We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
ClinicalTrials.gov Menu

Teledermatology and Modulation of Antibiotic Dose in Acne Vulgaris

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02905851
Recruitment Status : Completed
First Posted : September 19, 2016
Last Update Posted : July 2, 2018
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.

Layout table for study information
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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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

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

Layout table for location information
United States, California
UC Davis Department of Dermatology, Clinical Trials Unit
Sacramento, California, United States, 95816
Sponsors and Collaborators
University of California, Davis
Layout table for investigator information
Principal Investigator: Raja Sivamani, MD UC Davis
Layout table for additonal information
Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT02905851    
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:
Layout table for MeSH terms
Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Sebaceous Gland Diseases