III 상, 무작위, 이중 맹검, 위약 대조, 중간 여드름 vulgaris에 대한 새로운 항 조상 프로 게스트 겐 + 저용량 에스트로겐에 대한 다기관 연구 (PANDORA)
III 상 III, 무작위, 이중 맹검, 위약 대조, 적응 형, 다기관 연구를위한 적당한 여드름 vulgaris의 치료를 위해 감소 된 용량 에스트로겐과 결합 된 새로운 농도의 항해성 프로게스 토지의 효능 및 안전성을 비교하기위한 우월성.
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.
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
상세 설명
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.
연구 유형
연구 유형
등록 (추정된)
등록
단계
단계
- 3단계
연락처 및 위치
연구 연락처
연구 연락처
- 이름: Natalia Silva Di Gianni
- 전화번호: +55 11 5090 8411
- 이메일: natalia.gianni@eurofarma.com
연구 연락처 백업
- 이름: Taís Mendonça dos Santos
- 이메일: tais.santos@eurofarma.com
연구 장소
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Estado de Bahia
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Salvador, Estado de Bahia, 브라질, 41.820-020
- 모병
- Clinica Ibis Salvador
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연락하다:
- 전화번호: +55 71 99628-2914
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Federal District
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Brasília, Federal District, 브라질, 70335-902
- 모병
- Instituto de Gestão Estratégica de Saúde do Distrito Federal-IGESDF
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연락하다:
- 전화번호: +55 61 98311-2895
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Goiás
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Goiânia, Goiás, 브라질, 74.935-530
- 모병
- ICF Ciências Farmacêutica - Unidade Clínica
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연락하다:
- 전화번호: +55 62 99963-6770
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Goiânia, Goiás, 브라질, 74453-200
- 모병
- Centro de Pesquisa Clínica - Hospital Ruy Azeredo
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연락하다:
- 전화번호: +55 11 98764-3924
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Pará
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Belém, Pará, 브라질, 66093-681
- 모병
- Norte Pesquisa Clínica
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연락하다:
- 전화번호: +55 91 98251-0454
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Rio Grande do Norte
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Natal, Rio Grande do Norte, 브라질, 59062-000
- 모병
- Liga Norte Riograndense Contra o Câncer
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연락하다:
- 전화번호: +55 84 98106-4634
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Rio Grande do Sul
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Passo Fundo, Rio Grande do Sul, 브라질, 99010260
- 모병
- Hospital de Clínicas de Passo Fundo
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연락하다:
- 전화번호: +55 54 99985-7152
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Porto Alegre, Rio Grande do Sul, 브라질, 90880-481
- 모병
- Centro de Pesquisa Clínica Mãe de Deus/AESC
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연락하다:
- 전화번호: +55 51 99835-7151
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Rio de Janeiro
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Rio de Janeiro, Rio de Janeiro, 브라질, 20070-003
- 모병
- Genthe Pesquisa Clínica
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연락하다:
- 전화번호: +55 21 96724-4165
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Rio de Janeiro, Rio de Janeiro, 브라질, 20070-900
- 모병
- Artha Pesquisas Clínicas
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연락하다:
- 전화번호: +55 21 97885-3190
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São Paulo
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Bragança Paulista, São Paulo, 브라질, 12.916-542
- 모병
- Hospital Universitário São Francisco na Providência de Deus - HUSF
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연락하다:
- 전화번호: +55 11 2490-1130
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Campinas, São Paulo, 브라질, 12916-900
- 모병
- CLINICA GERAL INVESTIGA LTDA (Allergisa)
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연락하다:
- 전화번호: +55 19 99778-0204
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Campinas, São Paulo, 브라질, 13086-045
- 모병
- Synvia
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연락하다:
- 전화번호: +55 19 99933-1385
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Itapevi, São Paulo, 브라질, 06696-000
- 모병
- Eurofarma Laboratórios S.A
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연락하다:
- Taís Mendonça dos Santos
- 이메일: tais.santos@eurofarma.com
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연락하다:
- Natalia Silva Di Gianni
- 전화번호: +55 11 4144-9500
- 이메일: natalia.gianni@eurofarma.com
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São José dos Campos, São Paulo, 브라질, 12230-001
- 모병
- CIPES
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연락하다:
- 전화번호: +55 12 99726-2171
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São Paulo, São Paulo, 브라질, 01139-000
- 모병
- Synvia
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연락하다:
- 전화번호: +55 11 99933-6183
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Valinhos, São Paulo, 브라질, 13270-180
- 모병
- Kosmoscience
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연락하다:
- 전화번호: +55 19 4062-8689
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Valinhos, São Paulo, 브라질, 13271-130
- 모병
- Azidus
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연락하다:
- 전화번호: +55 19 99795-4961
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참여기준
자격 기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- 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:
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.
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At least 15 inflammatory lesions (papules or pustules);
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At least 10 non-inflammatory lesions (comedones); and
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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:
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At least 6 months for systemic isotretinoin and/or injectable contraceptive (such as Depo Provera);
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At least 3 months for implantable contraceptives (such as Implanon) or Levonorgestrel-Releasing Intrauterine System (such as Mirena and Kyleena);
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At least 2 months for oral contraceptives or other systemic anti-acne agents not mentioned (such as systemic antibiotics);
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At least 4 weeks for topical retinoids;
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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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 네 배로
팔의 수
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
|
위약 비교기: 플라시보 그룹
|
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. |
|
실험적: N0999
|
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. |
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Absolute reduction from baseline in the number of inflammatory acne lesions assessed at Cycle 6.
기간: 24 weeks
|
Inflammatory lesion refears to open and closed comedones, papules, pustules, and nodules |
24 weeks
|
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Absolute reduction from baseline in the total number of acne lesions assessed at Cycle 6.
기간: 24 weeks
|
Acne lesions refears to open comedones, closed comedones, papules, pustules, and nodules. |
24 weeks
|
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Change from Baseline of participants with scores 0 or 1 in the Static Investigator Global Assessment (ISGA) at cycle 6.
기간: 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
|
2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Change from Baseline in the inflammatory lesion count at cycle 3.
기간: 14 weeks
|
Inflammatory lesion refears to open and closed comedones, papules, pustules, and nodules |
14 weeks
|
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Change from Baseline in the percentage of participants with scores 0 or 1 in the Static Investigator Global Assessment (ISGA) at cycle 3.
기간: 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.
기간: 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
|
공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
연구 시작
기본 완료 (추정된)
기본 완료
연구 완료 (추정된)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
기타 연구 ID 번호
- EF190
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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