A Post-marketing Clinical Investigation Study to assess safety and efficacy of Hydrozid Spray for cryotherapy in superficial epidermal and dermal lesions.
试验速览
- 阶段
- Unknown
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 8
- 主要终点
- 1.The incidence of adverse events (AEs) and severe adverse events (SAEs), considered as related to the study treatment.
研究概览
简要总结
The study will be conducted in patients diagnosed with superficial epidermal and dermal lesions. Patients will be assessed for safety and efficacy at day 7, day 14, day 30(±2) days and 60(±2) after the cryotherapy.
The primary outcome will evaluate the incidence of adverse events related to study treatment and Assessment of local skin reactions (LSRs), pain assessment by VAS scale just after therapy, 2 hrs, 4 hrs, 8 hrs and on 24hrs after treatment and incidence rate of pigmentation and scarring following study treatment
The secondary outcome evaluates Percentage of patients with total disappearance of skin lesions at end of study visit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
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 patientsof age between 18 to 65 years both inclusive.
- •Patient has atleast one or more epidermal or dermal skin lesions (e.g., Verruca plantaris, Verruca vulgaris, Verruca plana, Keratosis seborrhoica, Lentigo (facial), Lentigo (non-facial), Acrochordon (skin tag),), Keratosis actinica (facial), Keratosis actinica (non-facial) Molluscum contagiosum )lesions of diameter bêtween ≥ 5 mm and ≤ 10 mm in an area suitable for treatment.
- •Patient is willing to have digital photographs taken of the treatment area and agrees to use ofphotographs for presentation, educational, or marketing purposes.
- •Patients who are willing to sign informed consent for participation in the study and willing to adhere to all protocol procedures.
排除标准
- •Physician prescribed medical or surgical treatment, or use of over-the-counter products to alter skin colour, in the area of intended treatment in the previous 1 month (e.g., hydroquinone, corticosteroids, laser surgery)
- •Artificial tanning in the area of intended treatment within 1 month (e.g., spray, lotion, tanning bed) or intention to use artificial tanning within the follow-up period
- •Open wounds, cuts and delicate or eczematous skin,Scars or tattoos in the location of the treatment sites
- •History of melanoma.
- •Known history of illness or adverse reaction to cold insult (e.g..cryoglobulinaemia, Raynaud’s disease, cold urticaria, blood dyscrasias, or uncertain diagnosis).
- •Patients who have impaired healing eg due to diabetes, vascular disease, vitamin A deficiency, hyperthyroidism and hypothyroidism.
- •Patients who took immunosuppressant drugs such as oral corticosteroids within the past three months.
- •Patients who have autoimmune diseases, eg SLE, dermatomyositis, scleroderma and other diseases.
- •Patient has a history of sensitivity to any of the ingredients in the study medications.
- •Patients who cannot tolerate cryotherapy for their own reasons.
- •Patient has any current skin disease (e.g., Psoriasis, atopic dermatitis, eczema, sun damage), or condition (e.g., sunburn, excessive hair, open wounds) that, in the opinion of the investigator,might put the Patient at undue risk by study participation or interfere with the study conduct or evaluations.
- •Inability or unwillingness to comply with the study requirements.
- •Female Patients who are pregnant or lactating or planning to become pregnant during the study period.
- •Females who are not ready to use acceptable contraceptive methods during the course of study.
- •History of alcohol abuse and smoking.
- •Current enrollment in a clinical study of any other unapproved investigational drug or device within 30 days prior to signing informed consent.
结局指标
主要结局
1.The incidence of adverse events (AEs) and severe adverse events (SAEs), considered as related to the study treatment.
时间窗: 1.60±2 Days | 2.60±2 Days | 3.24 Hours | 4.60±2 Days
2.Assessment of local skin reactions (LSRs)
时间窗: 1.60±2 Days | 2.60±2 Days | 3.24 Hours | 4.60±2 Days
3.Pain assessment by VAS scale just after therapy, 2 hrs, 4 hrs, 8 hrs and 24hrs after treatment.
时间窗: 1.60±2 Days | 2.60±2 Days | 3.24 Hours | 4.60±2 Days
4.Incidence rate of pigmentation and scarring following study treatment as assessed by Vancouver Scar Scale.
时间窗: 1.60±2 Days | 2.60±2 Days | 3.24 Hours | 4.60±2 Days
次要结局
- Percentage of patients with total disappearance of skin lesions at the end of study visit(60±2 Days)