CTRI/2024/07/069994已完成不适用
A multi-center, double-blind, randomized, three-arm, active and placebo-controlled, parallel group design to evaluate the bioequivalence using clinical endpoint of Tretinoin Gel Microsphere, 0.08 percent (Amneal Pharmaceuticals LLC, USA) with Retin-A Micro (tretinoin) Gel Microsphere 0.08 percent (Valeant Pharmaceuticals North America LLC) in subjects with acne vulgaris.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,071
- 试验地点
- 21
- 主要终点
- 1 Mean percent change from baseline to week 12 in the inflammatory (papules and pustules) lesion count.
研究概览
简要总结
AMNEAL PHARMACEUTICALS LLC, USA. has developed a generic product (TRETINOIN GEL MICROSPHERE, 0.08%) of RETIN-A MICRO® (TRETINOIN) GEL MICROSPHERE 0.08%. AMNEAL PHARMACEUTICALS LLC, USA wants to conduct the study to assess the BIOEQUIVALENCE of test product in comparison to the reference product using clinical endpoint evaluation & superiority of test and Reference product over Placebo product in subjects with ACNE VULGARIS in line with the applicable USFDA’s Guidance.
A MULTI-CENTER, DOUBLE-BLIND, RANDOMIZED, THREE ARM, ACTIVE AND PLACEBO-CONTROLLED, PARALLEL GROUP DESIGN TO EVALUATE THE BIOEQUIVALENCE USING CLINICAL ENDPOINT OF TRETINOIN GEL MICROSPHERE, 0.08% (AMNEAL PHARMACEUTICALS LLC, USA) WITH RETIN-A MICRO® (TRETINOIN) GEL MICROSPHERE 0.08% (VALEANT PHARMACEUTICALS NORTH AMERICA LLC) IN SUBJECTS WITH ACNE VULGARIS.
Primary Objective:
-To evaluate bioequivalence of test Tretinoin Gel microsphere, 0.08% (Amneal Pharmaceuticals LLC) with reference Retin-A Micro® (tretinoin) Gel microsphere 0.08% (Valeant Pharmaceuticals North America LLC) in subjects with Acne Vulgaris. To demonstrate the superiority of the test and reference (active) treatments over placebo in the treatment of subjects with Acne Vulgaris.
Secondary Objective:
-To assess the safety and tolerability of study treatments in subjects with Acne Vulgaris.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 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.Healthy males or non-pregnant, non-lactating females aged ≥ 12 and ≤ 40 years with a clinical diagnosis of acne vulgaris.
- •Subjects aged 12 to 17 years inclusive, must provide 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 (i.e., parent or guardian).
- •3.Subjects must have ≥ 25 non-inflammatory lesions (i.e., open, and closed comedones) AND ≥ 20 inflammatory lesions (i.e., papules and pustules) AND ≤ 2 nodulocystic lesions (i.e., nodules and cysts), at baseline on the face.
- •Note: For the purposes of study treatment and evaluation, these lesions should be limited to the facial treatment area.
- •All facial lesions will be counted, including those on the nose.1 Counts of nodules and cysts will be reported separately and not included in the inflammatory or non-inflammatory lesion counts.
- •Nodulocystic lesions will not be included in the inflammatory lesion count 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 for acne vulgaris during the 12-week treatment period, other than the investigational product.
- •6.Female subjects of childbearing potential (excluding women who are premenarchal, surgically sterilized (by hysterectomy) 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.
- •a.For the purpose of this study the following are considered acceptable methods of birth control: oral or injectable contraceptives, contraceptive patches, Depo-Provera® (stabilized for at least 3 months), NuvaRing® (vaginal contraceptive), Implanonâ„¢ (contraceptive implant), double barrier methods (e.g., condom and spermicide), IUD, tubal ligation, Essure or abstinence with a 2nd acceptable method of birth control should the subject become sexually active.
- •b.Subjects on hormonal contraception must be stabilized on the same type for at least three months prior to enrollment in the study and must not change the method during the study c.
- •A sterile sexual partner is NOT considered an adequate form of birth control.
- •Full hysterectomy or bilateral oophorectomy considered surgically sterile.
- •Tubal ligation is not considered equivalent to female sterilization.
- •7.All male subjects must agree to use acceptable methods of birth control with their partners, from the day of the first dose administration to 30 days after the last dose administration of study drug.
- •Abstinence is an acceptable method of birth control.
- •Female partners should use an acceptable method of birth control as described in criteria 6 8.Subjects must be willing and able to understand and comply with the protocol requirements, 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, 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 of 14 days prior to study entry and must agree not to change make-up brand/type or frequency of use throughout the study.
排除标准
- •1.Female subjects who are pregnant, nursing or planning to become pregnant during study.
- •2.Subjects with a history of hypersensitivity or allergy to tretinoin, retinoids, or any of the study medication ingredients.
- •3.Subjects with presence of any skin condition that would interfere with the diagnosis or assessment of acne vulgaris (e.g., on the face: rosacea, dermatitis, psoriasis, squamous cell carcinoma, eczema, acneiform eruptions caused by medications, steroid acne, steroid folliculitis, or bacterial folliculitis.
