Teledermatology and Modulation of Antibiotic Dose in Acne Vulgaris

NCT ID: NCT02905851

Last Updated: 2018-07-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

4 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-31

Study Completion Date

2018-05-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Acne Vulgaris

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type PLACEBO_COMPARATOR

Non Feedback group

Intervention Type OTHER

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

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.

Group Type ACTIVE_COMPARATOR

Feedback group

Intervention Type OTHER

Monitoring ability to use teledermatology to modify antibiotic burden

Interventions

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Feedback group

Monitoring ability to use teledermatology to modify antibiotic burden

Intervention Type OTHER

Non Feedback group

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of California, Davis

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Raja Sivamani, MD

Role: PRINCIPAL_INVESTIGATOR

UC Davis

Locations

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UC Davis Department of Dermatology, Clinical Trials Unit

Sacramento, California, United States

Site Status

Countries

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United States

Other Identifiers

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869597

Identifier Type: -

Identifier Source: org_study_id

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