Acne Vulgaris II or III Degree | Open and Comparative Study to Measure Tolerability and Efficacy of Taro Elixir
Acne Vulgaris II or III Degree research study
What is the primary objective of this study?
To measure the efficacy of Taro Elixir compare with Oxytetracycline in the treatment of boils or acne.
Who is eligible to participate?
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.
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Acne Vulgaris II or III Degree
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:oxytetracycline, taro elixircomparison of treatment efficacy between oxytetracycline and taro elixir
Drug:Taro ElixirTaken orally one tablespoon (15 mL) of Taro Elixir 3 times daily for breakfast, lunch and dinner.
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Taro ElixirTaken orally one tablespoon (15 mL) of Taro Elixir 3 times daily for breakfast, lunch and dinner.
Start Date: May 2010
Completed Date: October 2010
Phase: Phase 3
Primary Outcome: Measure the efficacy in the treatment of boils or acne vulgaris II and III degree with taro elixir compared with Oxytetracycline.
Secondary Outcome: Measure the tolerability in the treatment evolution of boils or acne vulgaris II and III with taro elixir compare with Oxytetracycline.
Study sponsors, principal investigator, and references
Principal Investigator: Carlos Machado
Lead Sponsor: Laboratorios Goulart S.A.