Acne VulgarisNCT02905851
Teledermatology and Modulation of Antibiotic Dose in Acne Vulgaris
A study testing Feedback group and Non Feedback group in people with Acne Vulgaris, run by University of California, Davis at 1 site in United States.
Trial summary
To see if teledermatology can be used to reduce antibiotic burden in patients on doxycycline or minocycline for acne vulgaris Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Acne Vulgaris
- What is being tested?
- Feedback group and Non Feedback group
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- May 2016to May 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
UC Davis Department of Dermatology, Clinical Trials Unit
Sacramento, California, 95816
About this study
To see if teledermatology can be used to reduce antibiotic burden in patients on doxycycline or minocycline for acne vulgaris
Read the 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.
- Conditions
- Acne Vulgaris
- Being tested
- Feedback group, Non Feedback group
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Feedback groupOther
Monitoring ability to use teledermatology to modify antibiotic burden
Non Feedback groupOther
To use as control to see if antibiotic burden has been reduced in the active feedback group
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Feedback group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduced antibiotic use
The difference in antibiotic exposure in the physician feedback group compared to those not receiving feedback
Measured: Assessed at 4, 8, 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2016 (estimated)
- Study startMay 2016
- Primary completionMay 2018
- Study completionMay 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acne VulgarisStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Raja Sivamani, MD, Principal investigator, UC Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02905851
- Sponsor's protocol ID
- 869597
- Status last verified
- Jun 2018
- First submitted
- 9 Jun 2016
- Last updated
- 2 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Teledermatology and Modulation of Antibiotic Dose in Acne Vulgaris
- ClinicalTrials.gov ID
- NCT02905851
- Acronym / sponsor ID
- 869597
- Conditions
- Acne Vulgaris
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Study start
- May 2016
- Primary completion
- May 2018 (actual)
- Study completion
- May 2018 (actual)
- First posted
- 19 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non Feedback | Placebo comparator | Other: Non Feedback groupNo 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 group | Active comparator | Other: Feedback groupFeedback 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. |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Feedback groupMonitoring ability to use teledermatology to modify antibiotic burden | Other | Feedback group |
| Non Feedback groupTo use as control to see if antibiotic burden has been reduced in the active feedback group | Other | Non Feedback |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Raja Sivamani, MD principal investigator
UC Davis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Feedback group and Non Feedback group in people with Acne Vulgaris, run by University of California, Davis at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduced antibiotic use (time frame: Assessed at 4, 8, 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2018.