Safety and Efficacy Comparison of Minocycline Microgranules Versus Lymecycline in the Treatment of Mild to Moderate Acne
Information source: Darier
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Mild to Moderate Acne
Intervention: Minocycline vs Lymecycline (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Darier Overall contact: Luis Leobardo Velázquez-Arenas, MD, Phone: (5281)83481465, Email: leovel2002@yahoo.com.mx
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.
Clinical Details
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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Number of inflammatory and non-inflammatory acne lesions
Secondary outcome: Incidence of local and systemic adverse events
Eligibility
Minimum age: 14 Years.
Maximum age: 30 Years.
Gender(s): Both.
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
Locations and Contacts
Luis Leobardo Velázquez-Arenas, MD, Phone: (5281)83481465, Email: leovel2002@yahoo.com.mx
Servicio de Dermatología. Hospital " Dr. José Eleuterio González" de la Universidad Autónoma de Nuevo León, Monterrey, Nuevo León 64460, Mexico; Recruiting Blanca Ojeda-Martínez, RN, Phone: (5281)83481465, Email: blanca_ojeda21@hotmail.com
Additional Information
Starting date: June 2009
Last updated: September 30, 2009
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