EUCTR2020-006050-51-FR进行中（未招募）1 期
Evaluation of the risk of atrophic acne scar formation during treatment of acne vulgaris subjects with trifarotene 50 µg/g cream versus vehicle cream over 24 weeks - Study of Trifarotene cream to Assess Risk of aTrophic acne scar formation (START)
Galderma S.A.0 个研究点目标入组 118 人开始时间: 2021年4月19日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 118
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Male or female subject aged 17 to 35 years inclusive, at Screening visit.
- •2. Subjectwith clinical diagnosis of acne vulgaris on the face as defined by (excluding the nose and middle zone of approximatey 2 cm):
- •a. Investigator’s Global Assessment (IGA) score of 3 (Moderate) or 4 (Severe), with the same score on both sides of the face; and
- •b. A minimum of 20 inflammatory lesions (papules and pustules)in total, with at least 10 on each side; and
- •c. No more than 2 nodules (?1cm in diameter) on the face; and d. A minimum of 10 atrophic acne scars in total ( >2mm),
- •3. Subject with a symmetrical number of the following lesions/scars on the whole face (i.e., there are no more than twice as many lesions/scars of each type on one half of the face than on the other half):
- •a. Inflammatory and non-inflammatory lesions; and
- •b. Atrophic acne scars (minimum of 4 scars per half-face)
- •4. The subject is a female of non-childbearing potential (premenarchal or postmenopausal [absence of menstrual bleeding for 1 year prior to Screening, without any other medical reason], hysterectomy or bilateral oophorectomy).
- •5. The subject is a female of childbearing potential:
- •5.1 Who is willing to undergo UPTs throughout the course of the study, as required.
- •5.2 Who has been strictly abstinent for 1 month prior to Screening and agrees to continue for the duration of the clinical study and at least 1month after the last study drug application, OR Who agrees to use highly effective and approved contraceptive method(s) for the duration of the study and at least 1 month after the last study drug application. Highlyeffective methods of contraception include:
- •a. bilateral tubal ligation;
- •b. approved combined oral contraceptives (estrogens and progesterone), implanted or injectable contraceptives, or hormonal contraceptive vaginal rings with a stable dose for at least 1 month prior to the Screening visit;
- •c. intrauterine device or intrauterine hormonal-releasing system inserted at least 1 month prior to the Screening visit;
- •d. vasectomized partner for at least 3 months prior to the Screening visit
- •Note: This criterion applies to a prepubertal female subject whobegins menses during the study.
- •6. If a female of childbearing potential uses oral contraceptives that are also approved for treating acne vulgaris (such as cyproterone acetate and ethinyl estradiol; drospirenone and ethinyl estradiol; norgestimate and ethinyl estradiol; norenthindrone acetate and ethinyl estradiol; etc) the dose should be stable for at least 6 months prior to the Screening visit.
- •7. Subject having read, understood and signed the approved Informed Consent Form (ICF) prior to any participation in the clinical study. Subject under the age of 18 having signed an assent form to participate in the clinical study and their parent(s) or legal representative having read and signed the informed consent form prior to any clinical study related procedure.
- •8. Subject (and legal guardian, if applicable) agrees and is able to comply with all time commitments and procedural requirements of the protocol, including daily recording of dosing compliance by the subject using an electronic tablet provided for this study, as well as taking daily videos of study medication use. Consent to taking daily videos is mandatory for study participation at all sites.
- •9. Subject agrees to having photographs taken (mandatory for study participation, at designated imaging centers), and verified by the subject sign
排除标准
- •1. Subject with acne conglobata, acne fulminans, secondary acne [chloracne, drug-induced acne, polycystic ovary syndrome (PCOS), pyogenic arthritis-pyoderma gangrenosum-acne (PAPA), synovitis-acne-pustulosis-hyperostosis-osteitis (SAPHO), seborrhoea-acnehirsutism-androgenetic alopecia (SAHA), Hidradenitis suppurativa (HS), congenital adrenal hyperplasia (CAH) etc.], nodulocystic acne, acne requiring systemic treatment.
- •2. Subject with any acne cyst on the face or with more than 3 excoriated acne lesions.
- •3. Subject with known active or chronic allergies or suspected allergy to trifarotene or excipients of the formulation.
- •4. Prior failure of trifarotene treatment including intolerancethat resulted in stopping treatment; lack of clinical improvement, etc.
- •5. Subject with facial dermal conditions (e.g. tattoo, skin abrasion, eczema, sunburned skin, scars, nevi, etc.) that may interfere with study assessments in the opinion of the investigator.
- •6. Subject with excessive facial hair that would interfere with study assessments, as judged by the investigator, or unwilling to keep facial hair well-groomed prior to study visits, as judged appropriate by the investigator to perform study assessments.
- •7. Pregnant women (positive urine pregnancy test at the Screening or Baseline visits), breastfeeding women, or women planning a pregnancy during the study or within 1 month after the last study drug application
- •8. Subject with known impaired hepatic or renal functions, based on medical history.
- •9. Subjects taking Vitamin A supplements in excess of the recommended daily allowance (4000 –5000 IU; no washout period is required)
- •10.Subjects with a washout period for topical treatmentor procedures on the face less than:
- •- Topical treatments: Corticosteroids, antibiotics, benzoyl peroxide, azelaic acid, alpha hydroxy acids, salicylic acid, zinc containing treatments, hydroquinones, and other anti-acne treatments
- •- Topical retinoids 2 weeks
- •- Clascoterone cream 1% (Winlevi) 2 weeks
- •- Cosmetic/aesthetic procedures (e.g., comedo extraction, desquamating, or abrasive agents, adhesive”pore” cleansing strips) 1 week
- •- Wax epilation 2 weeks
- •- Photodynamic therapy 4 weeks
- •- Laser therapy, microdermabrasion, deep chemical peel, and other plastic surgical treatments for acne 12 weeks
- •11.Subject with a washout period for systemic treatmentless than:
- •- Corticosteroids, (except locally acting corticosteroids such as inhaled or intrathecal), antibiotics and spironolactone 4 weeks
- •- Oral retinoids/isotretinoin 12 weeks
- •- Cyproterone acetate / Chlormadinone acetate 12 weeks
- •- Immunomodulators 12 weeks
- •12.Currently receiving any prescription testosterone therapy (e.g., testosterone cypionate, testosterone enanthate, testosterone pellet, testosterone undecanoate) or on a testosterone -booster or prescription testosterone (e.g., DHEA, Omnadren®, Sustanon®, testosterone cypionate, testosterone enanthate, testosterone propionate, testosterone phenylpropionate) or testosterone supplements (e.g., Tribulus).
- •13.The subject is unwilling to or unable to refrain from use of prohibited medication or procedures during the clinical study (seeSection 5.4.12.5)
- •14.Subject who foresees intensive ultraviolet exposure during the study
- •15.Subject who is at risk in terms of precautions, warnings, and contraindications for trifarotene based on approved labeling.
- •16.Subject with an acute / chronic disease or a history of major medical or surgical or psychiatric condi
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