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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00869492
Recruitment Status : Unknown
Verified March 2009 by Marmara University.
Recruitment status was:  Active, not recruiting
First Posted : March 26, 2009
Last Update Posted : March 26, 2009
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Acne Vulgaris Drug: benzoyl peroxide Drug: nadifloxacine Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Study Start Date : August 2008
Estimated Primary Completion Date : June 2009
Estimated Study Completion Date : June 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne

Arm Intervention/treatment
instructed nadifloxacine 1% cream twice dailly, and placebo for benzoyl peroxide 5% solution once dailly
Drug: nadifloxacine
Nadifloxacine 1% cream twice dailly
Other Name: Nadixa 1% cream

instructed nadifloxacine 1% cream twice dailly, and active benzoyl peroxide 5% solution once dailly
Drug: benzoyl peroxide
benzoyl peroxide %5 solution once dailly
Other Name: Aknefug BP5 lotion

Drug: nadifloxacine
Nadifloxacine 1% cream twice dailly
Other Name: Nadixa 1% cream

Primary Outcome Measures :
  1. Number of patients whom inflammatory lesions were decreased %50 or more [ Time Frame: two months ]

Secondary Outcome Measures :
  1. the number of patients whom were observed side effects [ Time Frame: two months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years to 40 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00869492

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Marmara University school of medicine
Istanbul, Turkey
Sponsors and Collaborators
Marmara University
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Principal Investigator: Züleyha Yazıcı, doktor Marmara University

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Responsible Party: Züleyha Yazıcı, Dermatology Department of Marmara University School of Medicine Identifier: NCT00869492     History of Changes
Other Study ID Numbers: mar-der1
First Posted: March 26, 2009    Key Record Dates
Last Update Posted: March 26, 2009
Last Verified: March 2009
Keywords provided by Marmara University:
benzoyl peroxide
Additional relevant MeSH terms:
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Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Sebaceous Gland Diseases
Benzoyl Peroxide
Pharmaceutical Solutions
Dermatologic Agents
Anti-Bacterial Agents
Anti-Infective Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents