Evaluate Effectiveness of Epiduo® Gel in Reducing Antibiotic Sensitive & Resistant Strains of Propionibacterium (P)Acnes

Galderma

Status and phase: Completed; Phase 4

Conditions: P Acnes Colonization

Treatments: Drug: Adapalene 0.1%/Benzoyl Peroxide 2.5% Gel (Epiduo® Gel)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00907101

US10127

Details and patient eligibility

About

The purpose of this study is to evaluate the effectiveness of Epiduo® Gel in reducing antibiotic sensitive and resistant strains of P acnes in vivo.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Healthy adult male or female subjects 18 years of age and older, with no past or present history of any significant internal disease

• Subjects who:

  • show a high degree of fluorescence of the facial skin under a Wood's lamp, indicating the presence of P acnes
  • have Baseline P acnes count of > 10,000 per cm2 CFU of the facial skin (forehead)
  • have high level resistance to erythromycin, variable resistance to clindamycin, resistance to tetracycline and variable resistance to doxycycline and minocycline

Exclusion criteria

• Subjects who exhibit any skin disorders of an acute or chronic nature (e.g., psoriasis, eczema, etc)
• Subjects who have taken topical or systemic antibiotics within 4 weeks prior to baseline assessments
• Subjects who have used other medications which may influence skin surface P acnes levels
• Subjects who are unwilling to refrain from using toners, astringents or other drying agents on the face during the study

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Study Treatment

Experimental group

Description:

Adapalene 0.1%/Benzoyl Peroxide 2.5% Gel (Epiduo® Gel) Other Names: Epiduo® Gel Apply once daily

Treatment:

Drug: Adapalene 0.1%/Benzoyl Peroxide 2.5% Gel (Epiduo® Gel)