Acne VulgarisPhase 3PANDORANCT06905210
Study of New Antiandrogenic Progestogen + Low-dose Estrogen for Moderate Acne Vulgaris
A Phase 3 study testing Experimental drug (Cyproterone Acetate 2 mg and Ethinyl Estradiol 0.02 mg) in people with Acne Vulgaris and Acne Vulgaris on the Face, run by Eurofarma Laboratorios S.A. at 18 sites in Brazil.
Trial summary
This Phase III randomized, double-blind, placebo-controlled, adaptive, multicenter study evaluates the efficacy and safety of a new concentration of the fixed-dose combination EF190 in women with moderate acne vulgaris over six 28-day treatment cycles. Read more about this study
- Who is it for?
- Ages 14 to 45 years, women only
- Conditions the study is for
- Acne Vulgaris, Acne Vulgaris on the Face
- What is being tested?
- Experimental drug (Cyproterone Acetate 2 mg and Ethinyl Estradiol 0.02 mg)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 531 participants
- Where
- 18 sitesBrazil
- Study dates
- 24 Aug 2026to Mar 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 45 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- Ability to confirm voluntary participation and agree to all trial procedures by signing the Informed Consent Form (ICF) and Informed Assent Form (ITA), if applicable, prior to any procedure provided for in the protocol. Note: The adult participant or the participant's guardian when the participant is a legal minor (adolescent) must sign the ICF after understanding and agreeing to all trial procedures. The adolescent participant must provide assent by signing the ITA based on local regulations and/or guidelines prior to the start of any study procedures.
- Female sex.
- Age between 14 and 45 years (inclusive).
- At least one year after menarche.
- At least one menstrual period during the last 03 months.
- 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:
Show all 13Show fewer
- 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.
- At least 15 inflammatory lesions (papules or pustules);
- At least 10 non-inflammatory lesions (comedones); and
- Up to 03 small inactive nodules. Note: Nodules are lesions between 10 and 30 mm, more palpable than visible.
- 8. Classification ≥ 3 on the 6-point scale of the Investigator's Static Global Assessment (ISGA).
- 9. 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 the use of antiandrogens and/or isotretinoin.
- 10. Agreement not to use other topical and/or systemic treatments for acne during the study.
Who cannot join
- 1. Confirmed or suspected pregnancy. 2. History of childbirth, abortion or lactation in the last 3 months. 3. Participants who do not agree to use non-hormonal contraceptive methods permitted during the study, unless they are surgically sterile or who expressly declare themselves to be free from risk of pregnancy because they do not engage in sexual practices or engage in them in a non-reproductive manner.
- 4. Current or previous treatment with agents described below with a washout period shorter than that provided for each:
- At least 6 months for systemic isotretinoin and/or injectable contraceptive (such as Depo Provera);
- At least 3 months for implantable contraceptives (such as Implanon) or Levonorgestrel-Releasing Intrauterine System (such as Mirena and Kyleena);
- At least 2 months for oral contraceptives or other systemic anti-acne agents not mentioned (such as systemic antibiotics);
- At least 4 weeks for topical retinoids;
Show all 21Show fewer
- At least 2 weeks for other topical anti-acne agents (such as topical antibiotics or benzoyl peroxide); 5. Personal history or first-degree family history of vascular disease including previous arterial thromboembolic disease (myocardial infarction or stroke), venous thromboembolic disease (peripheral venous thrombosis or pulmonary embolism) or any condition that increases the risk for any of the previous conditions.
- 6. Known personal history of thrombophilia. 7. Current smoking. 8. Any disease or condition that compromises the function of body systems that would result in altered absorption, excessive accumulation, impaired metabolism or altered excretion of the study medication, including malabsorptive conditions (such as previous bariatric surgery).
- 9. Any condition that worsens under hormonal treatment or that interferes with the conduct of the study or interpretation of the results, such as gestational herpes or idiopathic jaundice during previous pregnancy, otosclerosis, Sydeham's chorea, porphyria, bile flow disorders (presence or history of cholestasis, gallstones, systemic lupus erythematosus).
