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
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 |
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.
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Turkey | Marmara University school of medicine | Istanbul |
Lead Sponsor | Collaborator |
---|---|
Marmara University |
Turkey,
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 |
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