Comparison of Nadifloxacin Cream Alone and With Benzoyl Peroxide Solution in the Treatment of Acne
This trial is active, not recruiting.
|Treatments||benzoyl peroxide, nadifloxacine|
|Start date||August 2008|
|End date||June 2009|
|Trial size||90 participants|
|Trial identifier||NCT00869492, dermatology1, mar-der1|
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.
|Endpoint classification||efficacy study|
|Intervention model||parallel assignment|
|Masking||double blind (subject, investigator)|
Number of patients whom inflammatory lesions were decreased %50 or more
time frame: two months
the number of patients whom were observed side effects
time frame: two months
Male or female participants from 14 years up to 40 years old.
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
|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|
|Principal investigator||Züleyha Yazıcı, doktor|
|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.|
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