Clinical trial NCT01032499: Open and Comparative Study to Measure Tolerability and Efficacy of Taro Elixir
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Acne Vulgaris II or III Degree
Boils
Keywords: Acne Vulgaris
Boil
Taro Elixir
Lead sponsor: Laboratorios Goulart S.A.
Sponsor class: INDUSTRY
First posted: 2009-12-15
Enrollment: 120
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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.

Primary outcomes:
measure: Measure the efficacy in the treatment of boils or acne vulgaris II and III degree with taro elixir compared with Oxytetracycline.
timeFrame: 90 days
Secondary outcomes:
measure: Measure the tolerability in the treatment evolution of boils or acne vulgaris II and III with taro elixir compare with Oxytetracycline.
timeFrame: 90 days
Other outcomes:
Locations:
city: Mogi das Cruzes
country: Brazil
facility: Policlínica de Mogi das Cruzes
state: São Paulo
city: Santo André
country: Brazil
facility: Faculdade de Medicina do ABC
state: São Paulo
city: São Paulo
country: Brazil
facility: Alergoclínica - Centro de alergia e dermatologia
city: São Paulo
country: Brazil
facility: Alergoclínica - Centro de alergia e dermatologia
Study officials:
affiliation: Faculdade de Medicina do ABC
name: Carlos Machado
role: PRINCIPAL_INVESTIGATOR
affiliation: Alergoclínica - Centro de Alergia e dermatologia
name: Andrea Gerbase
role: PRINCIPAL_INVESTIGATOR
affiliation: Policlínica Mogi das Cruzes
name: Denise Steiner
role: PRINCIPAL_INVESTIGATOR
affiliation: Alergoclínica - Centro de alergia e dermatologia
name: Jussara Marin
role: PRINCIPAL_INVESTIGATOR
References: