Acne Vulgaris II or III DegreePhase 3E01GOU-INH0109NCT01032499
Open and Comparative Study to Measure Tolerability and Efficacy of Taro Elixir
A Phase 3 study testing oxytetracycline, taro elixir and Taro Elixir in people with Acne Vulgaris II or III Degree and Boils, run by Laboratorios Goulart S.A. at 4 sites in Brazil.
Trial summary
To measure the efficacy of Taro Elixir compare with Oxytetracycline in the treatment of boils or acne. Read more about this study
- Who is it for?
- Ages 14 years and older
- Conditions the study is for
- Acne Vulgaris II or III Degree, Boils
- What is being tested?
- oxytetracycline, taro elixir and Taro Elixir
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 4 sitesBrazil
- Study dates
- May 2010to Oct 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 14 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Both of gender patient, older than 14 years;
- Patient with boils or acne vulgaris II or III degree;
- The score must be at least than 4, for 2 or more question of VAS (visual analog scale);
- Patient that have been used an effective contraceptive method in the last 3 months, including sexual abstinence and that keep using that method during the study until a month after;
- Patient that have been accepted to participate of the study and signed the Informed Consent or in case of younger than 18 years, the responsable must read and sign the Informed Consent.
- Patient that have been accepted to meet all the visits stipulated at the protocol, whenever the investigator request in .
Who cannot join
- Patient of female gender that has been pregnant, breastfeeding or that has not been use a safe contraceptive method (oral contraceptives or barrier methods). Sexual abstinence will be accept if the investigator think that it is relevant.
- Patient that has been use antiandrogens (cyproterone, finasteride, flutamide, tamoxifen, spironolactone);
- Patient with acne I or IV degree;
- Patient that has been receive some treatment for acne as antibiotics, corticosteroid or any medicine that can maybe interfere in the study results: a month for systemic treatment or two weeks for topic treatment, before inclusion or during the study;
- Patient that received treatment with oral retinoids within 6 months before the inclusion and during the study;
- Patient that had a known decompensated diabetes history;
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- Patient with immunodeficiency and liver, renal, cardiac, digestive, metabolic, endocrinological, hematological, neurological or psychiatric disorders, evaluated through anamnesis by the investigator, tha can maybe interfere on the study evaluation. Even the patient with facial dermatoses such as psoriasis, acne rosacea, allergic dermatitis, skin infections caused by fungi, bacteria and viruses;
- Patient with alcoholism history, illicit drugs use, psychological ou emotional problems that can maybe void the Informed Consent or limit the capacity of the patient follow the protocol requirements ;
- Patient hypersensitive to any one of the medicine components;
- Patient that have been used any drug under search, 3 months before the visit number one.
Trial locations and contacts
4 sites in 1 country.
Brazil4 sites
Policlínica de Mogi das Cruzes
Mogi das Cruzes, São Paulo, 08780070
Denise Steiner, +55 11 4728-5383, steiner@uol.com.br
Denise Steiner
Faculdade de Medicina do ABC
Santo André, São Paulo, 09060650
Carlos Machado, +55 11 4993-5400, dermatologia@fmabc.br
Selma Squassoni, +55 11 49935459, selma_denis@yahoo.com.br
Alergoclínica - Centro de alergia e dermatologia
São Paulo, São Paulo, 03066030
Jussara Marin, +55 11 2942-1833, jmarin@alergoclinica.com.br
Jussara Marin
Alergoclínica - Centro de alergia e dermatologia
São Paulo, São Paulo, 04505000
Andrea Gerbase, +55 11 5682-8711, andrea.gerbase@alergoclinica.com.br
Andrea Gerbase
About this study
Official title: Multicenter Clinical Study,Phase III, Prospective, Randomized, Open and Comparative to Measure Tolerability and Efficacy of Taro Elixir on the Evolution Treatment of Acne Vulgaris II and III Degree or of Furunculosis Compared With Oxytetracycline
To measure the efficacy of Taro Elixir compare with Oxytetracycline in the treatment of boils or acne.
- Conditions
- Acne Vulgaris II or III Degree, Boils
- Being tested
- oxytetracycline, taro elixir, Taro Elixir
- Keywords
- Acne Vulgaris, Boil, Taro Elixir
- Medical subject headings
- Furunculosis, Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oxytetracycline, taro elixirDrug
comparison of treatment efficacy between oxytetracycline and taro elixir
Taro ElixirDrug
Taken orally one tablespoon (15 mL) of Taro Elixir 3 times daily for breakfast, lunch and dinner.
| Study group | Role | What they receive |
|---|---|---|
| oxytetracycline | Active comparator | Not described Receives: Drug: oxytetracycline, taro elixir |
| Taro Elixir | Experimental | Taken orally one tablespoon (15 mL) of Taro Elixir 3 times daily for breakfast, lunch and dinner. Receives: Drug: Taro Elixir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure the efficacy in the treatment of boils or acne vulgaris II and III degree with taro elixir compared with Oxytetracycline.
