CTRI/2024/10/075991已完成不适用
A Randomized, Double-Blind, Multi-Center, Parallel Study to Evaluate the Bioequivalence using Clinical Endpoint of Permethrin Cream, 5 percentage of KLM Laboratories Pvt. Ltd., India to Permethrin Cream, 5 percentage of Padagis Israel Pharmaceuticals Ltd in Subjects with scabies.
KLM Laboratories Pvt.Ltd.12 个研究点 分布在 1 个国家目标入组 250 人开始时间: 2024年11月18日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 250
- 试验地点
- 12
- 主要终点
- The proportion of patients clinically cured at the end of study Day 28, defined as subject either Cured or Improved.
研究概览
简要总结
Permethrin is considered the drug of choice for the treatment of scabies. It is safe for use in adults and children 2 years and older. One or two applications, about a week apart may be necessary to eliminate all mites and eggs on the patient’s body.This is a Randomized, double-blind, multi-center, parallel study to evaluate the bioequivalence using clinical endpoint of Generic Product to RLD, 5% (Padagis Israel Pharmaceuticals Ltd) in subjects with scabies. Each subject shall be randomly assigned in a 1:1 ratio to treatment with the test product or reference product.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 2.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Male or non-pregnant, non-lactating female, at least 2 years of age or older.
- •Subject with clinical findings of scabies burrows such as excoriations and inflammatory papules, erythematous papules, etc..
- •Subject with Parasitological confirmation OR positive identification for scabies mites, eggs, or mite fecal matter by microscopic examination of a skin scraping.
- •Subject and,or parent,guardian agree that the subject shall not use any other form of scabies treatment during the duration of the study.
- •Subject OR Subject guardian willing to make every effort to immediately disinfect clothes, towels, and linens and all potentially infected household items upon diagnosis of infestation to prevent reinfestation.
- •All household members with prolonged physical contact with the subject is willing to attend baseline visit and receive allotted treatment by the Investigator in order to prevent reinfestation of the subject enrolled
- •Symptom score of 2 or 3 on a 4 point rating scale of 0-3 for nocturnal itching OR pruritus.
- •Ability to apply or have study product applied as directed to self.
- •If Subject is a child, then parent OR guardian shall apply study product to him OR her.
- •Willing to provide written informed consent or assent, as applicable.
- •For subjects who are considered minors i.e more than 18 completed years the parent or legal guardian shall sign the consent form and the child shall be required to sign a subject assent form, as appropriate.
- •Subject and or parent or guardian shall be willing and able to understand and comply with the requirements of the study.
- •Female Subject of childbearing potential practicing an approved method of contraception that is stable at least 3 months prior to baseline and throughout the study.
- •Acceptable forms of birth control include any of the following
- •hormonal birth control, which must be stable for more than 3 months prior to baseline
- •abstinence subject must use condom plus spermicide if becomes sexually active 3 double barrier method, such as condom plus spermicide and have a negative Urine Pregnancy Test at the time of screening or female subjects of non-childbearing potential.
排除标准
- •Female subjects who are pregnant, lactating, or planning to become pregnant during the study.
- •Skin conditions that could make it difficult to evaluate the extent of an infestation or would present a problem in the evaluation of response to therapy e.g. atopic dermatitis, eczema, contact dermatitis, lichen planus, papular urticaria, seborrheic dermatitis.
- •Use within 4 weeks of baseline visit 1 immunomodulators 2 systemic medications that suppress the immune system 3 topical or oral parasiticides.
- •Use within 2 weeks of baseline visit 1 topical steroids 2 topical or systemic antibiotics
- •Subject with coexisting dermatological disorder that could interfere with the diagnosis and subsequent monitoring of scabies or crusted scabies
- •Known history of irritation or sensitivity to parasiticides.
- •Known allergy or hypersensitivity to permethrin, any synthetic pyrethroid or pyrethrin, plants in the Asteraceae or Compositae family e.g. chrysanthemums, ragweed, marigolds, and daisies
- •Use of any systemic or topical acaricide or ectoparasiticide within one month before Screening.
- •Presence of severe cutaneous bacterial or fungal infections requiring therapy including systemic and topical antibiotics as determined by the Investigator.
- •Subject has signs of a systemic infection or is receiving systemic therapy for an infectious disease.
- •Subjects with an underlying immunodeficient state including prolonged treatment with corticosteroids, immunosuppressive disorders requiring therapy, severe systemic disease and history of HIV infection.
- •Subjects whose close personal contacts shall not or are not willing to comply with standard of care for Scabies management.
- •Subject who are directly employed at the study site and are associated with conduct of this study.
- •Subjects whose household members and close contacts refuse treatment
- •Subjects whose sexual contacts do not agree to restrict prolonged skin to skin contact with non-household members during the study period
- •Subjects with a household member less than 2 years of age
- •Presence of underlying skin disease that would obscure evaluation of the papules and burrows associated with scabies infection as determined by the Investigator.
- •Subjects who in the opinion of the Investigator would be non-compliant with the requirements of the study protocol.
- •Subject with clinically significant unstable medical disorders, life-threatening disease.
- •Subject who has been treated with an investigational product or investigational device within a period of 30 days prior to study enrolment.
结局指标
主要结局
The proportion of patients clinically cured at the end of study Day 28, defined as subject either Cured or Improved.
时间窗: Day 29
次要结局
- The proportion of patients clinically cured at the end of study Day 15, defined as subject either Cured or Improved.(Day 15)
研究者
Dr D Sathish Kumar
G7 Synergon Private Limited
研究点 (12)
Loading locations...
相似试验
招募中
4 期
A Comparative Trial on Scabies Treatments: Topical Permethrin, Oral Ivermectin and Combination of Topical Permethrin and Oral Ivermectin2024-520348-40-00Giuliani S.p.A.156
尚未招募
4 期
A STUDY ON EFFICACY, SAFETY AND TOLERABILITY OF TOPICAL PERMETHRIN VS TOPICAL SPINOSAD IN MANAGEMENT OF SCABIESCTRI/2025/11/097926Dr.Noorain Hamid Khan96
撤回
2 期
Study to Investigate Petosemtamab in Adults With Metastatic Non-Small Cell Lung CancerNCT07353957Merus B.V.180
招募中
1 期
A Phase Ib/II Trial of HS-20110 Combination Therapies in Advanced Colorectal Cancer Patients.CRCNCT07283367Hansoh BioMedical R&D Company502
进行中（未招募）
3 期
司普奇拜单抗治疗结节性痒疹 III 临床研究CTR20241776200