Acne VulgarisPhase 3NCT00869492
Comparison of Nadifloxacin Cream Alone and With Benzoyl Peroxide Solution in the Treatment of Acne
A Phase 3 study testing benzoyl peroxide and nadifloxacine in people with Acne Vulgaris, run by Marmara University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 14 to 40 years
- Conditions the study is for
- Acne Vulgaris
- What is being tested?
- benzoyl peroxide and nadifloxacine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Aug 2008to Jun 2009
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 40 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Marmara University school of medicine
Istanbul
About this study
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
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.
Read the 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.
- Conditions
- Acne Vulgaris
- Being tested
- benzoyl peroxide, nadifloxacine
- Keywords
- Acne, Nadifloxacin, benzoyl peroxide
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
benzoyl peroxideDrug
Also called Aknefug BP5 lotion
benzoyl peroxide %5 solution once dailly
nadifloxacineDrug
Also called Nadixa 1% cream
Nadifloxacine 1% cream twice dailly
| Study group | Role | What they receive |
|---|---|---|
| A | Other | instructed nadifloxacine 1% cream twice dailly, and placebo for benzoyl peroxide 5% solution once dailly Receives: Drug: nadifloxacine |
| B | Other | instructed nadifloxacine 1% cream twice dailly, and active benzoyl peroxide 5% solution once dailly Receives: Drug: benzoyl peroxide; Drug: nadifloxacine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients whom inflammatory lesions were decreased %50 or more
Measured: two months
Secondary outcomes (1)
the number of patients whom were observed side effects
Measured: two months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2009 (estimated)
- Study startAug 2008
- Primary completionJun 2009 (estimated)
- Study completionJun 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acne VulgarisStudies of the same condition, open and under way.
- More trials run by Marmara UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Investigators
- Züleyha Yazıcı, doktor, Principal investigator, Marmara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00869492
- Sponsor's protocol ID
- mar-der1
- Other IDs
- dermatology1
- Status last verified
- Mar 2009
- First submitted
- 24 Mar 2009
- Last updated
- 26 Mar 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00869492
- Acronym / sponsor ID
- mar-der1
- Conditions
- Acne Vulgaris
- Keywords
- Acne, Nadifloxacin, benzoyl peroxide
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- Aug 2008
- Primary completion
- Jun 2009 (estimated)
- Study completion
- Jun 2009 (estimated)
- First posted
- 26 Mar 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Other | Drug: nadifloxacineinstructed nadifloxacine 1% cream twice dailly, and placebo for benzoyl peroxide 5% solution once dailly |
| B | Other | Drug: benzoyl peroxide, Drug: nadifloxacineinstructed nadifloxacine 1% cream twice dailly, and active benzoyl peroxide 5% solution once dailly |
Who may qualify
- Ages
- 14 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| benzoyl peroxideAlso: Aknefug BP5 lotionbenzoyl peroxide %5 solution once dailly | Drug | B |
| nadifloxacineAlso: Nadixa 1% creamNadifloxacine 1% cream twice dailly | Drug | A, B |
Primary outcome
Number of patients whom inflammatory lesions were decreased %50 or more
Time frame: two months
1 secondary outcome
the number of patients whom were observed side effects
Time frame: two months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Züleyha Yazıcı, doktor principal investigator
Marmara University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing benzoyl peroxide and nadifloxacine in people with Acne Vulgaris, run by Marmara University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Mar 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients whom inflammatory lesions were decreased %50 or more (time frame: two months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2009.