“A Multicentric, Randomized, Prospective, Double Blind, Parallel Group, Comparative and Phase III Clinical Study to Evaluate the Efficacy and Safety of Ozenoxacin Lotion 2% w/v in the Treatment of Patients with Acne Vulgaris.â€
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 230
- 试验地点
- 16
- 主要终点
- Proportion of patients in each treatment group achieving “success†at Week 12.
研究概览
简要总结
Thistrial is a multicentric, randomized, prospective, double blind, parallel group,comparative and phase III clinical study to evaluate the efficacy and safety ofOzenoxacin Lotion 2% w/v in the treatment of patients with acne vulgaris.
Patientswho are willing and able to participate in the study will sign and date theInformed Consent Form on the day of screening / baseline visit (Visit 1).During this screening period, patients who are willing to give consent will beevaluated for all the eligibility criteria. Eligible patients (male or female) agedbetween 18 to 65 years (both inclusive), who have a score of 2 (mild) or 3 (moderate) on the Investigator’sGlobal Assessment (IGA) at the screening / baseline visit, facial acne inflammatorylesion (papules and pustules) count of at least 20, facial acnenon-inflammatory lesion (open and closed comedones) count of at least 25 andtwo or fewer facial nodulocystic lesions will be considered for thestudy.
After confirming the inclusion/exclusion criteria thesubject will be randomized and provided with study medication at randomizationvisit. Subjects will be provided with patient diary at randomization visit,which need to be brought along with in each subsequent visit till the lastvisit. Follow up visits will be done on week 2/day 14(±2), week 4/day 28(±2), week8/day 56(±2) and week 12/day 84(±2) (Final Visit) of treatment to assess efficacyand safety.
Patientswill be assigned to either of the three arms i.e., Arm A or Arm B or Arm C consistingof Ozenoxacin Lotion 2% w/v or Benzoyl Peroxide Gel 2.5% w/w or Placebo Lotion.Patients will be advised to apply an appropriate amount of study medicationonce a day to the affected area around same time every day for 12 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Male or female patients aged between 18 to 65 years (both inclusive) with a clinical diagnosis of acne vulgaris with facial involvement.
- •Patient must have a score of 2 (mild) or 3 (moderate) on the Investigator’s Global Assessment (IGA) at the screening / baseline visit.
- •Patients with facial acne inflammatory lesion (papules and pustules) count of at least
- •Patients with facial acne non-inflammatory lesion (open and closed comedones) count of at least
- •Patients with two or fewer facial nodulocystic lesions.
- •Women of childbearing potential (WOCBP) must be using an acceptable method of contraception to avoid pregnancy throughout the study.
- •WOCBP must have a negative urine pregnancy test at screening / baseline visit.
- •Patients agree not to use any product on the face during the entire course of study except for non-medicated, investigator-approved cleanser, sunscreen, face wash and make-up.
- •Subjects should continue to use these investigator-approved products for the duration of the study and should avoid any changes in these consumer products.
- •Patients willing to comply with the protocol requirements throughout the study.
排除标准
- •Patients with known or suspected hypersensitivity to quinolone antibacterial agents.
- •Patients with the 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).
- •Patients with excessive facial hair (e.g., heavy beards or moustaches), facial tattoos or facial disfigurement that would interfere with diagnosis or assessment of acne vulgaris.
- •Treatment with the following products: a) Topical acne treatments (retinoids, antibiotics, Benzoyl Peroxide, Azelaic Acid, Resorcinol, salicylates, α-hydroxy/glycolic acid), or other topical facial medication (antifungals, steroids, anti-inflammatories) on the treatment area in the 14 days prior to the baseline visit, including prescription and non-prescription products.
- •b) Systemic corticosteroids, systemic acne treatments including systemic antibiotics used for treatment of acne, potential photosensitizing agents (thiazides, phenothiazines), Spironolactone, Flutamide, or immunosuppressant drugs in the 30 days prior to the baseline visit.
- •c) Systemic retinoid use (including high dose vitamin A > 10,000 units per day) in the 180 days prior to the baseline visit.
- •d) Undertaken certain facial procedures such as chemical peel, laser treatment, photodynamic therapy, acne surgery, cryodestruction or chemodestruction, x-ray therapy, intralesional steroids, dermabrasion, or depilation (except eyebrow shaping) in the 30 days prior to the baseline visit.
- •After the subject is enrolled in the study, eyebrow shaping (except for tweezing) is prohibited.
- •e) Treatment with a medication or procedure that, in the opinion of the investigator, would put the subject at unacceptable risk for participation in the study or may interfere with evaluations in the study.
- •Patients with Estimated glomerular filtration rate (eGFR) <60 mL/min/1.73 m2 [using the Modification of Diet in Renal Disease (MDRD) equation] at screening.
- •Patients with clinically significant impaired hepatic function (SGOT & SGPT more than 3X the UNL and/or Total bilirubin more than 1.5X the UNL) at screening.
- •Patients with uncontrolled hypertension with sitting systolic BP ≥ 160 mmHg and/or diastolic BP ≥ 100 mmHg at screening.
- •Female patients who are of childbearing potential and who are neither surgically sterilized nor willing to use reliable contraceptive methods (like hormonal, barrier methods or intrauterine device).
- •Any abnormality on 12-lead ECG at screening that in the opinion of the investigator is clinically significant and is judged as potential risk for patient’s participation in the study.
- •Subject has a history of experiencing significant burning or stinging when applying any facial treatment (e.g., make-up, soap, masks, washes, sunscreens, etc.) to their face.
- •Patients who have used estrogens or oral contraceptives within 4 weeks prior to randomization.
- •Patients with a serious and/or chronic medical condition such as chronic or active liver disease, renal impairment, heart disease, severe respiratory disease, rheumatoid arthritis, current malignancies, immunocompromised conditions, or any other disease that, in the opinion of the investigator, would interfere with the study or place the subject at unacceptable risk.
- •Patients with a history of substance abuse or dependence that in the opinion of the Investigator is considered to interfere with the patient’s participation in the study.
- •Patients with concurrent participation in another clinical trial or any investigational therapy within 90 days prior to signing informed consent.
- •Patients currently taking any of the prohibited medications(s) and inability/unwillingness to discontinue them for the entire study period.
- •Suspected inability or unwillingness to comply with the study procedures.
- •Patient with any condition which, in the judgment of the Investigator, may render the patient unable to complete the study or which may pose a significant risk to the patient.
结局指标
主要结局
Proportion of patients in each treatment group achieving “success†at Week 12.
时间窗: At Visit 6 [Week 12 / Day 84 (±2)].
次要结局
- Change from baseline to week 12 in non-inflammatory lesion (open and closed comedones) count.(At Screening/baseline visit,)
- Change from baseline to week 12 in inflammatory lesion (papules and pustules) count.(At Screening/baseline visit,)
- Changes in clinical laboratory parameters from baseline to end of the study visit (week 12).(At Screening/baseline visit and)
- Adverse events / serious adverse events(reported during the study.)