Subantimicrobial Doxycycline in Acne

Phase 4

Completed

• Conditions: Acne Vulgaris; Pediatrics
• Interventions: Drug: Doxycycline Hyclate

• Registration Number: NCT05399290
• Lead Sponsor: Michigan State University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-11-19
• Primary Completion: 2021-11-08
• Study Completion: 2021-11-08
• Study First Submitted: 2022-05-26
• Study First Submitted QC: 2022-05-26
• Study First Posted: 2022-06-01
• Results First Submitted: 2022-10-26
• Status Verified: 2023-03
• Results First Submitted QC: 2023-03-07
• Last Update Submitted: 2023-03-07
• Results First Posted: 2023-04-03
• Last Update Posted: 2023-04-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
100 mg standard dose doxycycline BID	Doxycycline Hyclate	Oral, 12 weeks
20 mg sub-antimicrobial dose doxycycline BID	Doxycycline Hyclate	Oral, 12 weeks

Primary Outcome Measures

Name	Time	Method
Patient Perceptions of Their Acne Treatment	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

Trial Locations

Locations (1)

Messenger Dermatology Clinic; 🇺🇸 Lansing, Michigan, United States