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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2009 by Marmara University.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Marmara University
ClinicalTrials.gov Identifier:
NCT00869492
First received: March 24, 2009
Last updated: NA
Last verified: March 2009
History: No changes posted
  Purpose

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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: No ]

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

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
A
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
B
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.

  Eligibility

Ages Eligible for Study:   14 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00869492

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

No publications provided

Responsible Party: Züleyha Yazıcı, Dermatology Department of Marmara University School of Medicine
ClinicalTrials.gov Identifier: NCT00869492     History of Changes
Other Study ID Numbers: mar-der1, dermatology1
Study First Received: March 24, 2009
Last Updated: March 24, 2009
Health Authority: Turkey: Ethics Committee
Turkey: Ministry of Health

Keywords provided by Marmara University:
Acne
Nadifloxacin
benzoyl peroxide

Additional relevant MeSH terms:
Acne Vulgaris
Acneiform Eruptions
Facial Dermatoses
Sebaceous Gland Diseases
Skin Diseases
Benzoyl Peroxide
Nadifloxacin
Pharmaceutical Solutions
Anti-Bacterial Agents
Anti-Infective Agents
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Topoisomerase II Inhibitors
Topoisomerase Inhibitors

ClinicalTrials.gov processed this record on October 20, 2014