Open and Comparative Study to Measure Tolerability and Efficacy of Taro Elixir (E01GOU-INH0109)

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.

Study Overview

• Status: Unknown
• Conditions: Boils; Acne Vulgaris II or III Degree
• Intervention / Treatment: Drug: oxytetracycline, taro elixir; Drug: Taro Elixir

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Phase 3

Contacts and Locations

Study Locations

• Brazil
  • São Paulo, Brazil, 03066030
    • Alergoclínica - Centro de alergia e dermatologia
  • São Paulo, Brazil, 04505000
    • Alergoclínica - Centro de alergia e dermatologia
  • São Paulo
    • Mogi das Cruzes, São Paulo, Brazil, 08780070
      • Policlínica de Mogi das Cruzes
    • Santo André, São Paulo, Brazil, 09060650
      • Faculdade de Medicina do ABC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Measure the efficacy in the treatment of boils or acne vulgaris II and III degree with taro elixir compared with Oxytetracycline.	90 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Measure the tolerability in the treatment evolution of boils or acne vulgaris II and III with taro elixir compare with Oxytetracycline.	90 days

Collaborators and Investigators

• Sponsor: 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

Study record dates

Study Major Dates

• Study Start: May 1, 2010
• Primary Completion (Anticipated): July 1, 2010
• Study Completion (Anticipated): October 1, 2010

Study Registration Dates

• First Submitted: December 14, 2009
• First Submitted That Met QC Criteria: December 14, 2009
• First Posted (Estimate): December 15, 2009

Study Record Updates

• Last Update Posted (Estimate): March 19, 2010
• Last Update Submitted That Met QC Criteria: March 18, 2010
• Last Verified: December 1, 2009

More Information

Terms related to this study

• Keywords: Acne Vulgaris; Boil; Taro Elixir
• Additional Relevant MeSH Terms: Skin Diseases; Acneiform Eruptions; Sebaceous Gland Diseases; Acne Vulgaris; Anti-Infective Agents; Anti-Bacterial Agents; Oxytetracycline
• Other Study ID Numbers: E01-GOU-INH-01-09