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

March 24, 2009 updated by: Marmara University

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

90

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey
        • Marmara University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 40 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: A
instructed nadifloxacine 1% cream twice dailly, and placebo for benzoyl peroxide 5% solution once dailly
Drug: nadifloxacine
Nadifloxacine 1% cream twice dailly
Other Names:
  • Nadixa 1% cream
Other: B
instructed nadifloxacine 1% cream twice dailly, and active benzoyl peroxide 5% solution once dailly
Drug: nadifloxacine
Nadifloxacine 1% cream twice dailly
Other Names:
  • Nadixa 1% cream
Drug: benzoyl peroxide
benzoyl peroxide %5 solution once dailly
Other Names:
  • Aknefug BP5 lotion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of patients whom inflammatory lesions were decreased %50 or more
Time Frame: two months
two months

Secondary Outcome Measures

Outcome Measure
Time Frame
the number of patients whom were observed side effects
Time Frame: two months
two months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Marmara University

Investigators

  • Principal Investigator: Züleyha Yazıcı, doktor, Marmara University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2008

Primary Completion (Anticipated)

June 1, 2009

Study Completion (Anticipated)

June 1, 2009

Study Registration Dates

First Submitted

March 24, 2009

First Submitted That Met QC Criteria

March 24, 2009

First Posted (Estimate)

March 26, 2009

Study Record Updates

Last Update Posted (Estimate)

March 26, 2009

Last Update Submitted That Met QC Criteria

March 24, 2009

Last Verified

March 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • mar-der1
  • dermatology1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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