Study of New Antiandrogenic Progestogen + Low-dose Estrogen for Moderate Acne Vulgaris

Inclusion Criteria:

1. Ability to confirm voluntary participation and agree to all trial procedures bysigning the Informed Consent Form (ICF) and Informed Assent Form (ITA), ifapplicable, prior to any procedure provided for in the protocol. Note: The adultparticipant or the participant's guardian when the participant is a legal minor (adolescent) must sign the ICF after understanding and agreeing to all trialprocedures. The adolescent participant must provide assent by signing the ITA basedon local regulations and/or guidelines prior to the start of any study procedures.

2. Female sex.

3. Age between 14 and 45 years (inclusive).

4. At least one year after menarche.

5. At least one menstrual period during the last 03 months.

6. Absence of known contraindications for the use of combined oral contraceptives. 7.Diagnosis of moderate acne vulgaris on the face for at least six months,characterized by the presence of:

Note: Information regarding the duration of the disease can be obtained from the clinical history reported by the participant or from a brief medical report of the participant's history, if she is referred from another service.

1. At least 15 inflammatory lesions (papules or pustules);

2. At least 10 non-inflammatory lesions (comedones); and

3. Up to 03 small inactive nodules. Note: Nodules are lesions between 10 and 30 mm,more palpable than visible.

4. Classification ≥ 3 on the 6-point scale of the Investigator's Static GlobalAssessment (ISGA).

5. When the participant did not obtain adequate results with topical treatment,failure or impossibility of systemic treatment with antibiotics (contraindications or intolerance) and the patient has an indication for theuse of antiandrogens and/or isotretinoin.

6. Agreement not to use other topical and/or systemic treatments for acne duringthe study.

Exclusion Criteria:

1. Confirmed or suspected pregnancy. 2. History of childbirth, abortion or lactation inthe last 3 months. 3. Participants who do not agree to use non-hormonalcontraceptive methods permitted during the study, unless they are surgically sterileor who expressly declare themselves to be free from risk of pregnancy because theydo not engage in sexual practices or engage in them in a non-reproductive manner.

2. Current or previous treatment with agents described below with a washout periodshorter than that provided for each:

3. At least 6 months for systemic isotretinoin and/or injectable contraceptive (such asDepo Provera);

4. At least 3 months for implantable contraceptives (such as Implanon) orLevonorgestrel-Releasing Intrauterine System (such as Mirena and Kyleena);

5. At least 2 months for oral contraceptives or other systemic anti-acne agents notmentioned (such as systemic antibiotics);

6. At least 4 weeks for topical retinoids;

7. At least 2 weeks for other topical anti-acne agents (such as topical antibiotics orbenzoyl peroxide); 5. Personal history or first-degree family history of vasculardisease including previous arterial thromboembolic disease (myocardial infarction orstroke), venous thromboembolic disease (peripheral venous thrombosis or pulmonaryembolism) or any condition that increases the risk for any of the previousconditions.

8. Known personal history of thrombophilia. 7. Current smoking. 8. Any disease orcondition that compromises the function of body systems that would result inaltered absorption, excessive accumulation, impaired metabolism or alteredexcretion of the study medication, including malabsorptive conditions (such asprevious bariatric surgery).

9. Any condition that worsens under hormonal treatment or that interferes with theconduct of the study or interpretation of the results, such as gestationalherpes or idiopathic jaundice during previous pregnancy, otosclerosis,Sydeham's chorea, porphyria, bile flow disorders (presence or history ofcholestasis, gallstones, systemic lupus erythematosus).

10. Other comorbidities (history or current diagnosis) such as chronic inflammatorybowel disease (Crohn's disease or ulcerative colitis), hemolytic uremicsyndrome, headache with focal neurological symptoms, epilepsy, asthma withchronic use of oral corticosteroids, multiple sclerosis, Chorea minor, tetany,endometriosis, mastopathy, current premenstrual dysphoric disorder, sickle cellanemia, pancreatitis, vascular complications of diabetes, major depressivedisorder or other conditions that, in the investigator's assessment, maycompromise the participant's safety.

11. Hypersensitivity to any of the components of the experimental drug or placebo.

12. Presence of moderate to severe atopy, acne comedonica or acne conglobata,induced acne or acne with multiple large nodules, cysts, fistular comedones orfistular duct abscess or other dermatological conditions that, in theinvestigator's assessment, may compromise the evaluation of efficacy.

13. Use of comedogenic creams or sunscreens, other preparations with sex hormonesor any other anti-acne therapy (such as phototherapy, oleic acids, chemicalpeeling, mechanical extraction of comedones).

14. Preparations with acnegenic effects, such as iodinated or brominated drugs,tuberculostatics, lithium, vitamins B1 (> 1.5 mg/day), B6 (> 2 mg/day) or B12 (> 6 g/day), corticosteroids, adrenocorticotropic hormone (ACHT), anabolicsteroids, quinine, disulfiram, methoxypsoralen, phenobarbital, phenytoin,trimethadione, thyroid depressants, certain oily cosmetics.

15. History of drug abuse. 16. History of neoplasia in the last 5 years, exceptnon-melanoma skin cancer, or any history of sex hormone-dependent neoplasia orcurrent suspicion of neoplasia, including meningioma.

16. Use of other medications that interfere with hepatic metabolism via cytochromeP450, such as carbamazepine, phenytoin, primidone, oxcarbazepine, topiramate,rifampicin, ritonavir and products containing St. John's wort.

17. Use of direct-acting antiviral medications containing ombitasvir, paritapreviror dasabuvir and combinations of these medications.

18. Undiagnosed vaginal bleeding. 20. Change in clinical breast examination orother clinically significant finding on gynecological examination that could,in the opinion of the investigator, be worsened by oral contraceptives. 21.Absence of proof of a Pap smear (oncotic cytology) without changes suspiciousof malignancy in the last 12 months. Note: If the participant does not have aprevious exam within the accepted interval and agrees, the exam may beperformed at the Selection Visit (VS/V1).

19. Absence of proof of a bilateral mammogram without changes suspicious ofmalignancy in the last 12 months, only for participants aged ≥ 40 years. Note:Mammograms with suspicious of malignancy are considered 23. Obesity (BMI > 30kg/m²). 24. Uncontrolled arterial hypertension (Systolic Blood Pressure [SBP] ≥140 mmHg or Diastolic Blood Pressure [DBP] ≥ 90 mmHg).

20. Participant who has participated in clinical trial protocols in the last 12 (twelve) months, unless the investigator believes that there may be directbenefit to the participant.

21. Participant who, in the opinion of the investigator, presents other clinical orlaboratory conditions or alterations that make him/her unfit to participate inthe study