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Safety and Efficacy Comparison of Minocycline Microgranules Versus Lymecycline in the Treatment of Mild to Moderate Acne (MXMIN-001)

Primary Purpose

Mild to Moderate Acne

Status
Unknown status
Phase
Phase 4
Locations
Mexico
Study Type
Interventional
Intervention
Minocycline vs Lymecycline
Sponsored by
Darier
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mild to Moderate Acne

Eligibility Criteria

14 Years - 30 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Minocycline 100 mg

Lymecycline 300 mg

Arm Description

Minocycline

Group B: Lymecycline

Outcomes

Primary Outcome Measures

Number of inflammatory and non-inflammatory acne lesions

Secondary Outcome Measures

Incidence of local and systemic adverse events

Full Information

First Posted
September 30, 2009
Last Updated
September 30, 2009
Sponsor
Darier
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1. Study Identification

Unique Protocol Identification Number
NCT00988026
Brief Title
Safety and Efficacy Comparison of Minocycline Microgranules Versus Lymecycline in the Treatment of Mild to Moderate Acne
Acronym
MXMIN-001
Official Title
Safety and Efficacy Comparison of Minocycline Microgranules vs Lymecycline in the Treatment of Mild to Moderate Acne. Randomized, Double Blind, Parallel and Prospective Clinical Trial for 8 Weeks
Study Type
Interventional

2. Study Status

Record Verification Date
September 2009
Overall Recruitment Status
Unknown status
Study Start Date
June 2009 (undefined)
Primary Completion Date
February 2010 (Anticipated)
Study Completion Date
April 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Darier

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild to Moderate Acne

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
168 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Minocycline 100 mg
Arm Type
Experimental
Arm Description
Minocycline
Arm Title
Lymecycline 300 mg
Arm Type
Active Comparator
Arm Description
Group B: Lymecycline
Intervention Type
Drug
Intervention Name(s)
Minocycline vs Lymecycline
Intervention Description
Minocycline 100 mg OD per mouth for 8 weeks. Lymecycline 300 mg OD per mouth for 8 weeks.
Primary Outcome Measure Information:
Title
Number of inflammatory and non-inflammatory acne lesions
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Incidence of local and systemic adverse events
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Luis Leobardo Velázquez-Arenas, MD
Phone
(5281)83481465
Email
leovel2002@yahoo.com.mx
First Name & Middle Initial & Last Name or Official Title & Degree
Jorge Ocampo-Candiani, MD
Phone
(5281)83481465
Email
jocampo2000@yahoo.com.mx
Facility Information:
Facility Name
Servicio de Dermatología. Hospital " Dr. José Eleuterio González" de la Universidad Autónoma de Nuevo León
City
Monterrey
State/Province
Nuevo León
ZIP/Postal Code
64460
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Blanca Ojeda-Martínez, RN
Phone
(5281)83481465
Email
blanca_ojeda21@hotmail.com

12. IPD Sharing Statement

Citations:
PubMed Identifier
24918556
Citation
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.
Results Reference
derived

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

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