Safety and Efficacy Comparison of Minocycline Microgranules Versus Lymecycline in the Treatment of Mild to Moderate Acne (MXMIN-001)

Darier

Status and phase: Unknown; Phase 4

Conditions: Mild to Moderate Acne

Treatments: Drug: Minocycline vs Lymecycline

Study type: Interventional

Funder types: Industry

Identifiers

NCT00988026

MXMIN-001

Details and patient eligibility

About

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.

Enrollment: 168 estimated patients

Sex: All

Ages: 14 to 30 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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168 participants in 2 patient groups

Minocycline 100 mg

Experimental group

Description:

Minocycline

Treatment:

Drug: Minocycline vs Lymecycline

Lymecycline 300 mg

Active Comparator group

Description:

Group B: Lymecycline

Treatment:

Drug: Minocycline vs Lymecycline