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OpenTrials
Completed

NCT Number: NCT05399290

Subantimicrobial Doxycycline in Acne

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.

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Key information

Conditions

Acne Vulgaris Acneiform Eruptions Pediatrics Sebaceous Gland Diseases Skin Diseases Skin and Connective Tissue Diseases

Age range

13 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Messenger Dermatology Clinic

Lansing, Michigan, 48912, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Doxycycline Hyclate

Drug

100 mg vs 20 mg doxycycline hyclate BID for 12 weeks

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Michigan State University

Other

Registry information

Official study title

A Randomized Controlled Trial Investigating the Pediatric Patient Experience of Subantimicrobial Dose Doxycycline for Acne Treatment

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jun 1, 2022
Registry last updated
Apr 3, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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