Acne Vulgaris II or III Degree, Boils
Conditions
Keywords
Acne Vulgaris, Boil, Taro Elixir
Brief summary
To measure the efficacy of Taro Elixir compare with Oxytetracycline in the treatment of boils or acne.
Interventions
DRUGoxytetracycline, taro elixir
comparison of treatment efficacy between oxytetracycline and taro elixir
DRUGTaro Elixir
Taken orally one tablespoon (15 mL) of Taro Elixir 3 times daily for breakfast, lunch and dinner.
Sponsors
Laboratorios Goulart S.A.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
14 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| 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
| 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 |
Countries
Brazil
Contacts
Primary ContactCarlos Machado
Backup ContactSelma Squassoni
Outcome results
None listed