Measured: 90 days
Secondary outcomes (1)
Measure the tolerability in the treatment evolution of boils or acne vulgaris II and III with taro elixir compare with Oxytetracycline.
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2009 (estimated)
- Study startMay 2010
- Primary completionJul 2010 (estimated)
- Study completionOct 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acne Vulgaris II or III DegreeStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Laboratorios Goulart S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Carlos Machado, Principal investigator, Faculdade de Medicina do ABCAndrea Gerbase, Principal investigator, Alergoclínica - Centro de Alergia e dermatologiaDenise Steiner, Principal investigator, Policlínica Mogi das CruzesJussara Marin, Principal investigator, Alergoclínica - Centro de alergia e dermatologia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01032499
- Sponsor's protocol ID
- E01-GOU-INH-01-09
- Acronym
- E01GOU-INH0109
- Status last verified
- Dec 2009
- First submitted
- 14 Dec 2009
- Last updated
- 19 Mar 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Clinical Study,Phase III, Prospective, Randomized, Open and Comparative to Measure Tolerability and Efficacy of Taro Elixir on the Evolution Treatment of Acne Vulgaris II and III Degree or of Furunculosis Compared With Oxytetracycline
- ClinicalTrials.gov ID
- NCT01032499
- Acronym / sponsor ID
- E01GOU-INH0109 / E01-GOU-INH-01-09
- Conditions
- Acne Vulgaris II or III Degree, Boils
- Keywords
- Acne Vulgaris, Boil, Taro Elixir
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Laboratorios Goulart S.A.Industry (pharma, biotech, devices)
- Study start
- May 2010
- Primary completion
- Jul 2010 (estimated)
- Study completion
- Oct 2010 (estimated)
- First posted
- 15 Dec 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.
To measure the efficacy of Taro Elixir compare with Oxytetracycline in the treatment of boils or acne.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| oxytetracycline | Active comparator | Drug: oxytetracycline, taro elixir |
| Taro Elixir | Experimental | Drug: Taro ElixirTaken orally one tablespoon (15 mL) of Taro Elixir 3 times daily for breakfast, lunch and dinner. |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Both of gender patient, older than 14 years;
- Patient with boils or acne vulgaris II or III degree;
- The score must be at least than 4, for 2 or more question of VAS (visual analog scale);
- Patient that have been used an effective contraceptive method in the last 3 months, including sexual abstinence and that keep using that method during the study until a month after;
- Patient that have been accepted to participate of the study and signed the Informed Consent or in case of younger than 18 years, the responsable must read and sign the Informed Consent.
Key exclusion criteria (10 listed)
- Patient of female gender that has been pregnant, breastfeeding or that has not been use a safe contraceptive method (oral contraceptives or barrier methods). Sexual abstinence will be accept if the investigator think that it is relevant.
- Patient that has been use antiandrogens (cyproterone, finasteride, flutamide, tamoxifen, spironolactone);
- Patient with acne I or IV degree;
- Patient that has been receive some treatment for acne as antibiotics, corticosteroid or any medicine that can maybe interfere in the study results: a month for systemic treatment or two weeks for topic treatment, before inclusion or during the study;
- Patient that received treatment with oral retinoids within 6 months before the inclusion and during the study;
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 |
|---|---|---|
| oxytetracycline, taro elixircomparison of treatment efficacy between oxytetracycline and taro elixir | Drug | oxytetracycline |
| Taro ElixirTaken orally one tablespoon (15 mL) of Taro Elixir 3 times daily for breakfast, lunch and dinner. | Drug | Taro Elixir |
Primary outcome
Measure the efficacy in the treatment of boils or acne vulgaris II and III degree with taro elixir compared with Oxytetracycline.
Time frame: 90 days
1 secondary outcome
Measure the tolerability in the treatment evolution of boils or acne vulgaris II and III with taro elixir compare with Oxytetracycline.
Time frame: 90 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 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.
Carlos Machado principal investigator
Faculdade de Medicina do ABC
Andrea Gerbase principal investigator
Alergoclínica - Centro de Alergia e dermatologia
Denise Steiner principal investigator
Policlínica Mogi das Cruzes
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing oxytetracycline, taro elixir and Taro Elixir in people with Acne Vulgaris II or III Degree and Boils, run by Laboratorios Goulart S.A. at 4 sites 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 6 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 19 Mar 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Carlos Machado (+55 11 4993-5400, dermatologia@fmabc.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure the efficacy in the treatment of boils or acne vulgaris II and III degree with taro elixir compared with Oxytetracycline. (time frame: 90 days). 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 19 Mar 2010.