- 10. Other comorbidities (history or current diagnosis) such as chronic inflammatory bowel disease (Crohn's disease or ulcerative colitis), hemolytic uremic syndrome, headache with focal neurological symptoms, epilepsy, asthma with chronic use of oral corticosteroids, multiple sclerosis, Chorea minor, tetany, endometriosis, mastopathy, current premenstrual dysphoric disorder, sickle cell anemia, pancreatitis, vascular complications of diabetes, major depressive disorder or other conditions that, in the investigator's assessment, may compromise 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 or fistular duct abscess or other dermatological conditions that, in the investigator's assessment, may compromise the evaluation of efficacy.
- 13. Use of comedogenic creams or sunscreens, other preparations with sex hormones or any other anti-acne therapy (such as phototherapy, oleic acids, chemical peeling, 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), anabolic steroids, 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, except non-melanoma skin cancer, or any history of sex hormone-dependent neoplasia or current suspicion of neoplasia, including meningioma.
- 17. Use of other medications that interfere with hepatic metabolism via cytochrome P450, such as carbamazepine, phenytoin, primidone, oxcarbazepine, topiramate, rifampicin, ritonavir and products containing St. John's wort.
- 18. Use of direct-acting antiviral medications containing ombitasvir, paritaprevir or dasabuvir and combinations of these medications.
- 19. Undiagnosed vaginal bleeding. 20. Change in clinical breast examination or other 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 suspicious of malignancy in the last 12 months. Note: If the participant does not have a previous exam within the accepted interval and agrees, the exam may be performed at the Selection Visit (VS/V1).
- 22. Absence of proof of a bilateral mammogram without changes suspicious of malignancy in the last 12 months, only for participants aged ≥ 40 years. Note: Mammograms with suspicious of malignancy are considered 23. Obesity (BMI > 30 kg/m²). 24. Uncontrolled arterial hypertension (Systolic Blood Pressure [SBP] ≥140 mmHg or Diastolic Blood Pressure [DBP] ≥ 90 mmHg).
- 25. Participant who has participated in clinical trial protocols in the last 12 (twelve) months, unless the investigator believes that there may be direct benefit to the participant.
- 26. Participant who, in the opinion of the investigator, presents other clinical or laboratory conditions or alterations that make him/her unfit to participate in the study
Trial locations and contacts
18 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Taís Mendonça dos Santos contact
18 sites in 1 country
Brazil18 sites, 18 recruiting
- Recruiting
Norte Pesquisa Clínica
Belém, Pará, 66093-681
+55 91 98251-0454
- Recruiting
Hospital Universitário São Francisco na Providência de Deus - HUSF
Bragança Paulista, São Paulo, 12.916-542
+55 11 2490-1130
- Recruiting
Instituto de Gestão Estratégica de Saúde do Distrito Federal-IGESDF
Brasília, Federal District, 70335-902
+55 61 98311-2895
- Recruiting
CLINICA GERAL INVESTIGA LTDA (Allergisa)
Campinas, São Paulo, 12916-900
+55 19 99778-0204
- Recruiting
Synvia
Campinas, São Paulo, 13086-045
+55 19 99933-1385
- Recruiting
ICF Ciências Farmacêutica - Unidade Clínica
Goiânia, Goiás, 74.935-530
+55 62 99963-6770
- Recruiting
Centro de Pesquisa Clínica - Hospital Ruy Azeredo
Goiânia, Goiás, 74453-200
+55 11 98764-3924
- Recruiting
Eurofarma Laboratórios S.A
Itapevi, São Paulo, 06696-000
Natalia Silva Di Gianni, +55 11 4144-9500, natalia.gianni@eurofarma.com
Taís Mendonça dos Santos, tais.santos@eurofarma.com
- Recruiting
Liga Norte Riograndense Contra o Câncer
Natal, Rio Grande do Norte, 59062-000
+55 84 98106-4634
- Recruiting
Hospital de Clínicas de Passo Fundo
Passo Fundo, Rio Grande do Sul, 99010260
+55 54 99985-7152
- Recruiting
Centro de Pesquisa Clínica Mãe de Deus/AESC
Porto Alegre, Rio Grande do Sul, 90880-481
+55 51 99835-7151
- Recruiting
Genthe Pesquisa Clínica
Rio de Janeiro, Rio de Janeiro, 20070-003
+55 21 96724-4165
- Recruiting
Artha Pesquisas Clínicas
Rio de Janeiro, Rio de Janeiro, 20070-900
+55 21 97885-3190
- Recruiting
Clinica Ibis Salvador