- •4.Subjects with excessive facial hair (e.g., beards,sideburns,moustaches,etc.)that would interfere with diagnosis or assessment of acne vulgaris.
- •5.Subjects with a baseline irritation score of 3 is equal to severe (marked, intense).
- •6.Subjects who have used within 6 months prior to baseline or use during the study of oral retinoids (e.g.,Accutane®) or therapeutic vitamin A supplements of greater than 10,000 units per day (multivitamins are allowed).
- •7.Concomitant use planned to use of mega-doses of certain vitamins (such as mega-doses of vitamin D greater than 2000 IU per day, vitamin B6 greater than 2 mg or vitamin B12 greater than 1 mg per day), haloperidol, halogens such as iodide and bromide, lithium, hydantoin and phenobarbital.
- •8.Subjects with planned unprotected and intense UV exposure during the study (mountain sports, UV radiation, sunbathing, etc.).
- •9.Use of anti-pruritic, including antihistamines, within 24 hours of baseline visit.
- •10.Subjects who have had laser therapy, electrodessication, and phototherapy (e.g., ClearLight®) to the facial area within 6 months prior to study entry.
- •11.Subjects who have received radiation therapy and/or anti-neoplastic agents within 3 months prior to baseline.
- •12.Subjects who have used estrogens or oral contraceptives for less than 3 months prior to baseline.
- •13.Subjects who have used any of the following procedures on the face within 1 month prior to baseline or use during the study: a.
- •cryodestruction or chemodestruction, b.
- •dermabrasion, c.
- •photodynamic therapy, d.
- •acne surgery, e.
- •intralesional steroids, or f.
- •X-ray therapy.
- •14.Subjects who have used any of the following treatments within 1 month prior to baseline or during the study: a.
- •spironolactone b.
- •systemic steroids, c.
- •systemic antibiotics, d.
- •systemic treatment for acne vulgaris, or e.
- •systemic anti-inflammatory agents.
- •If subject uses a systemic anti-inflammatory product during the study, the Principal Investigator (PI) will judge if this protocol violation is clinically significant, f.
- •have taken any drugs that lower the immune system.
- •topical steroids, b.
- •topical retinoids, c.
- •topical acne treatments including over-the-counter preparations d.
- •topical anti-inflammatory agents, or e.
- •topical antibiotics.
- •16.Subjects who have done wax depilation of the face within 14 days prior to baseline.
- •17.Subjects who have had cosmetic procedures (e.g., facials) which may affect the efficacy and safety profile of the investigational product within 14 days prior to study entry.
- •19.Subjects with eczematous skin.
- •Subjects who have unstable medical disorders that are clinically significant or have life-threatening diseases, or other medical condition that, in the investigator’s opinion, would place the study subject at undue risk by participation or could jeopardize the integrity of the study evaluations.
- •21.Subjects who engage in activities that involve excessive or prolonged exposure to sunlight or weather extremes, such as wind or cold.
- •22.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).
- •23.Subjects who have participated in an investigational drug study (i.e., subjects treated with an investigational drug) within 30 days prior to baseline.
- •Subjects participating in non-treatment studies such as observational studies or registry studies can be considered for inclusion.
- •24.Subjects who have been previously enrolled in this study.
- •25.Subjects who are members of the same household with subjects participating or previously enrolled in this study.
结局指标
主要结局
1 Mean percent change from baseline to week 12 in the inflammatory (papules and pustules) lesion count.
时间窗: Baseline to 12-Week Treatment period
2 Mean percent change from baseline to week 12 in the Noninflammatory (open and closed comedones) lesion count..
时间窗: Baseline to 12-Week Treatment period
次要结局
- 1 Proportion of subjects with a clinical response of IGA score at week 12 compared to baseline.(2 The superiority of the test & reference (active) treatments over placebo (vehicle).)
研究者
Mr Lokesh Chaudhari
Catawba Research India Pvt. Ltd
研究点 (21)
Loading locations...
相似试验
尚未招募
3 期
VAG Versus Standard Chemotherapy With FLT3 Inhibitor in Adult Patients With FLT3-Mutated AMLNCT07407140Institute of Hematology & Blood Diseases Hospital, China300
招募中
3 期
A clinical trial to evaluate the safety and immunogenicity of tetanus vaccine in healthy pregnant womenCTRI/2025/07/090196Human Biologicals Institute132
尚未招募
2 期
To compare Nidigdhikadi Yoga versus Shatyadi Churna in Bronchial AsthmaCTRI/2025/12/098830Institute for Ayurved Studies & Research Shri Krishna AYUSH University66
招募中
3 期
Study to evaluate efficacy and safety of Human normal immunoglobulin given in veins in patients with Immune thrombocytopenia (Low levels of the cells that help blood clot)CTRI/2025/08/093411Bharat Serums and Vaccines Ltd30
已完成
Unknown
This is a clinical trial to evaluate the efficacy, safety and tolerability of CurcuBoost® when administered with standard of care and compared to standard of care alone in participants with osteoarthritis of knee joints.CTRI/2025/02/081342Sunpure Extracts Private Limited50