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临床试验/RBR-7ddb5s
RBR-7ddb5s尚未招募4 期

Contribution to the study of acne in adult women: analysis of the correlation between peripheral androgen conversion and its influence on the expression of toll-like receptors 2 and CD1d in areas with and without inflammatory acne lesions and its modulation by treatment with oral contraceptive or topical cream with anti-androgen activity.

IFESP-EPM0 个研究点开始时间: 2013年8月13日最近更新:
适应症

试验速览

阶段
4 期
状态
尚未招募
发起方

研究概览

简要总结

暂无简介。

研究设计

研究类型
Intervention

入排标准

年龄范围
26Y 至 44Y(—)
性别
Female

入选标准

  • Signing the consent form before any study procedures;
  • women aged 26-44 years, not pregnant and in good health;
  • no topical treatment for acne in the last three months, except sanitizers;
  • Lack of use of oral antibiotics in the last 3 months;
  • Absence of the use of isotretinoin in the last two years;
  • Absence of oral contraceptive use in the last 3 months;
  • Absence of clinical evidence of immunosuppression and
  • accordance with the conditions of study, ability to understand and strictly follow the instructions received.
  • For the group treated with oral contraceptives:
  • Absence of contraindications to the use of hormonal contraceptives.
  • For the group treated with azelaic acid:
  • Absence of skin hypersensitivity to azelaic acid.

排除标准

  • Women who do not agree with the conditions of the study or without the ability to understand and strictly follow the advice they had received no willingness to attend the revaluations or refuse to sign the Informed Consent;
  • Pregnant or lactating women;
  • Use the following oral medications: cortisone derivatives, lithium, anticonvulsants, isoniazid, oral contraceptives, androgens, danazol, iodides, bromides, disulfiram, cyclosporine, azathioprine, tiuréias, vitamins B2, B6 and B12;
  • Treatment of facial skin with topical retinoids (tretinoin and adapalene), azelaic acid, benzoyl peroxide, clindamycin, erythromycin, nicotinamina, singly or in combination, in the last 3 months;
  • Treatment with oral antibiotics in the last 3 months;
  • Use of cosmetics acnogênicos;
  • Presence of contraindications to oral contraceptive use (smoker over 35 years;
  • history of deep venous thrombosis, history of stroke, history of breast cancer, presence of jaundice, and severe active liver disease or biliary disease;
  • diabetes mellitus for more than 20 years or eye injury, neurological or renal arterial pressure greater than or equal to 160 to 100 for systolic and diastolic;
  • cardiovascular disease and the presence of severe headache associated with blurred vision often) for the group treated with oral contraceptive;
  • Presence of allergic symptoms and / or irritating to the use of azelaic acid for the group treated with azelaic acid;
  • History, clinical signs and / or laboratory hyperandrogenism prior to a control group;
  • Presence of inflammatory acne on the face for the control group 2.

研究者

发起方
IFESP-EPM

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