Subantimicrobial Doxycycline in Acne
Primary Purpose
Acne Vulgaris, Pediatrics
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Doxycycline Hyclate
Sponsored by
About this trial
This is an interventional treatment trial for Acne Vulgaris focused on measuring Acne Vulgaris, Doxycycline, Sub-Antimicrobial, Pediatrics
Eligibility Criteria
Inclusion Criteria:
- Documented moderate to severe facial acne
Exclusion Criteria:
- 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
Sites / Locations
- Messenger Dermatology Clinic
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
100 mg standard dose doxycycline BID
20 mg sub-antimicrobial dose doxycycline BID
Arm Description
Oral, 12 weeks
Oral, 12 weeks
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05399290
Brief Title
Subantimicrobial Doxycycline in Acne
Official Title
A Randomized Controlled Trial Investigating the Pediatric Patient Experience of Subantimicrobial Dose Doxycycline for Acne Treatment
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
November 19, 2020 (Actual)
Primary Completion Date
November 8, 2021 (Actual)
Study Completion Date
November 8, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Michigan State University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acne Vulgaris, Pediatrics
Keywords
Acne Vulgaris, Doxycycline, Sub-Antimicrobial, Pediatrics
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
100 mg standard dose doxycycline BID
Arm Type
Active Comparator
Arm Description
Oral, 12 weeks
Arm Title
20 mg sub-antimicrobial dose doxycycline BID
Arm Type
Experimental
Arm Description
Oral, 12 weeks
Intervention Type
Drug
Intervention Name(s)
Doxycycline Hyclate
Intervention Description
100 mg vs 20 mg doxycycline hyclate BID for 12 weeks
Primary Outcome Measure Information:
Title
Patient Perceptions of Their Acne Treatment
Description
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
Time Frame
12 weeks
Other Pre-specified Outcome Measures:
Title
Changes in Medication, Open Comments in the Qualtrics Survey Regarding Acne Treatment
Description
Participants are invited to report any medication changes and submit open-ended comments concerning their use of doxycycline or their acne experiences.
Time Frame
12 weeks
Title
Side Effects
Description
Any side effects associated with taking doxycycline for acne is encouraged to be discussed with the clinician
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Documented moderate to severe facial acne
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michelle Gallagher, DO
Organizational Affiliation
Michigan State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Messenger Dermatology Clinic
City
Lansing
State/Province
Michigan
ZIP/Postal Code
48912
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Subantimicrobial Doxycycline in Acne
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