Back to resultsComparison of Nadifloxacin Cream Alone and With Benzoyl Peroxide Solution in the Treatment of Acne
Primary Purpose
Acne Vulgaris
Status
Unknown status
Phase
Phase 3
Locations
Turkey
Study Type
Interventional
Intervention
benzoyl peroxide
nadifloxacine
Sponsored by
About this trial
This is an interventional treatment trial for Acne Vulgaris focused on measuring Acne, Nadifloxacin, benzoyl peroxide
Eligibility Criteria
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
Sites / Locations
- Marmara University school of medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
A
B
Arm Description
instructed nadifloxacine 1% cream twice dailly, and placebo for benzoyl peroxide 5% solution once dailly
instructed nadifloxacine 1% cream twice dailly, and active benzoyl peroxide 5% solution once dailly
Outcomes
Primary Outcome Measures
Number of patients whom inflammatory lesions were decreased %50 or more
Secondary Outcome Measures
the number of patients whom were observed side effects
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00869492
Brief Title
Comparison of Nadifloxacin Cream Alone and With Benzoyl Peroxide Solution in the Treatment of Acne
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2009
Overall Recruitment Status
Unknown status
Study Start Date
August 2008 (undefined)
Primary Completion Date
June 2009 (Anticipated)
Study Completion Date
June 2009 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Marmara University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acne Vulgaris
Keywords
Acne, Nadifloxacin, benzoyl peroxide
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Other
Arm Description
instructed nadifloxacine 1% cream twice dailly, and placebo for benzoyl peroxide 5% solution once dailly
Arm Title
B
Arm Type
Other
Arm Description
instructed nadifloxacine 1% cream twice dailly, and active benzoyl peroxide 5% solution once dailly
Intervention Type
Drug
Intervention Name(s)
benzoyl peroxide
Other Intervention Name(s)
Aknefug BP5 lotion
Intervention Description
benzoyl peroxide %5 solution once dailly
Intervention Type
Drug
Intervention Name(s)
nadifloxacine
Other Intervention Name(s)
Nadixa 1% cream
Intervention Description
Nadifloxacine 1% cream twice dailly
Primary Outcome Measure Information:
Title
Number of patients whom inflammatory lesions were decreased %50 or more
Time Frame
two months
Secondary Outcome Measure Information:
Title
the number of patients whom were observed side effects
Time Frame
two months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Züleyha Yazıcı, doktor
Organizational Affiliation
Marmara University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Marmara University school of medicine
City
Istanbul
Country
Turkey
12. IPD Sharing Statement
Learn more about this trial
Comparison of Nadifloxacin Cream Alone and With Benzoyl Peroxide Solution in the Treatment of Acne
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