Overview

This trial is active, not recruiting.

Condition acne vulgaris
Treatments benzoyl peroxide, nadifloxacine
Phase phase 3
Sponsor Marmara University
Start date August 2008
End date June 2009
Trial size 90 participants
Trial identifier NCT00869492, dermatology1, mar-der1

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose treatment
Arm
(Other)
instructed nadifloxacine 1% cream twice dailly, and placebo for benzoyl peroxide 5% solution once dailly
nadifloxacine Nadixa 1% cream
Nadifloxacine 1% cream twice dailly
(Other)
instructed nadifloxacine 1% cream twice dailly, and active benzoyl peroxide 5% solution once dailly
benzoyl peroxide Aknefug BP5 lotion
benzoyl peroxide %5 solution once dailly
nadifloxacine Nadixa 1% cream
Nadifloxacine 1% cream twice dailly

Primary Outcomes

Measure
Number of patients whom inflammatory lesions were decreased %50 or more
time frame: two months

Secondary Outcomes

Measure
the number of patients whom were observed side effects
time frame: two months

Eligibility Criteria

Male or female participants from 14 years up to 40 years old.

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

Additional Information

Official title A Double Blind Randomised Comparison of Nadifloxacin 1% Cream Alone and Nadifloxacine %1 Cream With Benzoyl Peroxide 5% Solution in the Treatment of Mild to Moderate Facial Acne Vulgaris
Principal investigator Züleyha Yazıcı, doktor
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.
Trial information was received from ClinicalTrials.gov and was last updated in March 2009.
Information provided to ClinicalTrials.gov by Marmara University.