CTRI/2024/08/072412尚未招募4 期
A prospective, multi center, open label phase IV clinical study to evaluate the safety and efficacy of Trifarotene or Aklief 50 microgram per gram cream in subjects with acne vulgaris over 12 weeks.
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- GALDERMA SA
- 入组人数
- 250
- 试验地点
- 20
- 主要终点
- • Number of Adverse Events and Adverse Drug Reactions (AE/ADR)
研究概览
简要总结
This is a multi-center, open label Phase IV study evaluating trifarotene cream in treating acne vulgaris on the face and trunk. Approximately 250 subjects aged 12 years or older are planned, with approximately 200 to complete the study, at approximately 15 study centers in India. Subject eligibility will be evaluated over a 14-day screening period. The objective of this trial is to assess the safety and efficacy of trifarotene (Aklief) 50 Mcg/g cream in India. Qualifying subjects will complete Baseline assessments. If they satisfy the inclusion and exclusion criteria, they will receive Trifarotene for a 12-week treatment period. The safety and efficacy assessments will be performed at Weeks 1, 4, 8, and 12 at the clinic.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 12.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Subjects of either sex aged 12 years and above who have given written informed consent or assent to participate in the study.
- •Subjects under the age of 18 having signed an assent form to participate in the clinical trial and their parent(s) or legal representative having read and signed the informed consent form prior to any clinical trial related procedure, samples and photos are collected.(Note This DCGI approved trial has no upper age limit subjects aged more than or equal to 12 years are inclusive).
- •Subjects with facial acne vulgaris severity grade of 2-3 (mild to moderate) on Investigator Global Assessment (IGA) Scale and truncal acne vulgaris of severity grade of 2-3 (mild to moderate) on the Physician Global Assessment (PGA) Scale at screening and Baseline visits.
- •Subject has a minimum of 20 inflammatory and 20 non-inflammatory lesions on the face and trunk.
- •Female subjects of childbearing potential must have a negative urine pregnancy test at Baseline Visit.
- •Female subjects of childbearing potential must agree either to commit to true abstinence throughout the study, when this is in line with the preferred and usual lifestyle of the subject, or to use an adequate and approved method of contraception throughout the study.
- •This criterion also applies to a prepubertal female subject who begins menses during the study.
- •Adequate and approved methods of contraception applicable for the subject and/or her partner are: Progestogen-only oral hormonal contraception, Combination of male condom with cap, diaphragm, or sponge with spermicide, Combined (estrogen- and progestogen-containing) oral, intravaginal, or transdermal hormonal contraception, Injectable or implanted hormonal contraception, Intrauterine devices or intrauterine hormone-releasing system and Bilateral tubal ligation at least 3 months before the study, Bilateral vasectomy of partner at least 3 months before the study.
- •Female of non-childbearing potential, hysterectomy, bilateral salpingectomy, bilateral oophorectomy.
排除标准
- •Subjects with severe forms of acne, and has more than 1 nodule on either the face or trunk and acne cyst on face or trunk at screening and Baseline Visit.
- •Subjects with beard or facial hair, tattoos on the application area which interfers with study assessment.
- •Subjects with any uncontrolled or serious disease or any medical or surgical condition, has known or suspected allergies or sensitivities to any components of any of the study drugs.
- •Females who are Pregnant, lactating women or planning pregnancy.
- •Female subject of childbearing potential using combined oral contraceptives approved as acne treatments in whom the dose has not been stable for at least 6 months prior to the Baseline visit.
- •Subject with known impaired hepatic or renal functions and with an acute / chronic disease or a history of major medical or psychiatric condition or surgical interventions.
- •Subjects with a washout period for topical treatment or procedures on the face and trunk i.e, less than 2 weeks for Topical treatments: Corticosteroids, antibiotics, benzoyl peroxide, azelaic acid, hydroxyacids, Zinc containing treatments, other anti-inflammatory drugs or other acne treatments (for example salicylic acid treatments/ transdermal contraceptives are forbidden if used to treat acne), less than 4 weeks for Topical Retinoids (including fixed drug combinations), less than 1 week for Cosmetic/aesthetic procedures on the face (e.g., comedone extraction, desquamating, or abrasive agents, adhesive cleansing strips), less than 2 weeks for Wax epliation, less than 6 weeks for Photodynamic therapy and less than 3 months for Laser therapy, microdermabrasion, deep chemical peel, plastic surgery for acne.
- •Subject with a washout period for systemic treatment i.e., less than 1 month for Corticosteroids, (except locally acting corticosteroids such as inhaled or intrathecal or dermal application at distance from the face), tetracyclines, other antibiotics (except penicillin), less than 6 months for Oral retinoids/isotretinoin, less than 6 months for Cyproterone acetate / Chlormadinone acetate, less than 3 months for Spironolactone/ Drospirenone, less than 3 months for Immunomodulators and less than 1 month for Oral contraceptives for acne.
- •Subject who has used tanning booths or lamps or had excessive ultraviolet (UV) radiation exposure within 1 month prior to clinical trial entry or foresees intensive UV exposure during the study (mountain sports, sailing, sunbathing, etc.)
- •Subject who is at risk in terms of precautions, warnings, and contraindications.
- •Subject under guardianship, hospitalized subject in a public or private institution for a reason other than the research, and subject deprived of his/her freedom.
- •Subject who has participated in another investigational drug or device research study within 30 days prior to Baseline or is in an exclusion period from a previous clinical trial.
- •Subject who is unable to communicate or cooperate with the investigator due to language problems, poor mental development, or impaired cerebral function.
结局指标
主要结局
• Number of Adverse Events and Adverse Drug Reactions (AE/ADR)
时间窗: Up to 12 weeks
• Number of Serious Adverse Events and Serious Adverse Drug Reactions (SAE/SADR)
时间窗: Up to 12 weeks
• Number of Unexpected Adverse Events and Adverse Drug Reactions (Unexpected AE/ADR)
时间窗: Up to 12 weeks
• Number of Adverse Events of Special Interest (AESIs)
时间窗: Up to 12 weeks
•Local Tolerability on the Face and Trunk Assessed for Each Individual Sign (Erythema, Scaling, Dryness, and Stinging/Burning) at Each Visit
时间窗: Up to 12 weeks
次要结局
- • Percentage of Subjects who Achieve at Least a 1-grade Improvement in IGA score for Facial Acne/ PGA Score for Truncal Acne From Baseline to Week 12(• Percentage of Subjects who Achieve 0 or 1 in IGA score for Facial acne / PGA score for Truncal Acne From Baseline to Week 12)
研究者
研究点 (20)
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