NCT05399290

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Nov 2020

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 19, 2020

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 8, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 8, 2021

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

May 26, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 1, 2022

Completed
10 months until next milestone

Results Posted

Study results publicly available

April 3, 2023

Completed
Last Updated

April 3, 2023

Status Verified

March 1, 2023

Enrollment Period

12 months

First QC Date

May 26, 2022

Results QC Date

October 26, 2022

Last Update Submit

March 7, 2023

Conditions

Acne VulgarisPediatrics

Keywords

Acne VulgarisDoxycyclineSub-AntimicrobialPediatrics

Outcome Measures

Primary Outcomes (1)

  • 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

Other Outcomes (2)

  • Changes in Medication, Open Comments in the Qualtrics Survey Regarding Acne Treatment

    12 weeks

  • Side Effects

    12 weeks

Study Arms (2)

100 mg standard dose doxycycline BID

ACTIVE COMPARATOR

Oral, 12 weeks

Drug: Doxycycline Hyclate

20 mg sub-antimicrobial dose doxycycline BID

EXPERIMENTAL

Oral, 12 weeks

Drug: Doxycycline Hyclate

Interventions

Doxycycline HyclateDRUG

100 mg vs 20 mg doxycycline hyclate BID for 12 weeks

100 mg standard dose doxycycline BID20 mg sub-antimicrobial dose doxycycline BID

Eligibility Criteria

Age13 Years - 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Documented moderate to severe facial acne

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Messenger Dermatology Clinic

Lansing, Michigan, 48912, United States

Location

MeSH Terms

Conditions

Acne Vulgaris

Interventions

Doxycycline

Condition Hierarchy (Ancestors)

Acneiform EruptionsSkin DiseasesSkin and Connective Tissue DiseasesSebaceous Gland Diseases

Intervention Hierarchy (Ancestors)

TetracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic Compounds

Results Point of Contact

Title
Erika Malana
Organization
Michigan State University
malanaer@msu.edu
5173038716

Study Officials

  • Michelle Gallagher, DO

    Michigan State University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

May 26, 2022

First Posted

June 1, 2022

Study Start

November 19, 2020

Primary Completion

November 8, 2021

Study Completion

November 8, 2021

Last Updated

April 3, 2023

Results First Posted

April 3, 2023

Record last verified: 2023-03

Locations

US(1)