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Subantimicrobial Doxycycline in Acne

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05399290
Recruitment Status : Completed
First Posted : June 1, 2022
Results First Posted : April 3, 2023
Last Update Posted : April 3, 2023
Sponsor:
Information provided by (Responsible Party):
Michelle Gallagher, Michigan State University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Acne Vulgaris Pediatrics Drug: Doxycycline Hyclate Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial Investigating the Pediatric Patient Experience of Subantimicrobial Dose Doxycycline for Acne Treatment
Actual Study Start Date : November 19, 2020
Actual Primary Completion Date : November 8, 2021
Actual Study Completion Date : November 8, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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


Other Outcome Measures:
  1. 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.

  2. Side Effects [ Time Frame: 12 weeks ]
    Any side effects associated with taking doxycycline for acne is encouraged to be discussed with the clinician


Eligibility Criteria
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Ages Eligible for Study:   13 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05399290


Locations
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United States, Michigan
Messenger Dermatology Clinic
Lansing, Michigan, United States, 48912
Sponsors and Collaborators
Michigan State University
Investigators
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Principal Investigator: Michelle Gallagher, DO Michigan State University
  Study Documents (Full-Text)

Documents provided by Michelle Gallagher, Michigan State University:
Study Protocol, Statistical Analysis Plan, and Informed Consent Form  [PDF] October 8, 2022

More Information
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Responsible Party: Michelle Gallagher, Assistant Professor, Michigan State University
ClinicalTrials.gov Identifier: NCT05399290    
Other Study ID Numbers: STUDY00003269
First Posted: June 1, 2022    Key Record Dates
Results First Posted: April 3, 2023
Last Update Posted: April 3, 2023
Last Verified: March 2023

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Michelle Gallagher, Michigan State University:
Acne Vulgaris
Doxycycline
Sub-Antimicrobial
Pediatrics
Additional relevant MeSH terms:
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Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Sebaceous Gland Diseases
Doxycycline
 Anti-Bacterial Agents
Anti-Infective Agents
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents