A clinical study to evaluate the efficacy of Lightinderm device augmented spot corrector serum use in reducing the hyperpigmented spots in healthy female subjects
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 43
- 试验地点
- 1
- 主要终点
- To evaluate & compare the efficacy of the Lightinderm device augmented spot corrector serum in providing a reduction in the visibility of spots (intensity) & hyperpigmentation while enhancing the skin luminosity and improving skin tone evenness as per dermatological assessments and non-invasive instruments (Spectrophotometer, VISIA CR, Antera) in 8 weeks when compared to the baseline.
研究概览
简要总结
Healthy female subjects who meet the inclusion andexclusion criteria will be enrolled upon obtaining informed consent, with aninitial screening of 43 subjects aiming for 35 to complete the study. Followingenrollment, subjects will cleanse their faces and acclimatize before undergoingbaseline dermatological and non-invasive assessments, including instrumental and dermatological evaluations.Subsequently, subjects will receive training in using the test device, with thefirst application supervised by designated personnel. Throughout the study,subjects will utilize the test device with spot corrector serum cartridgesprovided, attending compliance checks and follow-up visits, where usedcartridges will be replaced, and additional serum dispensed. The study willconclude at week 8, at which point the device, both used and unused cartridges,will be returned, and subjects will be given day cream and sunscreen. Subjectsmust adhere to provided skincare products exclusively and attend week 1, week 4 andweek 8 assessments as instructed.
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 50.00 Year(s)（—）
- 性别
- Female
入选标准
- •1.Female adult subjects in general good health as determined from a recent medical history, general physical examination, dermatological assessment.
- •2.Subjects in the age group of 18-50 years (both ages inclusive).
- •3.Subjects with various skin types, including normal, dry, oily, and combination, while excluding those with sensitive skin.
- •4.Subjects with skin phototype III to VI 5.Subjects presenting with uneven skin tone and hyperpigmented spots on the face with a subset of 10 subjects with melasma 6.Subjects free of excessive hair, acne, cuts, abrasions, fissures, wounds, lacerations, or any other active skin conditions on the face as determined by the dermatologist.
- •7.Subject who agrees not to use any other product/treatment/home remedy/ except the provided product on their face during the study period other than the test and additional products of the study.
- •8.Subjects who agree not to carry out bleaching or any other procedures including facial etc.
- •on face during the study period.
- •9.Subjects who agree not to expose to excessive sun light (sun exposure not more than half an hour daily and during that time use of umbrella to cover face).
- •10.Subjects willing to give a voluntary written informed consent, photography release and agree to come for regular follow-up.
- •11.Subjects willing to abide by and comply with the study protocol.
排除标准
- •1.Subject with any other signs of significant local irritation or skin disease.
- •2.Subject currently taking any medication, which the Investigator believes may influence the interpretation of the data.
- •3.Subject having clinically significant systemic or cutaneous disease, chronic illness or had major surgery in the last year.
- •4.Subjects who do not agree to remove all jewellery on/around face (e.g., necklace, earrings, if possible nose ring), during VISIA CR imaging.
- •5.Subjects having hair style which covers almost the entire forehead 6.Subjects undergoing any treatment of any skin condition on their face 7.Subjects not willing to discontinue other topical facial products.
- •8.Subject allergic or sensitive to bar, cleansing products, cosmetics, creams/lotions, artificial jewellery or anything else.
- •9.Subjects who are pregnant and lactating 10.Subjects on any medical treatment either systemic/topical in the past 1 month or currently taking medication including food supplements.
- •11.Subjects with skin allergy, history of atopic dermatitis or psoriasis 12.Subjects who have participated in any other clinical trial in the last 3 months.
- •13.Subjects who have undergone treatment with Botox/filler /bio stimulatory molecules injection in the past six months.
结局指标
主要结局
To evaluate & compare the efficacy of the Lightinderm device augmented spot corrector serum in providing a reduction in the visibility of spots (intensity) & hyperpigmentation while enhancing the skin luminosity and improving skin tone evenness as per dermatological assessments and non-invasive instruments (Spectrophotometer, VISIA CR, Antera) in 8 weeks when compared to the baseline.
时间窗: T0, Week 1, Week 4, Week 8
次要结局
- 1.To evaluate improvement in skin clarity, skin texture (exploratory)(2.To evaluate efficacy, safety & skin tolerance of test products in a long-term use for 8 weeks by dermatological evaluation and subjective feedback)