We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2009 by Darier.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00988026
First Posted: October 1, 2009
Last Update Posted: October 1, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Darier
  Purpose
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.

Condition Intervention Phase
Mild to Moderate Acne Drug: Minocycline vs Lymecycline Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Darier:

Primary Outcome Measures:
  • Number of inflammatory and non-inflammatory acne lesions [ Time Frame: 8 weeks ]

Secondary Outcome Measures:
  • Incidence of local and systemic adverse events [ Time Frame: 8 weeks ]

Estimated Enrollment: 168
Study Start Date: June 2009
Estimated Study Completion Date: April 2010
Estimated Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Minocycline 100 mg
Minocycline
Drug: Minocycline vs Lymecycline
Minocycline 100 mg OD per mouth for 8 weeks. Lymecycline 300 mg OD per mouth for 8 weeks.
Active Comparator: Lymecycline 300 mg
Group B: Lymecycline
Drug: Minocycline vs Lymecycline
Minocycline 100 mg OD per mouth for 8 weeks. Lymecycline 300 mg OD per mouth for 8 weeks.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   14 Years to 30 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00988026


Contacts
Contact: Luis Leobardo Velázquez-Arenas, MD (5281)83481465 leovel2002@yahoo.com.mx
Contact: Jorge Ocampo-Candiani, MD (5281)83481465 jocampo2000@yahoo.com.mx

Locations
Mexico
Servicio de Dermatología. Hospital " Dr. José Eleuterio González" de la Universidad Autónoma de Nuevo León Recruiting
Monterrey, Nuevo León, Mexico, 64460
Contact: Blanca Ojeda-Martínez, RN    (5281)83481465    blanca_ojeda21@hotmail.com   
Sponsors and Collaborators
Darier
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Luis Leobardo Velázquez-Arenas, Hospital "Dr. José Eleuterio González" de la Universidad Autónoma de Nuevo Léon
ClinicalTrials.gov Identifier: NCT00988026     History of Changes
Other Study ID Numbers: MXMIN-001
First Submitted: September 30, 2009
First Posted: October 1, 2009
Last Update Posted: October 1, 2009
Last Verified: September 2009

Additional relevant MeSH terms:
Minocycline
Lymecycline
Anti-Bacterial Agents
Anti-Infective Agents