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
Sponsor:
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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 20, 2014