Acne VulgarisPhase 4NCT05399290
Subantimicrobial Doxycycline in Acne
A Phase 4 study testing Doxycycline Hyclate in people with Acne Vulgaris and Pediatrics, run by Michigan State University at 1 site in United States.
Trial summary
Antibiotic resistance is a public health problem that worsens the more physicians prescribe standard dose antibiotics for acne. Regardless of race, acne vulgaris is one of the most common dermatologic conditions among pediatric populations. Read more about this study
- Who is it for?
- Ages 13 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Acne Vulgaris, Pediatrics
- What is being tested?
- Doxycycline Hyclate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Nov 2020to 8 Nov 2021
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 13 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Documented moderate to severe facial acne
Who cannot join
- Other skin conditions on the face
- Previous antibiotic treatment for acne
- Use of antibiotics for any reason within the past month
- Use of new prescription regiment for acne within the last 3 months
- Positive pregnancy test in the clinic
- Cognitive impairments
Trial locations and contacts
1 site in 1 country.
United States1 site
Messenger Dermatology Clinic
Lansing, Michigan, 48912
About this study
Official title: A Randomized Controlled Trial Investigating the Pediatric Patient Experience of Subantimicrobial Dose Doxycycline for Acne Treatment
Antibiotic resistance is a public health problem that worsens the more physicians prescribe standard dose antibiotics for acne. Regardless of race, acne vulgaris is one of the most common dermatologic conditions among pediatric populations. As such, clinicians can make a large impact by practicing good antibiotic stewardship while still addressing the impact of acne on adolescents' self-esteem. Subantimicrobial doxycycline maintains its anti-inflammatory effects while eliminating antimicrobial properties and associated risks of drug resistance. Few studies, focused primarily on adults, have shown that subantimicrobial doxycycline is efficacious in treating acne from a physician standpoint. The investigators aim to investigate the patient experience of acne treatment with subantimicrobial dose doxycycline in the pediatric population.
- Conditions
- Acne Vulgaris, Pediatrics
- Being tested
- Doxycycline Hyclate
- Keywords
- Acne Vulgaris, Doxycycline, Sub-Antimicrobial, Pediatrics
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Doxycycline HyclateDrug
100 mg vs 20 mg doxycycline hyclate BID for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| 100 mg standard dose doxycycline BID | Active comparator | Oral, 12 weeks Receives: Drug: Doxycycline Hyclate |
| 20 mg sub-antimicrobial dose doxycycline BID | Experimental | Oral, 12 weeks Receives: Drug: Doxycycline Hyclate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Perceptions of Their Acne Treatment
Biweekly Qualtrics surveys were administered to identify changes in the self-reported severity of facial acne lesions using a 10-point ordinal Likert-type scale at 7 post-prescription time point (week 0, week 2, week 4, week 6, week 8, week 10, week 12). The minimum value is 1 and the maximum value is 10, with increasing acne severity (i.e. 10 is most severe acne).
- In the table below, participants are labelled by a letter (A, B, etc.) to differentiate the different time points (rows) but participants in each treatment group (100 mg vs 20 mg) are different and not related.
- Data is missing for timepoints when surveys were not submitted
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2022
- Study start19 Nov 2020
- Primary completion8 Nov 2021
- Study completion8 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Acne VulgarisStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Michigan State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michelle Gallagher, Michigan State University
- Investigators
- Michelle Gallagher, DO, Principal investigator, Michigan State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05399290
- Sponsor's protocol ID
- STUDY00003269
- Status last verified
- Mar 2023
- First submitted
- 26 May 2022
- Last updated
- 3 Apr 2023
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial Investigating the Pediatric Patient Experience of Subantimicrobial Dose Doxycycline for Acne Treatment
- ClinicalTrials.gov ID
- NCT05399290
- Acronym / sponsor ID
- STUDY00003269
- Conditions
- Acne Vulgaris, Pediatrics
- Keywords
- Acne Vulgaris, Doxycycline, Sub-Antimicrobial, Pediatrics
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Michigan State UniversityUniversity, hospital or other
- Study start
- 19 Nov 2020 (actual)
- Primary completion
- 8 Nov 2021 (actual)
- Study completion
- 8 Nov 2021 (actual)
- First posted
- 1 Jun 2022 (actual)
- Results
- Posted 3 Apr 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Antibiotic resistance is a public health problem that worsens the more physicians prescribe standard dose antibiotics for acne. Regardless of race, acne vulgaris is one of the most common dermatologic conditions among pediatric populations. As such, clinicians can make a large impact by practicing good antibiotic stewardship while still addressing the impact of acne on adolescents' self-esteem. Subantimicrobial doxycycline maintains its anti-inflammatory effects while eliminating antimicrobial properties and associated risks of drug resistance. Few studies, focused primarily on adults, have shown that subantimicrobial doxycycline is efficacious in treating acne from a physician standpoint. The investigators aim to investigate the patient experience of acne treatment with subantimicrobial dose doxycycline in the pediatric population.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 100 mg standard dose doxycycline BID | Active comparator | Drug: Doxycycline HyclateOral, 12 weeks |
| 20 mg sub-antimicrobial dose doxycycline BID | Experimental | Drug: Doxycycline HyclateOral, 12 weeks |
Who may qualify
- Ages
- 13 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Documented moderate to severe facial acne
Key exclusion criteria (6 listed)
- Other skin conditions on the face
- Previous antibiotic treatment for acne
- Use of antibiotics for any reason within the past month
- Use of new prescription regiment for acne within the last 3 months
- Positive pregnancy test in the clinic
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 |
|---|---|---|
| Doxycycline Hyclate100 mg vs 20 mg doxycycline hyclate BID for 12 weeks | Drug | 100 mg standard dose doxycycline BID, 20 mg sub-antimicrobial dose doxycycline BID |
Primary outcome
Patient Perceptions of Their Acne Treatment
Time frame: 12 weeks
Biweekly Qualtrics surveys were administered to identify changes in the self-reported severity of facial acne lesions using a 10-point ordinal Likert-type scale at 7 post-prescription time point (week 0, week 2, week 4, week 6, week 8, week 10, week 12). The minimum value is 1 and the maximum value is 10, with increasing acne severity (i.e. 10 is most severe acne). * In the table below, participants are labelled by a letter (A, B, etc.) to differentiate the different time points (rows) but participants in each treatment group (100 mg vs 20 mg) are different and not related. * Data is missing for timepoints when surveys were not submitted
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Michelle Gallagher, DO principal investigator
Michigan State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Doxycycline Hyclate in people with Acne Vulgaris and Pediatrics, run by Michigan State University 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 1 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 3 Apr 2023. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Apr 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Patient Perceptions of Their Acne Treatment (time frame: 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 3 Apr 2023.