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
Recruitment status was Recruiting
Sponsor:
Darier
Information provided by:
Darier
ClinicalTrials.gov Identifier:
NCT00988026
First received: September 30, 2009
Last updated: NA
Last verified: September 2009
History: No changes posted
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Received Date ICMJE | September 30, 2009 | ||||||||
| Last Updated Date | September 30, 2009 | ||||||||
| Start Date ICMJE | June 2009 | ||||||||
| Estimated Primary Completion Date | February 2010 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Number of inflammatory and non-inflammatory acne lesions [ Time Frame: 8 weeks ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | No Changes Posted | ||||||||
| Current Secondary Outcome Measures ICMJE |
Incidence of local and systemic adverse events [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ] | ||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Safety and Efficacy Comparison of Minocycline Microgranules Versus Lymecycline in the Treatment of Mild to Moderate Acne | ||||||||
| Official Title ICMJE | 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 | ||||||||
| 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. |
||||||||
| Detailed Description | Not Provided | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Phase 4 | ||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
||||||||
| Condition ICMJE | Mild to Moderate Acne | ||||||||
| Intervention ICMJE | Drug: Minocycline vs Lymecycline
Minocycline 100 mg OD per mouth for 8 weeks. Lymecycline 300 mg OD per mouth for 8 weeks. |
||||||||
| Study Arm (s) |
|
||||||||
| Publications * | Not Provided | ||||||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||||||
| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 168 | ||||||||
| Estimated Completion Date | April 2010 | ||||||||
| Estimated Primary Completion Date | February 2010 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||||||||
| Gender | Both | ||||||||
| Ages | 14 Years to 30 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
|
||||||||
| Location Countries ICMJE | Mexico | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00988026 | ||||||||
| Other Study ID Numbers ICMJE | MXMIN-001 | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| Responsible Party | Luis Leobardo Velázquez-Arenas, Hospital "Dr. José Eleuterio González" de la Universidad Autónoma de Nuevo Léon | ||||||||
| Study Sponsor ICMJE | Darier | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE | Not Provided | ||||||||
| Information Provided By | Darier | ||||||||
| Verification Date | September 2009 | ||||||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||||||