Acne VulgarisPhase 3NCT00838812
Safety and Efficacy Study of Association Between Tretinoin and Clindamycin on the Treatment of Acne Mild and Moderate
A Phase 3 study testing application of the topic gel in people with Acne Vulgaris, run by Igefarma Laboratorios S.A. at 1 site in Brazil.
Trial summary
The purpose of this study is to determine the safety and efficacy of association between tretinoin and clindamycin phosphate on the treatment of acne vulgaris mild and moderate. Read more about this study
- Who is it for?
- Ages 12 years and olderHealthy volunteers can take part
- Conditions the study is for
- Acne Vulgaris
- What is being tested?
- application of the topic gel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 154 participants
- Where
- 1 siteBrazil
- Study dates
- Mar 2009to Apr 2010
- 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 12 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Individuals of both sexes with age greater than or equal to 12 years
- Subjects diagnosed with acne vulgaris in the face, except for the nasal area, range from mild to moderate, with the following requirements.
- Mild acne = presence of fewer than 20 comedones or less than 15 lesions, inflammatory lesions or a total of less than 30 injuries.
- Moderate acne = presence of 20 the 100 comedones or of 15 the 50 inflamatory lesions or a total of 30 the 125 lesions, with not more than lesions small nodule until 5,0 mm.
- Ensure that the existing injuries were not submitted any treatment for acne, topical or systemic, within the last 30 days.
- Be able to properly follow the determinations of the Protocol.
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- Has provided a written voluntary consent to participate in the study, by signing the informed consent, before being subjected to any procedure.
- Under 18 years old, be accompanied by legal guardian in the process of obtaining the informed consent.
- Be mentally able to provide consent and be fulfilling all the requirements of the study.
Who cannot join
- Pregnant women or in periods of lactation.
- Women of childbearing age and sexual activity with not using safe contraceptive method, such as oral contraceptives, implantable, injectable or intra-uterine, introduced for at least 120 days.
- Women who are using oral contraceptives containing the hormone combination for acetate ciprosterone and etinolestradiol, association of drospirenone and ethinyl estradiol, or desogestrel.
- Clinical evidence or history of immunodeficiency.
- Any use of immunosuppressive drug and/or immunomodulating over the past 3 months, topical or systemic.
- Concurrent use of fotossentetizadores, neuromuscular blockers, medications that exacerbate the acne, blockers (filters) with solar alcoholic vehicle, spironolactone, flutamide or zinc salts.
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- Prior use of systemic retinoid.
- Presence of acne medication and/or cosmetic.
- History of systemic metabolic disorder that can interfere with the integrity of the skin.
- History of inflammatory disease, intestinal or regional enteritis and/or symptoms similar.
- History of joy to any of the components of the formula (active principle or carrier).
- History of abuse of alcohol and/or illegal drugs.
- History of non-adherence to medical treatment earlier.
- Any clinical observation made by the investigator that prohibits participation in the study of the subject.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Monocentric Study, Prospective, Open and Non Controlled for to Evaluate the Effectiveness, and Tolerability the Safety of Association of Clindamycin Phosphate 1.2% and Tretinoin 0,025% in the Treatment of Acne Vulgaris Mild to Moderate, When Used Once Daily for 12 Weeks.
The purpose of this study is to determine the safety and efficacy of association between tretinoin and clindamycin phosphate on the treatment of acne vulgaris mild and moderate.
- Conditions
- Acne Vulgaris
- Being tested
- application of the topic gel
- Keywords
- clindamycin, tretinoin, acne vulgaris, Acne vulgaris mild to moderate
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
application of the topic gelDrug
Clindamycin Phosphate 1,2% and tretinoin 0,025% gel once daily at night 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| clindamicin and tretinoin gel | Other | Not described Receives: Drug: application of the topic gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the efficacy, through number of lesions, and tolerability of the product.
Measured: three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2009 (estimated)
- Study startMar 2009
- Primary completionJan 2010
- Study completionApr 2010
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.
- 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 154 participants (actual)
Sponsor and investigators
- Lead sponsor
- Igefarma Laboratorios S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00838812
- Sponsor's protocol ID
- IGF 03-42008
- Status last verified
- May 2010
- First submitted
- 5 Feb 2009
- Last updated
- 25 May 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monocentric Study, Prospective, Open and Non Controlled for to Evaluate the Effectiveness, and Tolerability the Safety of Association of Clindamycin Phosphate 1.2% and Tretinoin 0,025% in the Treatment of Acne Vulgaris Mild to Moderate, When Used Once Daily for 12 Weeks.
- ClinicalTrials.gov ID
- NCT00838812
- Acronym / sponsor ID
- IGF 03-42008
- Conditions
- Acne Vulgaris
- Keywords
- clindamycin, tretinoin, acne vulgaris, Acne vulgaris mild to moderate
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 154 participants (actual)
- Lead sponsor
- Igefarma Laboratorios S.A.Industry (pharma, biotech, devices)
- Study start
- Mar 2009
- Primary completion
- Jan 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 6 Feb 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 the safety and efficacy of association between tretinoin and clindamycin phosphate on the treatment of acne vulgaris mild and moderate.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| clindamicin and tretinoin gel | Other | Drug: application of the topic gel |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- Individuals of both sexes with age greater than or equal to 12 years
- Subjects diagnosed with acne vulgaris in the face, except for the nasal area, range from mild to moderate, with the following requirements.
- Ensure that the existing injuries were not submitted any treatment for acne, topical or systemic, within the last 30 days.
- Be able to properly follow the determinations of the Protocol.
- Has provided a written voluntary consent to participate in the study, by signing the informed consent, before being subjected to any procedure.
Key exclusion criteria (14 listed)
- Pregnant women or in periods of lactation.
- Women of childbearing age and sexual activity with not using safe contraceptive method, such as oral contraceptives, implantable, injectable or intra-uterine, introduced for at least 120 days.
- Women who are using oral contraceptives containing the hormone combination for acetate ciprosterone and etinolestradiol, association of drospirenone and ethinyl estradiol, or desogestrel.
- Clinical evidence or history of immunodeficiency.
- Any use of immunosuppressive drug and/or immunomodulating over the past 3 months, topical or systemic.
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 |
|---|---|---|
| application of the topic gelClindamycin Phosphate 1,2% and tretinoin 0,025% gel once daily at night 12 weeks. | Drug | clindamicin and tretinoin gel |
Primary outcome
Evaluation of the efficacy, through number of lesions, and tolerability of the product.
Time frame: three months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2010.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 application of the topic gel in people with Acne Vulgaris, run by Igefarma Laboratorios S.A. 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 9 inclusion and 14 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: finished, as of the sponsor's last update on 25 May 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 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Evaluation of the efficacy, through number of lesions, and tolerability of the product. (time frame: three 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 25 May 2010.