Open and Comparative Study to Measure Tolerability and Efficacy of Taro Elixir (E01GOU-INH0109)
The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2009 by Laboratorios Goulart S.A..
Recruitment status was Not yet recruiting
Recruitment status was Not yet recruiting
Sponsor:
Laboratorios Goulart S.A.
Information provided by:
Laboratorios Goulart S.A.
ClinicalTrials.gov Identifier:
NCT01032499
First received: December 14, 2009
Last updated: March 18, 2010
Last verified: December 2009
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Purpose
To measure the efficacy of Taro Elixir compare with Oxytetracycline in the treatment of boils or acne.
| Condition | Intervention | Phase |
|---|---|---|
|
Acne Vulgaris II or III Degree Boils |
Drug: oxytetracycline, taro elixir Drug: Taro Elixir |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Laboratorios Goulart S.A.:
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- 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 ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 120 |
| Study Start Date: | May 2010 |
| Estimated Study Completion Date: | October 2010 |
| Estimated Primary Completion Date: | July 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: oxytetracycline |
Drug: oxytetracycline, taro elixir
comparison of treatment efficacy between oxytetracycline and taro elixir
|
|
Experimental: Taro Elixir
Taken orally one tablespoon (15 mL) of Taro Elixir 3 times daily for breakfast, lunch and dinner.
|
Drug: Taro Elixir
Taken orally one tablespoon (15 mL) of Taro Elixir 3 times daily for breakfast, lunch and dinner.
|
Eligibility| Ages Eligible for Study: | 14 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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 .
Exclusion Criteria:
- 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;
- 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01032499
Contacts
| Contact: Carlos Machado | +55 11 4993-5400 | dermatologia@fmabc.br |
| Contact: Selma Squassoni | +55 11 49935459 | selma_denis@yahoo.com.br |
Locations
| Brazil | |
| Policlínica de Mogi das Cruzes | Not yet recruiting |
| Mogi das Cruzes, São Paulo, Brazil, 08780070 | |
| Contact: Denise Steiner +55 11 4728-5383 steiner@uol.com.br | |
| Principal Investigator: Denise Steiner | |
| Faculdade de Medicina do ABC | Not yet recruiting |
| Santo André, São Paulo, Brazil, 09060650 | |
| Contact: Carlos Machado +55 11 4993-5400 dermatologia@fmabc.br | |
| Contact: Selma Squassoni +55 11 49935459 selma_denis@yahoo.com.br | |
| Principal Investigator: Carlos Machado | |
| Alergoclínica - Centro de alergia e dermatologia | Not yet recruiting |
| São Paulo, Brazil, 04505000 | |
| Contact: Andrea Gerbase +55 11 5682-8711 andrea.gerbase@alergoclinica.com.br | |
| Principal Investigator: Andrea Gerbase | |
| Alergoclínica - Centro de alergia e dermatologia | Not yet recruiting |
| São Paulo, Brazil, 03066030 | |
| Contact: Jussara Marin +55 11 2942-1833 jmarin@alergoclinica.com.br | |
| Principal Investigator: Jussara Marin | |
Sponsors and Collaborators
Laboratorios Goulart S.A.
Investigators
| Principal Investigator: | Carlos Machado | Faculdade de Medicina do ABC |
| Principal Investigator: | Andrea Gerbase | Alergoclínica - Centro de Alergia e dermatologia |
| Principal Investigator: | Denise Steiner | Policlínica Mogi das Cruzes |
| Principal Investigator: | Jussara Marin | Alergoclínica - Centro de alergia e dermatologia |
More Information
No publications provided
| Responsible Party: | Voltaire Gominho de Oliveira, Laboratorios Goulart S.A. |
| ClinicalTrials.gov Identifier: | NCT01032499 History of Changes |
| Other Study ID Numbers: | E01-GOU-INH-01-09 |
| Study First Received: | December 14, 2009 |
| Last Updated: | March 18, 2010 |
| Health Authority: | Brazil: National Health Surveillance Agency |
Keywords provided by Laboratorios Goulart S.A.:
|
Acne Vulgaris Boil Taro Elixir |
Additional relevant MeSH terms:
|
Acne Vulgaris Acneiform Eruptions Skin Diseases Facial Dermatoses Sebaceous Gland Diseases |
Oxytetracycline Anti-Bacterial Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 22, 2013