CTRI/2022/11/047525招募中不适用
A Multi-Center, Double-Blind, Randomized, Three-Arm, Placebo Controlled, Parallel- Group Study, Comparing Tretinoin Cream, 0.025% (Aleor Dermaceuticals Limited, India.) to Retin-A® (Tretinoin)Cream, 0.025% (Bausch Health US, LLC., USA) And Both Active Treatments to A Placebo Control in The Treatment of Acne Vulgaris
Aleor Dermaceuticals Limited India (Alembic Pharmaceuticals Limited)16 个研究点 分布在 1 个国家目标入组 1,100 人开始时间: 2022年11月30日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,100
- 试验地点
- 16
- 主要终点
- The primary efficacy endpoints are the mean
研究概览
简要总结
It is Multi-center, double-blind, randiomized, three-arm, placebo controlled, parallel-group study, comparing tretinoin cream 0.025% (Aleor dermaceuticals Limited, India) to Retin-A (Tretinoin) cream, 0.025% (Bausch Health US, LLC., USA) and both active treatments to a placebo control in the treatment of Active Vulgaris. Approximately 1100 subjects will be assigned in a 2:2:1 ratio to treatment with the test product, Reference product and Placebo. The duration of each subject’s participation in the study will be 84 days. Scheduled study visits will include; Visit 1 (Baseline Day 0), Visit 2 (First Interim Visit, Day 28), Visit 3 (Second Interim Visit, Day 56), Visit 4 (Day 84). A window period of ±4 days will be considered acceptable for each scheduled visit following the baseline visit. The treatment area of enrolled subjects will be assessed using IGA and lesion counts.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 12.00 Year(s) 至 40.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Male or non-pregnant, nonlactating female aged between 12 and 40 years with a clinical diagnosis of acne vulgaris.
- •2.Subjects who are 18 years of age or older (up to the age of 40) must have provided IRB/IEC approved written informed consent.
- •Subjects 12 to 17 years of age, inclusive, must have provided IRB/IEC approved written assent; this written assent must be accompanied by an IRB/IEC approved written informed consent from the Subject’s legally acceptable representative (parent or guardian).
- •In addition, all Subjects or their legally acceptable representatives (parent or guardian) must sign a HIPAA authorization.
- •3.Subjects must have less than or equal to 25 non-inflammatory lesions (open and closed comedones) AND less than or equal to 20 inflammatory lesions (papules and pustules) AND greater than or equal to 2 nodulocystic lesions (i.e., nodules and cysts), at baseline on the face.
- •For the purposes of study treatment and evaluation, these lesions should be limited to the facial treatment area.
- •All lesions will be counted, including those present on the nose.
- •Subjects may have acne lesions on other areas of the body which will also be excluded from the count, treatment, and the Investigator’s Global Assessment (IGA) evaluation (e.g., on the back, chest and arms).
- •4.Subjects must have a definite clinical diagnosis of acne vulgaris severity grade 2, 3, or 4 as per the Investigator’s Global Assessment (IGA).
- •5.Subjects must be willing to refrain from using all other topical acne medications or antibiotics during the 12-week treatment period, other than the investigational product.
- •Female Subjects of child bearing potential (excluding women who are premenarchal, surgically sterilized (by hysterectomy or bilateral oophorectomy) or postmenopausal for at least 1 year), in addition to having a negative urine pregnancy test, must be willing to use an acceptable form of birth control during the study from the day of the first dose administration to 30 days after the last administration of study drug.
- •All male Subjects must agree to use accepted methods of birth control with their partners, from the day of the first dose administration to 30 days after the last administration of study drug.
- •Abstinence is an acceptable method of birth control.
- •Female partners should use an acceptable method of birth control.
- •Subjects must be willing and able to understand and comply with the requirements of the protocol, including attendance at the required study visits.
- •9.Subjects must be in good health and free from any clinically significant disease, including but not limited to, conditions that may interfere with the evaluation of acne vulgaris.
- •Such conditions include, but are not limited to the following: auto immune disease; rosacea; seborrheic dermatitis; perioral dermatitis; corticosteroid-induced acne; carcinoid syndrome; mastocytosis; acneiform eruptions caused by make-up and medication, facial psoriasis and facial eczema.
- •10.Subjects who use make-up must have used the same brands/types of make-up for a minimum period of 14 days prior to study entry and must agree to not change make-up brand/type or frequency of use throughout the study.
排除标准
- •Female Subjects who are pregnant, nursing or planning to become pregnant during study participation.
- •Subjects with a history of hypersensitivity or allergy to tretinoin, retinoids, or any of the study medication ingredients.
