Open and Comparative Study to Measure Tolerability and Efficacy of Taro Elixir

Boils Clinical Trial

— E01GOU-INH0109  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01032499
• Other study ID #: E01-GOU-INH-01-09
• Status: Not yet recruiting
• Phase: Phase 3
• First received: December 14, 2009
• Last updated: March 18, 2010
• Start date: May 2010
• Est. completion date: October 2010

Study information

• Verified date: December 2009
• Source: Laboratorios Goulart S.A.
• Contact: Carlos Machado
• Phone: +55 11 4993-5400
• Email: dermatologia[@]fmabc.br
• Is FDA regulated: No
• Health authority: Brazil: National Health Surveillance Agency
• Study type: Interventional

Clinical Trial Summary

To measure the efficacy of Taro Elixir compare with Oxytetracycline in the treatment of boils or acne.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: October 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 14 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acne Vulgaris
• Acne Vulgaris II or III Degree
• Boils

Intervention

Drug:
• oxytetracycline, taro elixir
comparison of treatment efficacy between oxytetracycline and taro elixir
• Taro Elixir
Taken orally one tablespoon (15 mL) of Taro Elixir 3 times daily for breakfast, lunch and dinner.

Locations

Country	Name	City	State
Brazil	Policlínica de Mogi das Cruzes	Mogi das Cruzes	São Paulo
Brazil	Faculdade de Medicina do ABC	Santo André	São Paulo
Brazil	Alergoclínica - Centro de alergia e dermatologia	São Paulo
Brazil	Alergoclínica - Centro de alergia e dermatologia	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Laboratorios Goulart S.A.

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measure the efficacy in the treatment of boils or acne vulgaris II and III degree with taro elixir compared with Oxytetracycline.		90 days	Yes
Secondary	Measure the tolerability in the treatment evolution of boils or acne vulgaris II and III with taro elixir compare with Oxytetracycline.		90 days	Yes