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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
Michigan State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acne Vulgaris focused on measuring Acne Vulgaris, Doxycycline, Sub-Antimicrobial, Pediatrics

Eligibility Criteria

13 Years - 17 Years (Child)All SexesAccepts Healthy Volunteers

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

First Posted
May 26, 2022
Last Updated
March 7, 2023
Sponsor
Michigan State University
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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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