Treatment of Acne Vulgaris Grade II in a Short Period of Time.Phase 4NCT01260571
Clinical Study to Evaluate the Efficacy of Topical Medications Containing Benzoyl Peroxide and Sulfur in the Regression in the Short Time (24 Hours) of Moderate Acne Vulgaris Grade II (Pimples)
A Phase 4 study testing Benzoyl peroxide and sulfur in people with Treatment of Acne Vulgaris Grade II in a Short Period of Time., run by Zurita Laboratorio Farmaceutico Ltda. at 1 site in Brazil.
Trial summary
Sixty two subjects will take part in this study. The study is unic arm. The subjects used the product once and will be evaluated in the regression of pimples in the times 0,4,6,8 and 24 hours after application. A follow-up visit will be made 24 hours after initiation of treatment. Read more about this study
- Who is it for?
- Ages 12 to 35 years
- Conditions the study is for
- Treatment of Acne Vulgaris Grade II in a Short Period of Time.
- What is being tested?
- Benzoyl peroxide and sulfur
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteBrazil
- Study dates
- Jan 2011to Mar 2011
- Phase
- Phase 4
- 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 12 to 35 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Subjects of both sexes aged to 12 years to 35 years
- Oily skin prone to acne
- Presence of at least three inflammatory lesions, diagnosed as grade II acne vulgaris.
- Sign the informed Consent Form
- Comply the requirements and attend to study visits
Who cannot join
- Pregnancy (need for urinary pregnancy test for women of childbearing age)
- Lactation
- Presence of acne conglobata and nodulocystic
- Pathologies associated hormonal (thyroid diseases, ovaries micropolycystic)
- Drug use systemic corticosteroids, anticonvulsants and / or new drugs for up to one month before to selection.
- History of atopy or allergic cutaneous
Show all 9Show fewer
- History of hypersensitivity to benzoyl peroxide and sulfur
- Beginning or ending the use of contraceptives (for females)
- Intense sun exposure until one month before the evaluation
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Medcin Instituto da Pele
Osasco, São Paulo, 06023-000
Sergio Schalka, Doctor's, (11) 36816362, medicin@medicinonline.com.br
Sergio Schalka, Doctor's
About this study
Sixty two subjects will take part in this study. The study is unic arm. The subjects used the product once and will be evaluated in the regression of pimples in the times 0,4,6,8 and 24 hours after application.
A follow-up visit will be made 24 hours after initiation of treatment.
- Being tested
- Benzoyl peroxide and sulfur
- Keywords
- blackheads and pimples, Acne vulgaris grade II
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Benzoyl peroxide and sulfurDrug
topical cream, 5% benzoyl peroxide and 2% sulfur Frequency once to day Duration 24 hours
| Study group | Role | What they receive |
|---|---|---|
| Benzoyl Peroxide and Sulfur | Experimental | Topical Medications containing benzoyl peroxide and sulfur Receives: Drug: Benzoyl peroxide and sulfur |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical study to evaluate the efficacy of topical medications containing benzoyl peroxide and sulfur in the regression in the short time (24 hours) of moderate acne vulgaris grade II (pimples).
Clinical evolution of the target lesions for each experimental time regarding the parameters of reddening, size and general appearance of the lesion.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2010 (estimated)
- Study startJan 2011
- Primary completionMar 2011 (estimated)
- Study completionMar 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Treatment of Acne Vulgaris Grade II in a Short Period of Time.Studies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zurita Laboratorio Farmaceutico Ltda.
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01260571
- Sponsor's protocol ID
- EAA 554-10/v6
- Status last verified
- Sep 2010
- First submitted
- 13 Dec 2010
- Last updated
- 15 Dec 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study to Evaluate the Efficacy of Topical Medications Containing Benzoyl Peroxide and Sulfur in the Regression in the Short Time (24 Hours) of Moderate Acne Vulgaris Grade II (Pimples)
- ClinicalTrials.gov ID
- NCT01260571
- Acronym / sponsor ID
- EAA 554-10/v6
- Keywords
- blackheads and pimples, Acne vulgaris grade II
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- Zurita Laboratorio Farmaceutico Ltda.Industry (pharma, biotech, devices)
- Study start
- Jan 2011
- Primary completion
- Mar 2011 (estimated)
- Study completion
- Mar 2011 (estimated)
- First posted
- 15 Dec 2010 (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.
Sixty two subjects will take part in this study. The study is unic arm. The subjects used the product once and will be evaluated in the regression of pimples in the times 0,4,6,8 and 24 hours after application.
A follow-up visit will be made 24 hours after initiation of treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Benzoyl Peroxide and Sulfur | Experimental | Drug: Benzoyl peroxide and sulfurTopical Medications containing benzoyl peroxide and sulfur |
Who may qualify
- Ages
- 12 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Subjects of both sexes aged to 12 years to 35 years
- Oily skin prone to acne
- Presence of at least three inflammatory lesions, diagnosed as grade II acne vulgaris.
- Sign the informed Consent Form
- Comply the requirements and attend to study visits
Key exclusion criteria (9 listed)
- Pregnancy (need for urinary pregnancy test for women of childbearing age)
- Lactation
- Presence of acne conglobata and nodulocystic
- Pathologies associated hormonal (thyroid diseases, ovaries micropolycystic)
- Drug use systemic corticosteroids, anticonvulsants and / or new drugs for up to one month before to selection.
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 peroxide and sulfurtopical cream, 5% benzoyl peroxide and 2% sulfur Frequency once to day Duration 24 hours | Drug | Benzoyl Peroxide and Sulfur |
Primary outcome
Clinical study to evaluate the efficacy of topical medications containing benzoyl peroxide and sulfur in the regression in the short time (24 hours) of moderate acne vulgaris grade II (pimples).
Time frame: 24 hours
Clinical evolution of the target lesions for each experimental time regarding the parameters of reddening, size and general appearance of the lesion.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2010.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Benzoyl peroxide and sulfur in people with Treatment of Acne Vulgaris Grade II in a Short Period of Time., run by Zurita Laboratorio Farmaceutico Ltda. at 1 site in Brazil.
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 5 inclusion and 9 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 15 Dec 2010. 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 Brazil. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Contact Sergio Schalka, Doctor's ((11) 36816362, medcin@medcinonline.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical study to evaluate the efficacy of topical medications containing benzoyl peroxide and sulfur in the regression in the short time (24 hours) of moderate acne vulgaris grade II (pimples). (time frame: 24 hours). 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 15 Dec 2010.