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Teledermatology and Modulation of Antibiotic Dose in Acne Vulgaris

Primary Purpose

Acne Vulgaris

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Feedback group
Non Feedback group
Sponsored by
University of California, Davis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acne Vulgaris

Eligibility Criteria

15 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • UC Davis Department of Dermatology, Clinical Trials Unit

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Non Feedback

Feedback group

Arm Description

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.

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: Continue current dose Reduce dose if there is at least a one point improvement in both the investigator acne global assessment AND the patient acne global assessment scores: A dose reduction will be such that the dose is halved from the previous dose. For example if the subject is on minocycline or doxycycline 100 mg twice daily, they will be reduced to minocycline or doxycycline 100 mg daily. Increase dose if had been previously reduced, dose will not be increased beyond the initial starting dose.

Outcomes

Primary Outcome Measures

Reduced antibiotic use
The difference in antibiotic exposure in the physician feedback group compared to those not receiving feedback

Secondary Outcome Measures

Full Information

First Posted
June 9, 2016
Last Updated
June 28, 2018
Sponsor
University of California, Davis
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1. Study Identification

Unique Protocol Identification Number
NCT02905851
Brief Title
Teledermatology and Modulation of Antibiotic Dose in Acne Vulgaris
Official Title
Teledermatology and Modulation of Antibiotic Dose in Acne Vulgaris
Study Type
Interventional

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
May 2016 (undefined)
Primary Completion Date
May 2018 (Actual)
Study Completion Date
May 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, Davis

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
To see if teledermatology can be used to reduce antibiotic burden in patients on doxycycline or minocycline for acne vulgaris
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acne Vulgaris

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
4 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Non Feedback
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
Feedback group
Arm Type
Active Comparator
Arm Description
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: Continue current dose Reduce dose if there is at least a one point improvement in both the investigator acne global assessment AND the patient acne global assessment scores: A dose reduction will be such that the dose is halved from the previous dose. For example if the subject is on minocycline or doxycycline 100 mg twice daily, they will be reduced to minocycline or doxycycline 100 mg daily. Increase dose if had been previously reduced, dose will not be increased beyond the initial starting dose.
Intervention Type
Other
Intervention Name(s)
Feedback group
Intervention Description
Monitoring ability to use teledermatology to modify antibiotic burden
Intervention Type
Other
Intervention Name(s)
Non Feedback group
Intervention Description
To use as control to see if antibiotic burden has been reduced in the active feedback group
Primary Outcome Measure Information:
Title
Reduced antibiotic use
Description
The difference in antibiotic exposure in the physician feedback group compared to those not receiving feedback
Time Frame
Assessed at 4, 8, 12 weeks
Other Pre-specified Outcome Measures:
Title
Change in acne grading (change in patient grading)
Description
Change in Patient Grading
Time Frame
Assessed at 4, 8, 12 weeks
Title
Change in acne grading (investigator global assessment)
Description
Change in Investigator Global Assessment
Time Frame
Assessed at 4, 8, 12 weeks
Title
Change in acne grading (lesion counting)
Description
Change in Lesion Counting
Time Frame
Assessed at 4, 8, 12 weeks
Title
Change in acne grading using the global acne grading
Description
Change in Global Acne Grading
Time Frame
Assessed at 4, 8, 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Raja Sivamani, MD
Organizational Affiliation
UC Davis
Official's Role
Principal Investigator
Facility Information:
Facility Name
UC Davis Department of Dermatology, Clinical Trials Unit
City
Sacramento
State/Province
California
ZIP/Postal Code
95816
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Teledermatology and Modulation of Antibiotic Dose in Acne Vulgaris

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