Esta página se tradujo automáticamente y no se garantiza la precisión de la traducción. por favor refiérase a versión inglesa para un texto fuente.

Estudio de fase III, aleatorizado, doble ciego, controlado con placebo, multicéntrico de nuevo progestógeno antiandrogénico + estrógeno bajo en dosis bajas para vulgaris de acné moderado (PANDORA)

23 de octubre de 2026 actualizado por: Eurofarma Laboratorios S.A.

Estudio de superioridad de fase III, aleatorizado, doble ciego, controlado con placebo, adaptativo y multicéntrico para comparar la eficacia y seguridad de una nueva concentración de un progestógeno antiandrogénico combinado con una dosis reducida de estrógeno para el tratamiento de la acné vulgar moderada

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.

Descripción general del estudio

Estado

Reclutamiento

Condiciones

Intervención / Tratamiento

Descripción detallada

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.

Tipo de estudio

Intervencionista

Inscripción (Estimado)

531

Fase

  • Fase 3

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Copia de seguridad de contactos de estudio

Ubicaciones de estudio

  • Brasil
    • Estado de Bahia
      • Salvador, Estado de Bahia, Brasil, 41.820-020
        • Reclutamiento
        • Clinica Ibis Salvador
        • Contacto:
          • Número de teléfono: +55 71 99628-2914
    • Federal District
      • Brasília, Federal District, Brasil, 70335-902
        • Reclutamiento
        • Instituto de Gestão Estratégica de Saúde do Distrito Federal-IGESDF
        • Contacto:
          • Número de teléfono: +55 61 98311-2895
    • Goiás
      • Goiânia, Goiás, Brasil, 74.935-530
        • Reclutamiento
        • ICF Ciências Farmacêutica - Unidade Clínica
        • Contacto:
          • Número de teléfono: +55 62 99963-6770
      • Goiânia, Goiás, Brasil, 74453-200
        • Reclutamiento
        • Centro de Pesquisa Clínica - Hospital Ruy Azeredo
        • Contacto:
          • Número de teléfono: +55 11 98764-3924
    • Pará
      • Belém, Pará, Brasil, 66093-681
        • Reclutamiento
        • Norte Pesquisa Clínica
        • Contacto:
          • Número de teléfono: +55 91 98251-0454
    • Rio Grande do Norte
      • Natal, Rio Grande do Norte, Brasil, 59062-000
        • Reclutamiento
        • Liga Norte Riograndense Contra o Câncer
        • Contacto:
          • Número de teléfono: +55 84 98106-4634
    • Rio Grande do Sul
      • Passo Fundo, Rio Grande do Sul, Brasil, 99010260
        • Reclutamiento
        • Hospital de Clínicas de Passo Fundo
        • Contacto:
          • Número de teléfono: +55 54 99985-7152
      • Porto Alegre, Rio Grande do Sul, Brasil, 90880-481
        • Reclutamiento
        • Centro de Pesquisa Clínica Mãe de Deus/AESC
        • Contacto:
          • Número de teléfono: +55 51 99835-7151
    • Rio de Janeiro
      • Rio de Janeiro, Rio de Janeiro, Brasil, 20070-003
        • Reclutamiento
        • Genthe Pesquisa Clínica
        • Contacto:
          • Número de teléfono: +55 21 96724-4165
      • Rio de Janeiro, Rio de Janeiro, Brasil, 20070-900
        • Reclutamiento
        • Artha Pesquisas Clínicas
        • Contacto:
          • Número de teléfono: +55 21 97885-3190
    • São Paulo
      • Bragança Paulista, São Paulo, Brasil, 12.916-542
        • Reclutamiento
        • Hospital Universitário São Francisco na Providência de Deus - HUSF
        • Contacto:
          • Número de teléfono: +55 11 2490-1130
      • Campinas, São Paulo, Brasil, 12916-900
        • Reclutamiento
        • CLINICA GERAL INVESTIGA LTDA (Allergisa)
        • Contacto:
          • Número de teléfono: +55 19 99778-0204
      • Campinas, São Paulo, Brasil, 13086-045
        • Reclutamiento
        • Synvia
        • Contacto:
          • Número de teléfono: +55 19 99933-1385
      • Itapevi, São Paulo, Brasil, 06696-000
      • São José dos Campos, São Paulo, Brasil, 12230-001
        • Reclutamiento
        • CIPES
        • Contacto:
          • Número de teléfono: +55 12 99726-2171
      • São Paulo, São Paulo, Brasil, 01139-000
        • Reclutamiento
        • Synvia
        • Contacto:
          • Número de teléfono: +55 11 99933-6183
      • Valinhos, São Paulo, Brasil, 13270-180
        • Reclutamiento
        • Kosmoscience
        • Contacto:
          • Número de teléfono: +55 19 4062-8689
      • Valinhos, São Paulo, Brasil, 13271-130
        • Reclutamiento
        • Azidus
        • Contacto:
          • Número de teléfono: +55 19 99795-4961

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

14 años a 45 años (Niño, Adulto)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Femenino

Descripción

Inclusion Criteria:

  1. 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.
  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.

    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.

Exclusion Criteria:

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:

  1. At least 6 months for systemic isotretinoin and/or injectable contraceptive (such as Depo Provera);

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

  3. At least 2 months for oral contraceptives or other systemic anti-acne agents not mentioned (such as systemic antibiotics);

  4. At least 4 weeks for topical retinoids;

  5. 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

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Cuadruplicar

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Comparador de placebos: Grupo placebo
Droga: Placebo

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.
Experimental: N0999
Droga: 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.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Absolute reduction from baseline in the number of inflammatory acne lesions assessed at Cycle 6.
Periodo de tiempo: 24 weeks

Inflammatory lesion refears to open and closed comedones, papules, pustules, and nodules
24 weeks
Absolute reduction from baseline in the total number of acne lesions assessed at Cycle 6.
Periodo de tiempo: 24 weeks

Acne lesions refears to open comedones, closed comedones, papules, pustules, and nodules.
24 weeks
Change from Baseline of participants with scores 0 or 1 in the Static Investigator Global Assessment (ISGA) at cycle 6.
Periodo de tiempo: 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."
24 weeks

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change from Baseline in the inflammatory lesion count at cycle 3.
Periodo de tiempo: 14 weeks

Inflammatory lesion refears to open and closed comedones, papules, pustules, and nodules
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.
Periodo de tiempo: 14 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."
14 weeks
Absolute change from Baseline in the Acne-Specific Quality of Life Questionnaire (Acne-QoL) at cycle 3 and cycle 6.
Periodo de tiempo: 14 and 28 weeks

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.
14 and 28 weeks

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Eurofarma Laboratorios S.A.

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

24 de agosto de 2026

Finalización primaria (Estimado)

1 de febrero de 2027

Finalización del estudio (Estimado)

1 de marzo de 2027

Fechas de registro del estudio

Enviado por primera vez

25 de marzo de 2025

Primero enviado que cumplió con los criterios de control de calidad

31 de marzo de 2025

Publicado por primera vez (Actual)

1 de abril de 2025

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

27 de octubre de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

23 de octubre de 2026

Última verificación

1 de octubre de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • EF190

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

Suscribir