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Teledermatology and Modulation of Antibiotic Dose in Acne Vulgaris

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ClinicalTrials.gov Identifier: NCT02905851
Recruitment Status : Completed
First Posted : September 19, 2016
Last Update Posted : July 2, 2018
Sponsor:
Information provided by (Responsible Party):
University of California, Davis

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

Condition or disease Intervention/treatment Phase
Acne Vulgaris Other: Feedback group Other: Non Feedback group Not Applicable

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:

  1. Feedback group
  2. 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  (Clinical Trial)
Actual Enrollment : 4 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Teledermatology and Modulation of Antibiotic Dose in Acne Vulgaris
Study Start Date : May 2016
Actual Primary Completion Date : May 2018
Actual Study Completion Date : May 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne Antibiotics

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.
Other: Non Feedback group
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:

  1. Continue current dose
  2. 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.
  3. Increase dose if had been previously reduced, dose will not be increased beyond the initial starting dose.
Other: Feedback group
Monitoring ability to use teledermatology to modify antibiotic burden




Primary Outcome Measures :
  1. 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


Other Outcome Measures:
  1. Change in acne grading (change in patient grading) [ Time Frame: Assessed at 4, 8, 12 weeks ]
    Change in Patient Grading

  2. Change in acne grading (investigator global assessment) [ Time Frame: Assessed at 4, 8, 12 weeks ]
    Change in Investigator Global Assessment

  3. Change in acne grading (lesion counting) [ Time Frame: Assessed at 4, 8, 12 weeks ]
    Change in Lesion Counting

  4. Change in acne grading using the global acne grading [ Time Frame: Assessed at 4, 8, 12 weeks ]
    Change in Global Acne Grading



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Ages Eligible for Study:   15 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02905851


Locations
United States, California
UC Davis Department of Dermatology, Clinical Trials Unit
Sacramento, California, United States, 95816
Sponsors and Collaborators
University of California, Davis
Investigators
Principal Investigator: Raja Sivamani, MD UC Davis

Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT02905851     History of Changes
Other Study ID Numbers: 869597
First Posted: September 19, 2016    Key Record Dates
Last Update Posted: July 2, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Sebaceous Gland Diseases
Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents