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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2009 by Marmara University.
Recruitment status was:  Active, not recruiting
Information provided by:
Marmara University Identifier:
First received: March 24, 2009
Last updated: NA
Last verified: March 2009
History: No changes posted
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 Intervention Phase
Acne Vulgaris Drug: benzoyl peroxide Drug: nadifloxacine Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Marmara University:

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

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

Estimated Enrollment: 90
Study Start Date: August 2008
Estimated Study Completion Date: June 2009
Estimated Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

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
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Please refer to this study by its identifier: NCT00869492

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

Responsible Party: Züleyha Yazıcı, Dermatology Department of Marmara University School of Medicine Identifier: NCT00869492     History of Changes
Other Study ID Numbers: mar-der1
Study First Received: March 24, 2009
Last Updated: March 24, 2009

Keywords provided by Marmara University:
benzoyl peroxide

Additional relevant MeSH terms:
Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Sebaceous Gland Diseases
Pharmaceutical Solutions
Benzoyl Peroxide
Dermatologic Agents
Anti-Bacterial Agents
Anti-Infective Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents processed this record on August 17, 2017