Open and Comparative Study to Measure Tolerability and Efficacy of Taro Elixir (NCT01032499) | Clinical Trial Compass
UnknownPhase 3
Open and Comparative Study to Measure Tolerability and Efficacy of Taro Elixir
Brazil120 participantsStarted 2010-05
Plain-language summary
To measure the efficacy of Taro Elixir compare with Oxytetracycline in the treatment of boils or acne.
Who can participate
Age range14 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
What they're measuring
1
Measure the efficacy in the treatment of boils or acne vulgaris II and III degree with taro elixir compared with Oxytetracycline.