- •Subjects with the presence of any skin condition that would interfere with the diagnosis or assessment of acne vulgaris (on the face, rosacea, dermatitis, psoriasis, squamous cell carcinoma, eczema, acneiform eruptions caused by medications, steroid acne, steroid folliculitis, or bacterial folliculitis).
- •Subjects with excessive facial hair (beards, sideburns, moustaches) that would interfere with diagnosis or assessment of acne vulgaris.
- •Subjects with a baseline irritation score of 3 that is equal to severe (marked, intense), erythema, dryness, burning or stinging, erosion, edema, pain and itching.
- •Subjects who have used within 6 months prior to baseline or use during the study of oral retinoids (Accutane) ortherapeutic vitamin A supplements of greater than ten thousand units per day (multivitamins are allowed).
- •Subjects who have had laser therapy, electrodessication and phototherapy (Clear Light) to the facial area within 6 months prior to study entry.
- •Subjects who have received radiation therapy and (or antineoplastic agents) within 3 months prior to baseline.
- •Subjects who have used for less than 3 months prior to baseline of estrogens or oral contraceptives, use of such therapy must remain constant throughout the study.
- •Subjects who have used any of the following procedures on the face within 1 month prior to baseline or use during the study; cryodestruction or chemodestruction, dermabrasion, photodynamic therapy, acne surgery, Intralesional steroids, or X-ray therapy.
- •Subjects who have used any of the following treatments within 2 weeks prior to baseline or during the study, topical steroids, topical retinoids, topical acne treatments, including over the counter preparations, topical anti inflammatory agents, or topical antibiotics.
- •Subjects who have used any of the following treatments within 2 weeks prior to baseline or during the study, abradants, peels containing glycolic or other acids, washes or soaps, containing glycolic acid, alpha hydroxy acids, sulfacetamide sodium, non mild facial cleansers, moisturizers that contained retinol.
- •Subjects who have performed wax depilation of the face within 14 days prior to baseline.
- •Subjects who have had cosmetic procedures (facials) which may affect the efficacy and safety profile of the investigational product within 14 days prior to study entry.
- •Subjects who have ongoing malignancies requiring systemic treatment or who have any malignancy of the skin of the facial area.
- •Subjects with eczematous skin.
- •Subjects who currently have or have recently had bacterial folliculitis on the face.
- •Subjects who have unstable medical disorders that are clinically significant or have life threatening diseases, or other medical condition that, in the Investigator opinion, would place the study Subject at undue risk by participation or could jeopardize the integrity of the study evaluations.
- •Subjects who engage in activities that involve excessive or prolonged exposure to sunlight or weather extremes, such as wind or cold.
- •Subjects who consume excessive amounts of alcohol (greater than two drinks per day) or use drugs of abuse (including, but not limited to, cannabinoids, cocaine and barbiturates).
- •Subjects who have participated in an investigational drug study (that is Subjects have been treated with an investigational drug) within 30 days prior to baseline.
- •Subjects who are participating in non treatment studies such as observational studies or registry studies can be considered for inclusion.
- •Subjects who have been previously enrolled in this study.
- •Subjects who live in the same household with subjects who are participating or have been previously enrolled in this study.
- •Subjects who use a sauna within 48 hours prior to baseline.
- •Subject having symptoms of Coronavirus Disease 2019 (COVID 19) within the 14 days prior to baseline (Visit 1) or have had close contact with someone with suspected or confirmed Severe Acute Respiratory Syndrome Coronavirus 2 (SARS CoV 2) infection within 14 days prior to baseline (visit1) or who are at high risk of SARS CoV 2 infection, defined as adults whose locations or circumstances put them at appreciable risk of exposure to SARS CoV
- •Stuffy or runny nose, sore throat, shortness of breath (difficulty breathing), cough, low energy or tiredness, muscle or body aches, headache, chills or shivering, feeling hot or feverish, vomiting, diarrhoea, loss of sense of taste and smell.
- •Participants who, in the judgment of the investigator, are at higher risk for acquiring COVID 19 (example use of mass transportation, relevant demographics).
- •Individuals currently working in occupations with high risk of exposure to SARS CoV 2 (example healthcare worker, emergency response personnel).
结局指标
主要结局
The primary efficacy endpoints are the mean
时间窗: Baseline to 12-Week treatment period
percent change from baseline to week 12 in the inflammatory (papules and pustules) and in the non-inflammatory (open and
时间窗: Baseline to 12-Week treatment period
closed comedones) lesion counts
时间窗: Baseline to 12-Week treatment period
次要结局
- Superiority of the Test treatment versus the Vehicle and for the Reference treatment versus the Vehicle.(Baseline to 12-Week treatment period)
研究者
研究点 (16)
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