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

December 14, 2009
March 18, 2010
May 2010
July 2010   (final data collection date for 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 ] [ Designated as safety issue: Yes ]
Measure the efficacy in the treatment of boils or acne vulgaris II and III degree with yam elixir compared with Oxytetracycline. [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01032499 on ClinicalTrials.gov Archive Site
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 ]
Measure the tolerability in the treatment evolution of boils or acne vulgaris II and III with yam elixir compare with Oxytetracycline. [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Open and Comparative Study to Measure Tolerability and Efficacy of Taro Elixir
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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Acne Vulgaris II or III Degree
  • Boils
  • Drug: oxytetracycline, taro elixir
    comparison of treatment efficacy between oxytetracycline and taro elixir
  • Drug: Taro Elixir
    Taken orally one tablespoon (15 mL) of Taro Elixir 3 times daily for breakfast, lunch and dinner.
  • Active Comparator: oxytetracycline
    Intervention: Drug: oxytetracycline, taro elixir
  • Experimental: Taro Elixir
    Taken orally one tablespoon (15 mL) of Taro Elixir 3 times daily for breakfast, lunch and dinner.
    Intervention: Drug: Taro Elixir
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
120
October 2010
July 2010   (final data collection date for primary outcome measure)

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.
Both
14 Years and older
No
Contact: Carlos Machado +55 11 4993-5400 dermatologia@fmabc.br
Contact: Selma Squassoni +55 11 49935459 selma_denis@yahoo.com.br
Brazil
 
NCT01032499
E01-GOU-INH-01-09
Yes
Voltaire Gominho de Oliveira, Laboratorios Goulart S.A.
Laboratorios Goulart S.A.
Not Provided
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
Laboratorios Goulart S.A.
December 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP