A Multicentric, assessor-blind, randomized, active controlled, parallel design study comparing efficacy and safety of clobetasol propionate topical foam 0.05% vs. clobetasol propionate lotion 0.05% in patients with mild to moderate plaque type psoriasis (scalp and non-scalp)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 232
- 试验地点
- 14
- 主要终点
- Percentage of patients with Investigator’s static global assessment scores of 0 or 1 at week 2.
研究概览
简要总结
Psoriasis is a chronic, inflammatory skin disorder that causes physical discomfort and psychological distress in 1-5% of the population worldwide. Clobetasol Propionate (CP) is a synthetic super-potent fluorinated topical corticosteroid, used for the treatment of psoriasis and available in variety of formulations such as ointments, creams, lotions, solutions and gels at a concentration of 0.05% regardless of vehicle. Foam dosage form is newer and excellent for topical application of medication. Due to unique film forming and breaking characteristics, foam can be easily transferred from the container to the intended skin application site. Several studies reported that patient gives higher preference to foam than other traditional dosage form like cream or ointment due to ease of application, easy and uniform spreading on skin surface, less stickiness, less greasy feeling, quick drying after application and relatively less residue on skin surface after application. The present study is planned to compare the efficacy and safety of Torrent’s clobetasol propionate topical foam 0.05% with clobetasol propionate lotion 0.05% in patients of mild to moderate plaque type psoriasis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Permuted block randomization, fixed
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Male and female patients of age 18 years or older.
- •2.Patients with mild to moderate plaque-type psoriasis, as defined by ISGA score of 2-3 at enrolment involving ≤10 % of total body surface area.
- •3.Patients must have a target lesion (>2 cm2) with a score of 2-3 (on a scale of 0 to 5) for each of erythema, scaling and plaque thickness.
- •4.Patients with ability and willingness to follow the study procedures attend all scheduled visits and successfully complete the study.
- •5.Patients willing to give informed consent.
排除标准
- •1.Patients with known allergy or sensitivity to clobetasol or other topical corticosteroids or any other component of investigational formulation.
- •2.Patients whose psoriasis involves the face, nails, palms, soles or intertriginous sites.
- •3.Severe, uncontrolled manifestation of any disease including psoriasis.
- •4.Use of systemic antipsoriatic therapy (e.g., corticosteroids, retinoids, methotrexate, psoralen and ultraviolet light, cyclosporine) within the past 4 weeks 5.Patients who have taken or currently on biologics treatment such as e.g., alefacept, etanercept, adalimumab.
- •6.Use of topical treatment which have a known beneficial effect on psoriasis, including but not limited to corticosteroid, retinoids, vitamin D derivatives, tar or anthralin within the past 2 weeks.
- •7.Introduction or change in dosage of systemic medications for other medical conditions which are known to affect psoriasis (e.g., lithium, β-blockers etc.) within the past 4 weeks.
- •8.The expectation of exposure to strong sunlight or UV therapy during the course of the study; or any condition that, in the judgment of the investigator, would put the patient at unacceptable risk for participation in the study.
- •9.Patients who are known seropositive cases of HIV, Hepatitis B or Hepatitis C.
- •10.History of malignancy in last 5 years.
- •11.Current drug or alcohol abuse.
- •12.Patient with clinically significant abnormal laboratory investigation.
- •13.Use of any investigational drug or device therapy within the past 4 weeks.
- •14.Pregnant women, women who are breast feeding or women of reproductive potential who are neither surgically sterilized nor willing to use effective contraceptive methods during the course of the study.
- •15.Men wishing to father a child during the course of the study or not ready to use adequate means of contraception throughout the study.
- •16.Patient who in the opinion of the investigator would not be suitable candidate for participation in the study.
结局指标
主要结局
Percentage of patients with Investigator’s static global assessment scores of 0 or 1 at week 2.
时间窗: Screening, Day 0, Week 1 and Week 2
次要结局
- Percentage of patients with Investigator’s static global assessment scores of 0 or 1 in scalp and non-scalp psoriasis groups at week 2(Screening, Day 0, Week 1 and Week 2)
- Mean change in scores of target lesion signs of psoriasis (erythema, scaling, plaque thickness) and pruritus from baseline to week 2(Screening, Day 0, Week 1 and Week 2)
- Percentage of patients with Subject’s global assessment score of 0 or 1 at week 2(Day 0, Week 1 and Week 2)
- Comparison of mean vehicle acceptance score between treatment groups at week 2(Week 2)