Comparison of Nadifloxacin Cream Alone and With Benzoyl Peroxide Solution in the Treatment of Acne

Phase 3

• Conditions: Acne Vulgaris
• Interventions: Drug: nadifloxacine; Drug: benzoyl peroxide

• Registration Number: NCT00869492
• Lead Sponsor: Marmara University

Brief Summary

The purpose of this study is to determine whether using of nadifloxacine 1% cream and benzoyl peroxide 5% solution together is more effective than using nadifloxacine alone in the treatment of mild to moderate facial acne.

Detailed Description

Nadifloxacin; a new topical antibiotic for the treatment of acne has recently been marketed in our country. Only a few studies on its use and effectiviness could be found in the literature. Nadifloxacin may be an alternative to other topical antibiotics and benzoyl peroxide or its use along with benzoyl peroxide may be more effective and rational to prevent possible future resistance.

Study Timeline

• Study Start: 2008-08
• Status Verified: 2009-03
• Study First Submitted: 2009-03-24
• Study First Submitted QC: 2009-03-24
• Last Update Submitted: 2009-03-24
• Study First Posted: 2009-03-26
• Last Update Posted: 2009-03-26
• Primary Completion: 2009-06
• Study Completion: 2009-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

• Clinical diagnosis of mild to moderate facial acne vulgaris
• Must have at least 10 inflammatory and/or non-inflammatory and no more than 3 nodulocystic acne lesions

Exclusion Criteria

• Nodulocystic acne lesions more than 3 and pure comedonal acne
• Additional truncal acne needs systemic therapy
• Usage of topical treatments for acne in last 2 weeks, systemic antibiotic in last 4 weeks, systemic isotretinoin in last 6 months
• Application of chemical peels and laser in last 4 weeks
• Usage of hormones in last 3 months
• Clinical signs of hyperandrogenism in females
• Pregrancy and lactation
• Hypersensitivity to interventions
• Additional facial skin diseases (eg. atopic and seborreic dermatitis)
• Photosensitive disorders and usage of drugs which can trigger Photosensitive conditions

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	nadifloxacine	instructed nadifloxacine 1% cream twice dailly, and placebo for benzoyl peroxide 5% solution once dailly
B	nadifloxacine	instructed nadifloxacine 1% cream twice dailly, and active benzoyl peroxide 5% solution once dailly
B	benzoyl peroxide	instructed nadifloxacine 1% cream twice dailly, and active benzoyl peroxide 5% solution once dailly

Primary Outcome Measures

Name	Time	Method
Number of patients whom inflammatory lesions were decreased %50 or more	two months

Secondary Outcome Measures

Name	Time	Method
the number of patients whom were observed side effects	two months

Trial Locations

Locations (1)

Marmara University school of medicine; 🇹🇷 Istanbul, Turkey