Subantimicrobial Doxycycline in Acne

March 7, 2023 updated by: Michelle Gallagher, Michigan State University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

22

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Lansing, Michigan, United States, 48912
        • Messenger Dermatology Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

13 years to 17 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 100 mg standard dose doxycycline BID
Oral, 12 weeks
Drug: Doxycycline Hyclate
100 mg vs 20 mg doxycycline hyclate BID for 12 weeks
Experimental: 20 mg sub-antimicrobial dose doxycycline BID
Oral, 12 weeks
Drug: Doxycycline Hyclate
100 mg vs 20 mg doxycycline hyclate BID for 12 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
12 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in Medication, Open Comments in the Qualtrics Survey Regarding Acne Treatment
Time Frame: 12 weeks
Participants are invited to report any medication changes and submit open-ended comments concerning their use of doxycycline or their acne experiences.
12 weeks
Side Effects
Time Frame: 12 weeks
Any side effects associated with taking doxycycline for acne is encouraged to be discussed with the clinician
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Michigan State University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 19, 2020

Primary Completion (Actual)

November 8, 2021

Study Completion (Actual)

November 8, 2021

Study Registration Dates

First Submitted

May 26, 2022

First Submitted That Met QC Criteria

May 26, 2022

First Posted (Actual)

June 1, 2022

Study Record Updates

Last Update Posted (Actual)

April 3, 2023

Last Update Submitted That Met QC Criteria

March 7, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00003269

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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