Salvador, Estado de Bahia, 41.820-020
+55 71 99628-2914
- Recruiting
CIPES
São José dos Campos, São Paulo, 12230-001
+55 12 99726-2171
- Recruiting
Synvia
São Paulo, São Paulo, 01139-000
+55 11 99933-6183
- Recruiting
Kosmoscience
Valinhos, São Paulo, 13270-180
+55 19 4062-8689
- Recruiting
Azidus
Valinhos, São Paulo, 13271-130
+55 19 99795-4961
About this study
Official title: Phase III Superiority, Randomized, Double-blind, Placebo-controlled, Adaptive, Multicenter Study to Compare the Efficacy and Safety of a New Concentration of an Antiandrogenic Progestogen Combined With a Reduced-dose Estrogen for the Treatment of Moderate Acne Vulgaris
This Phase III randomized, double-blind, placebo-controlled, adaptive, multicenter study evaluates the efficacy and safety of a new concentration of the fixed-dose combination EF190 in women with moderate acne vulgaris over six 28-day treatment cycles. Eligible participants will be randomized (2:1) to receive either the experimental drug or placebo alongside standard skincare. The study includes five in-person visits (screening, randomization, and three follow-ups) and three phone contacts (cycles 2, 4, and 5) to monitor adherence, adverse events, and contraceptive use. A subgroup will undergo additional exploratory assessments, including acne questionnaires, ovarian activity tests, photographic documentation, and specialized lab/ultrasound exams.
Read the detailed description
This is a Phase III, randomized, double-blind, placebo-controlled, adaptive, multicenter superiority study to evaluate the efficacy and safety of a new concentration of the fixed-dose combination EF190 in women with moderate acne vulgaris after six treatment cycles. Eligible participants will be randomized into a controlled, double-blind treatment period, receiving either the experimental drug or placebo, along with standard skin care, for six 28-day cycles.
Throughout the study, each participant must attend at least five (05) in-person clinic visits at the research center. At the screening visit (VS/V1), the participant will sign the Informed Consent Form (ICF) and the Assent Form (AF), undergo eligibility assessment, and have blood drawn. At the randomization visit (VR/V2), eligibility will be confirmed, baseline acne data (lesions and score) will be recorded, randomization (2:1 for treatment/placebo) will occur, and the study medication will be dispensed. The first dose (Day 1) will be administered on the 28th day post-menstruation. Subsequent visits (V3-V5/VF) will take place on day 15 (±3) of each cycle. The final visit (V5/VF) will assess the study's primary endpoint.
In addition to in-person visits, participants will have three (3) phone contacts, scheduled between clinic visits during cycles 2, 4, and 5. These calls aim to reinforce treatment adherence, collect information on adverse events and concomitant medications, assess discontinuation criteria, and remind participants about the use of study-permitted contraceptive methods.
Furthermore, a subgroup of participants will be selected for exploratory evaluations. These participants will complete acne control questionnaires, undergo ovarian activity assessments, have photographic documentation for acne evaluation, and receive specified laboratory and ultrasound tests as per the protocol and ICF/AF.
- Conditions
- Acne Vulgaris, Acne Vulgaris on the Face
- Being tested
- Experimental drug (Cyproterone Acetate 2 mg and Ethinyl Estradiol 0.02 mg), Placebo
- Keywords
- Acne treatment, fixed-dose combination, moderate acne, randomized controlled trial, women's dermatology, adaptive clinical study, efficacy & safety evaluation, hormonal acne research, Moderate acne vulgaris, Phase III, Randomized, Double-blind, Placebo-controlled, Adaptive design, Multicenter, Superiority trial
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental drug (Cyproterone Acetate 2 mg and Ethinyl Estradiol 0.02 mg)Drug
Cyproterone acetate 2 mg and ethinyl estradiol 0.02 mg film-coated tablets administered in a 24+4 regimen. Each treatment pack contains one 28-tablet calendar blister composed of 24 active tablets and 4 inactive tablets. Participants will receive treatment for 6 consecutive 28-day cycles during the double-blind treatment period.
