Subantimicrobial Doxycycline in Acne

NCT ID: NCT05399290

Last Updated: 2023-04-03

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-19

Study Completion Date

2021-11-08

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.

Detailed Description

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Conditions

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Acne Vulgaris Pediatrics

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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100 mg standard dose doxycycline BID

Oral, 12 weeks

Group Type ACTIVE_COMPARATOR

Doxycycline Hyclate

Intervention Type DRUG

100 mg vs 20 mg doxycycline hyclate BID for 12 weeks

20 mg sub-antimicrobial dose doxycycline BID

Oral, 12 weeks

Group Type EXPERIMENTAL

Doxycycline Hyclate

Intervention Type DRUG

100 mg vs 20 mg doxycycline hyclate BID for 12 weeks

Interventions

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Doxycycline Hyclate

100 mg vs 20 mg doxycycline hyclate BID for 12 weeks

Intervention Type DRUG

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
Minimum Eligible Age

13 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Michigan State University

OTHER

Sponsor Role lead

Responsible Party

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Michelle Gallagher

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Michelle Gallagher, DO

Role: PRINCIPAL_INVESTIGATOR

Michigan State University

Locations

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Messenger Dermatology Clinic

Lansing, Michigan, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

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STUDY00003269

Identifier Type: -

Identifier Source: org_study_id

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