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

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

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00869492

Enrollment

Registered

2009-03-26

Start date

2008-08-31

Completion date

2009-06-30

Last updated

2009-03-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acne Vulgaris

Keywords

Acne, Nadifloxacin, benzoyl peroxide

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.

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.

Interventions

DRUGbenzoyl peroxide

benzoyl peroxide %5 solution once dailly

DRUGnadifloxacine

Nadifloxacine 1% cream twice dailly

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

14 Years to 40 Years

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
the number of patients whom were observed side effects	two months

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026