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

NCT01032499 | Unknown Phase 3 DMC

• 1 other identifier: E01-GOU-INH-01-09
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 4

Brief Summary

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

Conditions

Acne Vulgaris II or III Degree; Boils

Keywords

Acne Vulgaris; Boil; Taro Elixir

Outcome Measures

Primary Outcomes (1)

• Measure the efficacy in the treatment of boils or acne vulgaris II and III degree with taro elixir compared with Oxytetracycline.

  90 days

Secondary Outcomes (1)

• Measure the tolerability in the treatment evolution of boils or acne vulgaris II and III with taro elixir compare with Oxytetracycline.

  90 days

Study Arms (2)

oxytetracycline

ACTIVE COMPARATOR

Drug: oxytetracycline, taro elixir

Taro Elixir

EXPERIMENTAL

Taken orally one tablespoon (15 mL) of Taro Elixir 3 times daily for breakfast, lunch and dinner.

Drug: Taro Elixir

Interventions

oxytetracycline, taro elixir DRUG

comparison of treatment efficacy between oxytetracycline and taro elixir

oxytetracycline

Taro Elixir DRUG

Taken orally one tablespoon (15 mL) of Taro Elixir 3 times daily for breakfast, lunch and dinner.

Taro Elixir

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 .

You may not qualify if:

• 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 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.

Sponsors & Collaborators

• Laboratorios Goulart S.A.: lead

Study Sites (4)

Policlínica de Mogi das Cruzes

Mogi das Cruzes, São Paulo, 08780070, Brazil

Location

Faculdade de Medicina do ABC

Santo André, São Paulo, 09060650, Brazil

Location

Alergoclínica - Centro de alergia e dermatologia

São Paulo, São Paulo, 03066030, Brazil

Location

Alergoclínica - Centro de alergia e dermatologia

São Paulo, São Paulo, 04505000, Brazil

Location

MeSH Terms

Conditions

Furunculosis; Acne Vulgaris

Interventions

Oxytetracycline

Condition Hierarchy (Ancestors)

Staphylococcal Skin Infections; Staphylococcal Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Skin Diseases, Bacterial; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases; Fish Diseases; Animal Diseases; Acneiform Eruptions; Sebaceous Gland Diseases

Intervention Hierarchy (Ancestors)

Tetracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Carlos Machado

CONTACT

+55 11 4993-5400; dermatologia@fmabc.br

Selma Squassoni

CONTACT

+55 11 49935459; selma_denis@yahoo.com.br

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: December 14, 2009
• First Posted: December 15, 2009
• Study Start: May 1, 2010
• Primary Completion: July 1, 2010
• Study Completion: October 1, 2010
• Last Updated: March 19, 2010

Record last verified: 2009-12

Locations

BR (4)