PlaceboDrug
Placebo film-coated tablets administered in a 24+4 regimen. Each treatment pack contains one 28-tablet calendar blister composed of 24 placebo tablets and 4 inactive placebo tablets. Participants will receive treatment for 6 consecutive 28-day cycles during the double-blind treatment period.
| Study group | Role | What they receive |
|---|---|---|
| N0999 | Experimental | Not described Receives: Drug: Experimental drug (Cyproterone Acetate 2 mg and Ethinyl Estradiol 0.02 mg) |
| Placebo Group | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absolute reduction from baseline in the number of inflammatory acne lesions assessed at Cycle 6.
Inflammatory lesion refears to open and closed comedones, papules, pustules, and nodules
Measured: 24 weeks
Absolute reduction from baseline in the total number of acne lesions assessed at Cycle 6.
Acne lesions refears to open comedones, closed comedones, papules, pustules, and nodules.
Measured: 24 weeks
Change from Baseline of participants with scores 0 or 1 in the Static Investigator Global Assessment (ISGA) at cycle 6.
0 corresponds to "normal, clear skin with no evidence of acne vulgaris.";
1 corresponds to "skin is almost clear: few non-inflammatory lesions present, with rare non-inflamed papules (papules must be resolving and may be hyperpigmented, though not pink-red). No nodular lesions are present."; 5 indicates "numerous highly inflammatory lesions predominate, with a variable number of comedones, many papules and pustules, or nodular lesions."
Measured: 24 weeks
Secondary outcomes (3)
Change from Baseline in the inflammatory lesion count at cycle 3.
Inflammatory lesion refears to open and closed comedones, papules, pustules, and nodules
Measured: 14 weeks
Change from Baseline in the percentage of participants with scores 0 or 1 in the Static Investigator Global Assessment (ISGA) at cycle 3.
0 corresponds to "normal, clear skin with no evidence of acne vulgaris.";
1 corresponds to "skin is almost clear: few non-inflammatory lesions present, with rare non-inflamed papules (papules must be resolving and may be hyperpigmented, though not pink-red). No nodular lesions are present."; 5 indicates "numerous highly inflammatory lesions predominate, with a variable number of comedones, many papules and pustules, or nodular lesions."
Measured: 14 weeks
Absolute change from Baseline in the Acne-Specific Quality of Life Questionnaire (Acne-QoL) at cycle 3 and cycle 6.
The questionnaire has four (4) domains: Self perception (score range, 0 - 30), Role-Social (0 - 24), Role-emotional (0 - 30), and Acne Symptons (0 - 30). Overall, tem sum for all domains scores range from 0 to 114.
Each domain scores responses are numbered starting with '0' in ascending order (ie. extremely=0, very much=1, quite a bit=2, a good bit=3, somewhat=4, a little bit=5, not at all=6). Higher scores for each domain in Acne-Specific Quality of Life Questionnaire (Acne-QoL) reflect increased health related quality of life, ie. less negative self perception, social, emotional and symptomatic effects associated with acne.
