Open and Comparative Study to Measure Tolerability and Efficacy of Taro Elixir (E01GOU-INH0109)

L

Laboratorios Goulart S.A.

Status and phase

Unknown
Phase 3

Conditions

Acne Vulgaris II or III Degree
Boils

Treatments

Drug: Taro Elixir
Drug: oxytetracycline, taro elixir

Study type

Interventional

Funder types

Industry

Identifiers

NCT01032499
E01-GOU-INH-01-09

Details and patient eligibility

About

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

Enrollment

120 estimated patients

Sex

All

Ages

14+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

120 participants in 2 patient groups

oxytetracycline
Active Comparator group
Treatment:
Drug: oxytetracycline, taro elixir
Taro Elixir
Experimental group
Description:
Taken orally one tablespoon (15 mL) of Taro Elixir 3 times daily for breakfast, lunch and dinner.
Treatment:
Drug: Taro Elixir

Trial contacts and locations

4

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Central trial contact

Selma Squassoni; Carlos Machado

Data sourced from clinicaltrials.gov

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