Evaluation of hormonal acne in adult women and its treatment with two different therapies.

Phase 4

• Conditions: acne; I01.800

• Registration Number: RBR-7ddb5s
• Lead Sponsor: IFESP-EPM

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-08-13
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

To all:

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.

Exclusion Criteria

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.

Study & Design

• Study Type: Intervention
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Reduction of acne after treatment with the drugs according to clinical evaluation of acne and photo before and after 6 months of treatment.;Decreased expression of the receptors TLR2 after treatment with drugs, in accordance with the immunohistochemical analysis before and after 6 months of treatment and their relationship to the control group.;Increase in CD1d receptor expression following treatment with the drugs in accordance with the immunohistochemical analysis before and after 6 months of treatment and their relationship to the control group.;<br>Reduction in the dosage of androgen with the metabolic drugs, according to analysis by liquid chromatography before and after 6 months of treatment and their relationship to the control group.

Secondary Outcome Measures

Name	Time	Method
Improved quality of life evaluated by comparing the quality of life questionnaire before and after in acne treatment.