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

Mild to Moderate Acne Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00988026
• Other study ID #: MXMIN-001
• Status: Recruiting
• Phase: Phase 4
• First received: September 30, 2009
• Last updated: September 30, 2009
• Start date: June 2009
• Est. completion date: April 2010

Study information

• Verified date: September 2009
• Source: Darier
• Contact: Luis Leobardo Velázquez-Arenas, MD
• Phone: (5281)83481465
• Email: leovel2002[@]yahoo.com.mx
• Is FDA regulated: No
• Health authority: Mexico: Federal Commission for Sanitary Risks Protection
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 168
• Est. completion date: April 2010
• Est. primary completion date: February 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 14 Years to 30 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Mild to Moderate Acne

Intervention

Drug:
• Minocycline vs Lymecycline
Minocycline 100 mg OD per mouth for 8 weeks. Lymecycline 300 mg OD per mouth for 8 weeks.

Locations

Country	Name	City	State
Mexico	Servicio de Dermatología. Hospital " Dr. José Eleuterio González" de la Universidad Autónoma de Nuevo León	Monterrey	Nuevo León

Sponsors (1)

Lead Sponsor	Collaborator
Darier

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of inflammatory and non-inflammatory acne lesions		8 weeks	No
Secondary	Incidence of local and systemic adverse events		8 weeks	Yes