Status:
UNKNOWN
The Influence of Peripheral Androgen Conversion at Women Adult Acne
Lead Sponsor:
Marco Alexandre Dias da Rocha
Collaborating Sponsors:
Fleury
Associacao Fundo de Incentivo a Psicofarmcologia
Conditions:
Acne
Quality of Life
Eligibility:
FEMALE
26-44 years
Phase:
NA
Brief Summary
Acne vulgaris is a chronic inflammatory disease that affects the pilosebaceous unit. Recent studies have demonstrated an increase number of acne cases in adult women. These cases are predominantly nor...
Eligibility Criteria
Inclusion
- To all:
- Signing the consent form before any study procedures;
- women aged 26 to 44 years, not pregnant and in good health;
- no topical treatment for acne in the past three months,
- absence of the use of oral antibiotics in the last 3 months;
- absence of the use of isotretinoin in the last 2 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 given.
- For the oral contraceptives group:
- No contraindications to the use hormonal contraceptives.
- For the azelaic acid group:
- Absence of hypersensitivity to azelaic acid.
Exclusion
- For all
- Women who do not agree with the conditions of the study or without the ability to understand and closely follow the guidelines received without availability to attend the revaluations or who refuse to sign the Informed Consent Form;
- pregnant or lactating women;
- use of the following oral medications: cortisone derivatives, lithium, anticonvulsants, isoniazid, oral contraceptives, androgens, danazol, iodides, bromides, disulfiram, cyclosporine, azathioprine, thiuram, vitamins B2, B6 and B12;
- treatment of facial skin with topical retinoids (tretinoin and adapalene), azelaic acid, benzoyl peroxide, clindamycin, erythromycin, nicotinamina, alone or in combination, in the past 3 months;
- treatment with oral antibiotics in the past 3 months;
- acnogenics cosmetics.
- For the group treated with oral contraceptives:
- 1\. Presence of contraindications to oral contraceptive use:
- Smokers 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, or neurological impairment;
- blood pressure greater than or equal to 160 to 100 for systolic and diastolic;
- cardiovascular disease and
- presence of severe headache associated with blurred vision frequently.
- For the group treated with azelaic acid:
- Presense of allergic and / or irritating symptoms to the use of azelaic acid.
- For the control group 1:
- 1\. History, clinical signs and / or laboratory evidence of hyperandrogenism. 2 .Presence of inflammatory acne.
- \-
Key Trial Info
Start Date :
March 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2015
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT01850095
Start Date
March 1 2012
End Date
January 1 2015
Last Update
May 9 2013
Active Locations (1)
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1
Federal University of São Paulo-Dermatology
São Paulo, São Paulo, Brazil, 04038-001