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

Sponsor:	Darier
Information provided by:	Darier
ClinicalTrials.gov Identifier:	NCT00988026

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 IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study
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

Drug Information available for: Minocycline Minocycline hydrochloride Lymecycline

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
Minocycline 100 mg: Experimental Minocycline	Drug: Minocycline vs Lymecycline Minocycline 100 mg OD per mouth for 8 weeks. Lymecycline 300 mg OD per mouth for 8 weeks.
Lymecycline 300 mg: Active Comparator 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, Nuevo León
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:	Hospital "Dr. José Eleuterio González" de la Universidad Autónoma de Nuevo Léon ( Luis Leobardo Velázquez-Arenas )
Study ID Numbers:	MXMIN-001
Study First Received:	September 30, 2009
Last Updated:	September 30, 2009
ClinicalTrials.gov Identifier:	NCT00988026 History of Changes
Health Authority:	Mexico: Federal Commission for Sanitary Risks Protection

Additional relevant MeSH terms:

Anti-Infective Agents
Anti-Bacterial Agents
Minocycline
Facial Dermatoses
Skin Diseases
Acneiform Eruptions

Therapeutic Uses
Lymecycline
Sebaceous Gland Diseases
Pharmacologic Actions
Acne Vulgaris

ClinicalTrials.gov processed this record on February 08, 2010