Measured: 14 and 28 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2025
- Study start24 Aug 2026
- Primary completionFeb 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acne VulgarisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 531 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eurofarma Laboratorios S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06905210
- Sponsor's protocol ID
- EF190
- Acronym
- PANDORA
- Status last verified
- Oct 2026
- First submitted
- 25 Mar 2025
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III Superiority, Randomized, Double-blind, Placebo-controlled, Adaptive, Multicenter Study to Compare the Efficacy and Safety of a New Concentration of an Antiandrogenic Progestogen Combined With a Reduced-dose Estrogen for the Treatment of Moderate Acne Vulgaris
- ClinicalTrials.gov ID
- NCT06905210
- Acronym / sponsor ID
- PANDORA / EF190
- Conditions
- Acne Vulgaris, Acne Vulgaris on the Face
- Keywords
- Acne treatment, fixed-dose combination, moderate acne, randomized controlled trial, women's dermatology, adaptive clinical study, efficacy & safety evaluation, hormonal acne research
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 531 participants (estimated)
- Lead sponsor
- Eurofarma Laboratorios S.A.Industry (pharma, biotech, devices)
- Study start
- 24 Aug 2026 (actual)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 1 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This Phase III randomized, double-blind, placebo-controlled, adaptive, multicenter study evaluates the efficacy and safety of a new concentration of the fixed-dose combination EF190 in women with moderate acne vulgaris over six 28-day treatment cycles. Eligible participants will be randomized (2:1) to receive either the experimental drug or placebo alongside standard skincare. The study includes five in-person visits (screening, randomization, and three follow-ups) and three phone contacts (cycles 2, 4, and 5) to monitor adherence, adverse events, and contraceptive use. A subgroup will undergo additional exploratory assessments, including acne questionnaires, ovarian activity tests, photographic documentation, and specialized lab/ultrasound exams.
Detailed description
This is a Phase III, randomized, double-blind, placebo-controlled, adaptive, multicenter superiority study to evaluate the efficacy and safety of a new concentration of the fixed-dose combination EF190 in women with moderate acne vulgaris after six treatment cycles. Eligible participants will be randomized into a controlled, double-blind treatment period, receiving either the experimental drug or placebo, along with standard skin care, for six 28-day cycles.
Throughout the study, each participant must attend at least five (05) in-person clinic visits at the research center. At the screening visit (VS/V1), the participant will sign the Informed Consent Form (ICF) and the Assent Form (AF), undergo eligibility assessment, and have blood drawn. At the randomization visit (VR/V2), eligibility will be confirmed, baseline acne data (lesions and score) will be recorded, randomization (2:1 for treatment/placebo) will occur, and the study medication will be dispensed. The first dose (Day 1) will be administered on the 28th day post-menstruation. Subsequent visits (V3-V5/VF) will take place on day 15 (±3) of each cycle. The final visit (V5/VF) will assess the study's primary endpoint.
In addition to in-person visits, participants will have three (3) phone contacts, scheduled between clinic visits during cycles 2, 4, and 5. These calls aim to reinforce treatment adherence, collect information on adverse events and concomitant medications, assess discontinuation criteria, and remind participants about the use of study-permitted contraceptive methods.
Furthermore, a subgroup of participants will be selected for exploratory evaluations. These participants will complete acne control questionnaires, undergo ovarian activity assessments, have photographic documentation for acne evaluation, and receive specified laboratory and ultrasound tests as per the protocol and ICF/AF.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| N0999 | Experimental | Drug: Experimental drug (Cyproterone Acetate 2 mg and Ethinyl Estradiol 0.02 mg) |
| Placebo Group | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 14 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (13 listed)
- Ability to confirm voluntary participation and agree to all trial procedures by signing the Informed Consent Form (ICF) and Informed Assent Form (ITA), if applicable, prior to any procedure provided for in the protocol. Note: The adult participant or the participant's guardian when the participant is a legal minor (adolescent) must sign the ICF after understanding and agreeing to all trial procedures. The adolescent participant must provide assent by signing the ITA based on local regulations and/or guidelines prior to the start of any study procedures.
- Female sex.
- Age between 14 and 45 years (inclusive).
- At least one year after menarche.
- At least one menstrual period during the last 03 months.
Key exclusion criteria (21 listed)
- 1. Confirmed or suspected pregnancy. 2. History of childbirth, abortion or lactation in the last 3 months. 3. Participants who do not agree to use non-hormonal contraceptive methods permitted during the study, unless they are surgically sterile or who expressly declare themselves to be free from risk of pregnancy because they do not engage in sexual practices or engage in them in a non-reproductive manner.
