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
2 other identifiers
interventional
90
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Aug 2008
Shorter than P25 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2008
CompletedFirst Submitted
Initial submission to the registry
March 24, 2009
CompletedFirst Posted
Study publicly available on registry
March 26, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2009
CompletedMarch 26, 2009
March 1, 2009
10 months
March 24, 2009
March 24, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of patients whom inflammatory lesions were decreased %50 or more
two months
Secondary Outcomes (1)
the number of patients whom were observed side effects
two months
Study Arms (2)
A
OTHERinstructed nadifloxacine 1% cream twice dailly, and placebo for benzoyl peroxide 5% solution once dailly
B
OTHERinstructed nadifloxacine 1% cream twice dailly, and active benzoyl peroxide 5% solution once dailly
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Marmara University school of medicine
Istanbul, Turkey (Türkiye)
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Züleyha Yazıcı, doktor
Marmara University
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
March 24, 2009
First Posted
March 26, 2009
Study Start
August 1, 2008
Primary Completion
June 1, 2009
Study Completion
June 1, 2009
Last Updated
March 26, 2009
Record last verified: 2009-03