Safety and Efficacy Comparison of Minocycline Microgranules Versus Lymecycline in the Treatment of Mild to Moderate Acne

NCT ID: NCT00988026

Last Updated: 2009-10-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

168 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-06-30

Study Completion Date

2010-04-30

Brief Summary

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This is a clinical trial to compare the benefits and possible adverse events of two antibiotic treatments for mild to moderate acne. It is expected that minocycline microgranules will be more effective than lymecycline with a better adverse events profile.

Detailed Description

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Conditions

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Mild to Moderate Acne

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Caregivers Investigators Outcome Assessors

Study Groups

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Minocycline 100 mg

Minocycline

Group Type EXPERIMENTAL

Minocycline vs Lymecycline

Intervention Type DRUG

Minocycline 100 mg OD per mouth for 8 weeks. Lymecycline 300 mg OD per mouth for 8 weeks.

Lymecycline 300 mg

Group B: Lymecycline

Group Type ACTIVE_COMPARATOR

Minocycline vs Lymecycline

Intervention Type DRUG

Minocycline 100 mg OD per mouth for 8 weeks. Lymecycline 300 mg OD per mouth for 8 weeks.

Interventions

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Minocycline vs Lymecycline

Minocycline 100 mg OD per mouth for 8 weeks. Lymecycline 300 mg OD per mouth for 8 weeks.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Both gender
* 14 to 30 years old
* Mild to moderate acne
* Face localization
* At least 20 non-inflammatory lesions OR
* At least 15 inflammatory lesions OR
* At least 30 total lesions AND
* Less than 5 nodular lesions

Exclusion Criteria

* Patients younger than 14 or older than 30 years old
* Less than 20 non-inflammatory lesions OR
* Less than 15 inflammatory lesions OR
* Less than 30 total lesions
* Patients with severe acne
* More than 5 nodular lesions OR
* More than 50 inflammatory lesions OR
* More than 125 total lesions
* Pregnant women
* Lactating women
Minimum Eligible Age

14 Years

Maximum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Darier

INDUSTRY

Sponsor Role lead

Responsible Party

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Hospital "Dr. José Eleuterio González" de la Universidad Autónoma de Nuevo Léon

Locations

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Servicio de Dermatología. Hospital " Dr. José Eleuterio González" de la Universidad Autónoma de Nuevo León

Monterrey, Nuevo León, Mexico

Site Status RECRUITING

Countries

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Mexico

Central Contacts

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Luis Leobardo Velázquez-Arenas, MD

Role: CONTACT

(5281)83481465

Jorge Ocampo-Candiani, MD

Role: CONTACT

(5281)83481465

Facility Contacts

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Blanca Ojeda-Martínez, RN

Role: primary

(5281)83481465

References

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Ocampo-Candiani J, Velazquez-Arenas LL, de la Fuente-Garcia A, Trevino-Gomezharper C, Berber A. Safety and efficacy comparison of minocycline microgranules vs lymecycline in the treatment of mild to moderate acne: randomized, evaluator-blinded, parallel, and prospective clinical trial for 8 weeks. J Drugs Dermatol. 2014 Jun;13(6):671-6.

Reference Type DERIVED
PMID: 24918556 (View on PubMed)

Other Identifiers

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MXMIN-001

Identifier Type: -

Identifier Source: org_study_id

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