Subantimicrobial Doxycycline in Acne

Sponsor

Michigan State University (Other)

Overall Status

Completed

CT.gov ID

NCT05399290

Collaborator

(none)

Enrollment

Location

Arms

11.6

Actual Duration (Months)

1.9

Patients Per Site Per Month

Study Details

Study Description

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

Study Type:

Interventional

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 :

Nov 19, 2020

Actual Primary Completion Date :

Nov 8, 2021

Actual Study Completion Date :

Nov 8, 2021

Arms and Interventions

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

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

Primary Outcome Measures

Patient perceptions of their acne treatment [12 weeks]
Biweekly Qualtrics surveys are 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 (at baseline, every 2 weeks)

Other Outcome Measures

Changes in medication, open comments in the Qualtrics survey regarding acne treatment [12 weeks]
Participants are invited to report any medication changes and submit open-ended comments concerning their use of doxycycline or their acne experiences.
Side effects [12 weeks]
Any side effects associated with taking doxycycline for acne is encouraged to be discussed with the clinician

Eligibility Criteria

Criteria

Ages Eligible for Study:

13 Years to 17 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Locations

	Site	City	State	Country	Postal Code
1	Messenger Dermatology Clinic	Lansing	Michigan	United States	48912

Sponsors and Collaborators

Michigan State University

Investigators

Principal Investigator: Michelle Gallagher, DO, Michigan State University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Michelle Gallagher, Assistant Professor, Michigan State University

ClinicalTrials.gov Identifier:

NCT05399290

Other Study ID Numbers:

STUDY00003269

First Posted:

Jun 1, 2022

Last Update Posted:

Jun 3, 2022

Last Verified:

May 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Michelle Gallagher, Assistant Professor, Michigan State University

Additional relevant MeSH terms:

Acne Vulgaris

Doxycycline

Study Results

No Results Posted as of Jun 3, 2022