Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 1:57 PM
Ignite Modification Date:
2025-12-24 @ 1:57 PM
NCT ID:
NCT01850095
Eligibility Criteria:
Inclusion Criteria:
To all:
1. Signing the consent form before any study procedures;
2. women aged 26 to 44 years, not pregnant and in good health;
3. no topical treatment for acne in the past three months,
4. absence of the use of oral antibiotics in the last 3 months;
5. absence of the use of isotretinoin in the last 2 years;
6. absence of oral contraceptive use in the last 3 months;
7. absence of clinical evidence of immunosuppression and
8. accordance with the conditions of study, ability to understand and strictly follow the instructions given.
For the oral contraceptives group:
1. No contraindications to the use hormonal contraceptives.
For the azelaic acid group:
1. Absence of hypersensitivity to azelaic acid.
Exclusion Criteria:
For all
1. 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;
2. pregnant or lactating women;
3. 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;
4. 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;
5. treatment with oral antibiotics in the past 3 months;
6. acnogenics cosmetics.
For the group treated with oral contraceptives:
1\. Presence of contraindications to oral contraceptive use:
1. Smokers over 35 years;
2. history of deep venous thrombosis;
3. history of stroke;
4. history of breast cancer;
5. presence of jaundice, and severe active liver disease or biliary disease;
6. diabetes mellitus for more than 20 years or eye injury, or neurological impairment;
7. blood pressure greater than or equal to 160 to 100 for systolic and diastolic;
8. cardiovascular disease and
9. presence of severe headache associated with blurred vision frequently.
For the group treated with azelaic acid:
1.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.
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Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
26 Years
Maximum Age:
44 Years
Study:
NCT01850095
Study Brief:
Protocol Section:
NCT01850095