- 4. Current or previous treatment with agents described below with a washout period shorter than that provided for each:
- At least 6 months for systemic isotretinoin and/or injectable contraceptive (such as Depo Provera);
- At least 3 months for implantable contraceptives (such as Implanon) or Levonorgestrel-Releasing Intrauterine System (such as Mirena and Kyleena);
- At least 2 months for oral contraceptives or other systemic anti-acne agents not mentioned (such as systemic antibiotics);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Experimental drug (Cyproterone Acetate 2 mg and Ethinyl Estradiol 0.02 mg)Cyproterone acetate 2 mg and ethinyl estradiol 0.02 mg film-coated tablets administered in a 24+4 regimen. Each treatment pack contains one 28-tablet calendar blister composed of 24 active tablets and 4 inactive tablets. Participants will receive treatment for 6 consecutive 28-day cycles during the double-blind treatment period. | Drug | N0999 |
| PlaceboPlacebo film-coated tablets administered in a 24+4 regimen. Each treatment pack contains one 28-tablet calendar blister composed of 24 placebo tablets and 4 inactive placebo tablets. Participants will receive treatment for 6 consecutive 28-day cycles during the double-blind treatment period. | Drug | Placebo Group |
Primary outcome
Absolute reduction from baseline in the number of inflammatory acne lesions assessed at Cycle 6.
Time frame: 24 weeks
Inflammatory lesion refears to open and closed comedones, papules, pustules, and nodules
Absolute reduction from baseline in the total number of acne lesions assessed at Cycle 6.
Time frame: 24 weeks
Acne lesions refears to open comedones, closed comedones, papules, pustules, and nodules.
Change from Baseline of participants with scores 0 or 1 in the Static Investigator Global Assessment (ISGA) at cycle 6.
Time frame: 24 weeks
0 corresponds to "normal, clear skin with no evidence of acne vulgaris."; 1 corresponds to "skin is almost clear: few non-inflammatory lesions present, with rare non-inflamed papules (papules must be resolving and may be hyperpigmented, though not pink-red). No nodular lesions are present."; 5 indicates "numerous highly inflammatory lesions predominate, with a variable number of comedones, many papules and pustules, or nodular lesions."
3 secondary outcomes
Change from Baseline in the inflammatory lesion count at cycle 3.
Time frame: 14 weeks
Change from Baseline in the percentage of participants with scores 0 or 1 in the Static Investigator Global Assessment (ISGA) at cycle 3.
Time frame: 14 weeks
Absolute change from Baseline in the Acne-Specific Quality of Life Questionnaire (Acne-QoL) at cycle 3 and cycle 6.
Time frame: 14 and 28 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
Related trials for Acne Vulgaris
Not yet recruitingPhase 3
Evaluation of the Efficacy and Safety of Fractional CO₂ Laser With and Without Intradermal Botulinum Toxin A in the Treatment of Inflammatory Facial Acne Vulgaris.
Acne, Acne Papulopustulosa
RecruitingPhase 4
Safety, Tolerability, and Clinical Effectiveness of Adapalene/Clindamycin Phosphate Gel (Klenzit®-C) in Vietnamese Patients With Mild to Moderate Acne Vulgaris
Acne
RecruitingPhase 3
Phase 3 Study of Denifanstat in Participants With Moderate to Severe Acne (AURORA)
Acne Vulgaris
RecruitingPhase 4
Comparing Nadifloxacin Plus Tretinoin Versus Clindamycin Plus Tretinoin Creams for Mild-to-Moderate Acne
Acne Vulgaris
Active, not recruiting
Clinical Study to Evaluate the Safety and Efficacy of Candela Technology
Hair Reduction, Tattoo Removal
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Taís Mendonça dos Santos contact
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Experimental drug (Cyproterone Acetate 2 mg and Ethinyl Estradiol 0.02 mg) in people with Acne Vulgaris and Acne Vulgaris on the Face, run by Eurofarma Laboratorios S.A. at 18 sites in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Natalia Silva Di Gianni (+55 11 5090 8411, natalia.gianni@eurofarma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Absolute reduction from baseline in the number of inflammatory acne lesions assessed at Cycle 6. (time frame: 24 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.