Safety and Efficacy Comparison of Minocycline Microgranules Versus Lymecycline in the Treatment of Mild to Moderate Acne
MXMIN-001
1 other identifier
interventional
168
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Jun 2009
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2009
CompletedFirst Submitted
Initial submission to the registry
September 30, 2009
CompletedFirst Posted
Study publicly available on registry
October 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2010
CompletedOctober 1, 2009
September 1, 2009
8 months
September 30, 2009
September 30, 2009
Conditions
Outcome Measures
Primary Outcomes (1)
Number of inflammatory and non-inflammatory acne lesions
8 weeks
Secondary Outcomes (1)
Incidence of local and systemic adverse events
8 weeks
Study Arms (2)
Minocycline 100 mg
EXPERIMENTALMinocycline
Lymecycline 300 mg
ACTIVE COMPARATORGroup B: Lymecycline
Interventions
Minocycline 100 mg OD per mouth for 8 weeks. Lymecycline 300 mg OD per mouth for 8 weeks.
Eligibility Criteria
You may qualify if:
- Both gender
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Darierlead
Study Sites (1)
Servicio de Dermatología. Hospital " Dr. José Eleuterio González" de la Universidad Autónoma de Nuevo León
Monterrey, Nuevo León, 64460, Mexico
Related Publications (1)
Ocampo-Candiani J, Velazquez-Arenas LL, de la Fuente-Garcia A, Trevino-Gomezharper C, Berber A. Safety and efficacy comparison of minocycline microgranules vs lymecycline in the treatment of mild to moderate acne: randomized, evaluator-blinded, parallel, and prospective clinical trial for 8 weeks. J Drugs Dermatol. 2014 Jun;13(6):671-6.
PMID: 24918556DERIVED
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 30, 2009
First Posted
October 1, 2009
Study Start
June 1, 2009
Primary Completion
February 1, 2010
Study Completion
April 1, 2010
Last Updated
October 1, 2009
Record last verified: 2009-09