Subantimicrobial Doxycycline in Acne

Study Overview
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Brief Summary
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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.

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

Conditions
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Acne Vulgaris, Pediatrics

Intervention / Treatment
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* Drug: Doxycycline Hyclate


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 13 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acne Vulgaris, Doxycycline, Sub-Antimicrobial, Pediatrics