Teledermatology and Modulation of Antibiotic Dose in Acne Vulgaris

NCT02905851 | Completed

• 1 other identifier: 869597
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Acne Vulgaris

Outcome Measures

Primary Outcomes (1)

• Reduced antibiotic use

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

  Assessed at 4, 8, 12 weeks

Other Outcomes (4)

• Change in acne grading (change in patient grading)

  Assessed at 4, 8, 12 weeks

• Change in acne grading (investigator global assessment)

  Assessed at 4, 8, 12 weeks

• Change in acne grading (lesion counting)

  Assessed at 4, 8, 12 weeks

Study Arms (2)

Non Feedback

PLACEBO COMPARATOR

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

Feedback group

ACTIVE COMPARATOR

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

Interventions

Feedback group OTHER

Monitoring ability to use teledermatology to modify antibiotic burden

Feedback group

Non Feedback group OTHER

To use as control to see if antibiotic burden has been reduced in the active feedback group

Non Feedback

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, Davis: lead

Study Sites (1)

UC Davis Department of Dermatology, Clinical Trials Unit

Sacramento, California, 95816, United States

Location

MeSH Terms

Conditions

Acne Vulgaris

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases

Study Officials

• Raja Sivamani, MD

  UC Davis

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2016
• First Posted: September 19, 2016
• Study Start: May 1, 2016
• Primary Completion: May 1, 2018
• Study Completion: May 1, 2018
• Last Updated: July 2, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)