NCT02688738

Brief Summary

The purpose of this study is to evaluate the ability of oral doxycycline to decrease the colonization of Propionibacterium acnes in the dermis of the shoulder.

Trial Health

50
Monitor

Trial Health Score

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

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2015

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

February 11, 2016

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 23, 2016

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Last Updated

February 23, 2016

Status Verified

February 1, 2016

Enrollment Period

1.8 years

First QC Date

February 11, 2016

Last Update Submit

February 17, 2016

Conditions

Propionibacterium

Outcome Measures

Primary Outcomes (1)

  • Quantification of P acnes grown from anaerobic or aerobic culture

    within 14 days of surgery

Study Arms (2)

Control

NO INTERVENTION

Standard of care

Treatment

ACTIVE COMPARATOR

Oral doxycycline

Drug: Doxycycline

Interventions

DoxycyclineDRUG
Treatment

Eligibility Criteria

Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • All male patients (\>18 years of age) undergoing shoulder arthroscopy

You may not qualify if:

  • Female patients
  • patients with active acne
  • patients who have taken antibiotics in the past month
  • doxycycline allergy
  • benzoyl peroxide allergy
  • clindamycin allergy
  • patients with psoriatic/eczematous or other lesions on the shoulder girdle.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Doxycycline

Intervention Hierarchy (Ancestors)

TetracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic Compounds

Study Design

Study Type
interventional
Phase
not applicable
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 11, 2016

First Posted

February 23, 2016

Study Start

March 1, 2015

Primary Completion

December 1, 2016

Last Updated

February 23, 2016

Record last verified: 2016-02