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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Acne Vulgaris

Intervention / Treatment
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* Drug: benzoyl peroxide
* Drug: nadifloxacine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 14 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: A<br>instructed nadifloxacine 1% cream twice dailly, and placebo for benzoyl peroxide 5% solution once dailly | Drug: nadifloxacine<br>* Nadifloxacine 1% cream twice dailly<br>* Other names: Nadixa 1% cream;|
| Other: B<br>instructed nadifloxacine 1% cream twice dailly, and active benzoyl peroxide 5% solution once dailly | Drug: benzoyl peroxide<br>* benzoyl peroxide %5 solution once dailly<br>* Other names: Aknefug BP5 lotion;Drug: nadifloxacine<br>* Nadifloxacine 1% cream twice dailly<br>* Other names: Nadixa 1% cream;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients whom inflammatory lesions were decreased %50 or more |  | two months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the number of patients whom were observed side effects |  | two months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acne, Nadifloxacin, benzoyl peroxide