) to reduce/taper antibiotics in the feedback group.
Study Type
Interventional
Enrollment (Actual)
4
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
Sacramento, California, United States, 95816
- UC Davis Department of Dermatology, Clinical Trials Unit
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
15 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Subjects aged 15 years and older
- Subjects who have been prescribed doxycycline or minocycline by their physician for acne vulgaris but have not initiated treatment yet.
Exclusion Criteria:
- Subjects who have used isotretinoin in the last 6 weeks
- Those who have used oral antibiotics within the last 4 weeks
- Those who have been initiated or changed brand of oral contraceptive pill within the last one month.
- Those subjects who cannot engage with the teledermatology platform
- Prisoners
- Adults unable to consent
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Placebo Comparator: Non Feedback
No feedback given to this group regarding their antibiotic use Subjects take images and answer questions during the study like the feedback group, but in this group no feedback re dosing is given.
|
To use as control to see if antibiotic burden has been reduced in the active feedback group
|
|
Active Comparator: Feedback group
Feedback given to this group regarding their antibiotic use after baseline. If the subject is in the feedback group, after this visit, a dermatologist will review all images and the survey results and give the patient information about whether they should:
|
Monitoring ability to use teledermatology to modify antibiotic burden
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Reduced antibiotic use
Time Frame: Assessed at 4, 8, 12 weeks
|
The difference in antibiotic exposure in the physician feedback group compared to those not receiving feedback
|
Assessed at 4, 8, 12 weeks
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in acne grading (change in patient grading)
Time Frame: Assessed at 4, 8, 12 weeks
|
Change in Patient Grading
|
Assessed at 4, 8, 12 weeks
|
|
Change in acne grading (investigator global assessment)
Time Frame: Assessed at 4, 8, 12 weeks
|
Change in Investigator Global Assessment
|
Assessed at 4, 8, 12 weeks
|
|
Change in acne grading (lesion counting)
Time Frame: Assessed at 4, 8, 12 weeks
|
Change in Lesion Counting
|
Assessed at 4, 8, 12 weeks
|
|
Change in acne grading using the global acne grading
Time Frame: Assessed at 4, 8, 12 weeks
|
Change in Global Acne Grading
|
Assessed at 4, 8, 12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Raja Sivamani, MD, UC Davis
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2016
Primary Completion (Actual)
May 1, 2018
Study Completion (Actual)
May 1, 2018
Study Registration Dates
First Submitted
June 9, 2016
First Submitted That Met QC Criteria
September 13, 2016
First Posted (Estimate)
September 19, 2016
Study Record Updates
Last Update Posted (Actual)
July 2, 2018
Last Update Submitted That Met QC Criteria
June 28, 2018
Last Verified
June 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 869597
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.