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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 because the information has not been verified recently.
Verified September 2009 by Darier.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Darier
ClinicalTrials.gov Identifier:
NCT00988026
First received: September 30, 2009
Last updated: NA
Last verified: September 2009
History: No changes posted
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Caregiver, 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:

MedlinePlus related topics: Acne
U.S. FDA Resources

Further study details as provided by Darier:

Primary Outcome Measures:
  • Number of inflammatory and non-inflammatory acne lesions [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Incidence of local and systemic adverse events [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   14 Years to 30 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: September 30, 2009
Last Updated: September 30, 2009
Health Authority: Mexico: Federal Commission for Sanitary Risks Protection

Additional relevant MeSH terms:
Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Facial Dermatoses
Sebaceous Gland Diseases
Lymecycline
 Minocycline
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013