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

Acne Vulgaris Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00869492
• Other study ID #: mar-der1
• Secondary ID: dermatology1
• Status: Active, not recruiting
• Phase: Phase 3
• First received: March 24, 2009
• Last updated: March 24, 2009
• Start date: August 2008
• Est. completion date: June 2009

Study information

• Verified date: March 2009
• Source: Marmara University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ethics CommitteeTurkey: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 90
• Est. completion date: June 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 14 Years to 40 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acne Vulgaris

Intervention

Drug:
• benzoyl peroxide
benzoyl peroxide %5 solution once dailly
• nadifloxacine
Nadifloxacine 1% cream twice dailly

Locations

Country	Name	City	State
Turkey	Marmara University school of medicine	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Marmara University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients whom inflammatory lesions were decreased %50 or more		two months	No
Secondary	the number of patients whom were observed side effects		two months	Yes