Subantimicrobial Doxycycline in Acne

Acne Vulgaris Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05399290
• Other study ID #: STUDY00003269
• Status: Completed
• Phase: Phase 4
• Start date: November 19, 2020
• Est. completion date: November 8, 2021

Study information

• Verified date: March 2023
• Source: Michigan State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: November 8, 2021
• Est. primary completion date: November 8, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 13 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Acne Vulgaris
• Pediatrics

Intervention

Drug:
• Doxycycline Hyclate
100 mg vs 20 mg doxycycline hyclate BID for 12 weeks

Locations

Country	Name	City	State
United States	Messenger Dermatology Clinic	Lansing	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Michigan State University

Country where clinical trial is conducted

United States, 

Outcome

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