A clinical study to evaluate Safety, In-Use Tolerability and Efficacy of HTSS-052203 in reducing the facial dark spots in Healthy Adult Subjects.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- 2) Assessment of skin pigment using 9-point scale.
研究概览
简要总结
Thisis an open label, single-arm, clinical study to evaluate safety, in-usetolerability and efficacy of HTSS-052203in healthy adult human subjects with facial dark spots (suntan, blemishes,sunspots and age-spots) and oily skin.
Thepotential subjects will be screened as per the inclusion and exclusion criteriaonly after obtaining written informed consent from the subjects.
Beforeentering the facility, at security check-post, subjects will be asked for pre-entryscrutiny check for COVID-19 symptoms. Study can be conducted in multiplebatches (set of subjects) in order to follow the norms of covid-19restrictions.
Alleligible subjects will undergo clinical evaluation by Dermatologist, instrumentevaluation and subjective evaluation. Safety will be assessed throughout thestudy by monitoring of adverse events.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 55.00 Year(s)（—）
- 性别
- All
入选标准
- •Subject has at least 2 dark spots on the face (suntan, blemishes, sunspots and age-spots).
- •Preferably equal number of subjects will be recruited in all indications.
- •Subjects with mild to moderate dark spots as per Investigator global assessment (IGA).
- •Subjects with oily skin having Sebumeter measurement > 180 (μg/cm2).
排除标准
- •Subjects having any active dermatological skin diseases (e.g., psoriasis, atopic dermatitis, rosacea etc.), that might interfere with clinical assessments.
- •Subjects who are receiving topical or systemic treatments / undergoing skin lightening treatment.
- •Subjects receiving medications (e.g., steroids or antihistamines) which would compromise the study.
- •Subjects with chronic illness which may influence the cutaneous state.
- •Subjects having history of diabetes, acute cardiac and circulatory diseases, HIV, hepatitis.
- •Subjects using other marketed anti-acne/anti-aging/skin lightening products during the study period or in the past 6 weeks.
结局指标
主要结局
2) Assessment of skin pigment using 9-point scale.
时间窗: Day 01 (before application & after application), Day 07, Day 14, Day 21 and Day 282) Assessment of skin pigment using 9-point scale. | 3) Assessment of dark spots using Mexameter. | 4) Assessment of skin sebum level using Sebumeter
3) Assessment of dark spots using Mexameter.
时间窗: Day 01 (before application & after application), Day 07, Day 14, Day 21 and Day 282) Assessment of skin pigment using 9-point scale. | 3) Assessment of dark spots using Mexameter. | 4) Assessment of skin sebum level using Sebumeter
4) Assessment of skin sebum level using Sebumeter
时间窗: Day 01 (before application & after application), Day 07, Day 14, Day 21 and Day 282) Assessment of skin pigment using 9-point scale. | 3) Assessment of dark spots using Mexameter. | 4) Assessment of skin sebum level using Sebumeter
1) Assessment of dark spots using Investigator global assessment (IGA).
时间窗: Day 01 (before application & after application), Day 07, Day 14, Day 21 and Day 282) Assessment of skin pigment using 9-point scale. | 3) Assessment of dark spots using Mexameter. | 4) Assessment of skin sebum level using Sebumeter
次要结局
- Assessment of skin elasticity using Cutometer(Day 01 (before application & after application), Day 07, Day 14, Day 21 and Day 28)
- Assessment of Product Response Index (Perception about Product) after product usage(Day 28)
- Assessment of uneven skin tone using Felix Von Luschan Skin colour chart(Day 01 (before application & after application), Day 07, Day 14, Day 21 and Day 28)
- Assessment of the colour of dark spot using Chromameter(Day 01 (before application & after application), Day 07, Day 14, Day 21 and Day 28)
- Assessment of Skin radiance using Modified Griffiths Scale(Day 01 (before application & after application), Day 07, Day 14, Day 21 and Day 28)
- Assessment of Skin gloss using Skin-Glossymeter(Day 01 (before application & after application), Day 07, Day 14, Day 21 and Day 28)
- Assessment of Skin Moisturization using Corneometer / MoistureMeterSC(Day 01 (before application & after application), Day 07, Day 14, Day 21 and Day 28)
- Assessment of Subject Satisfaction Questionnaire after product usage(Day 01 (before application & after application), Day 07, Day 14, Day 21 and Day 28)
- Assessment of skin barrier function by measuring Transepidermal Water Loss (TEWL) using TEWAmeter / Vapometer(Day 01 (before application & after application), Day 07, Day 14, Day 21 and Day 28)
- Assessment of dark spots and skin texture (roughness) using 3D analysis system(Day 01 (before application & after application), Day 07, Day 14, Day 21 and Day 28)