To assess the effectiveness of Topical Formulae for their efficacy on skin acne related imperfections through instrumental and dermatologist assessment on mild to moderate acne over 4-week daily 2X usage in healthy adult subjects.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 184
- 试验地点
- 1
- 主要终点
- 1) Dermatological assessment of acne lesions using counting method.
研究概览
简要总结
This is a mono-centric, randomized, parallel group, assessor blinded, comparative study to evaluate the effectiveness of 4 topical formulae on subjects with mild to moderate acne.
The potential subjects will be screened as per the inclusion and exclusion criteria only after obtaining written informed consent from the subjects.
Total Study Duration: 56 days
Washout Period: Atleast 14 Days
Treatment Period: 28 days from enrollment visit (Day 01)
Relapse Period: 14 days from end of treatment (i.e., Visit 06)
All eligible subjects will undergo clinical evaluation by a Dermatologist, instrument evaluation and subjective evaluation. Safety will be assessed throughout the study by assessing the local intolerances and monitoring adverse events.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 35.00 Year(s)（—）
- 性别
- All
入选标准
- •Subjects with skin phototype III.
- •V (Fitzpatrick phototype assessed based on ITA value) 2) Subjects having Body Mass Index in the range of 18 to 25 kg/m
- •Subjects having oily skin type and combination of oily, sensitive. 4) Subjects with mild to moderate acne severity based on IGA scale. 5) Subjects with PIH spot of 3mm & above. 6) Subjects presenting acne lesions count: • more than/equal to 10 to less than/equal to 25 inflammatory acne lesions on whole face • more than 25 to less than/equal to 100 non-inflammatory acne lesions on whole face.
排除标准
- •Subjects who have used anti acne products in the last 30 days.
- •Subjects who are receiving topical or systemic treatments for acne and PIH within last 30 days.
- •Subjects undergoing dermatological procedures for skin lightening or using other marketed skin lightening products during the study period or in the past 6 weeks.
- •Subjects having any active dermatological skin diseases (e.g., psoriasis, atopic dermatitis, rosacea etc.), that might interfere with clinical assessments.
- •Subject having excessive hair, moles, open wounds, cuts, abrasions, irritation symptoms, tattoos, scars, sunburn or any dermatological condition on the test site(s) that can interfere with the reading.
结局指标
主要结局
1) Dermatological assessment of acne lesions using counting method.
时间窗: Screening Visit, Day 01, Day 03, Day 07, Day 14, Day 28 and Day 42.
2) Instrumental assessment of intensity of PIH and bare skin.
时间窗: Screening Visit, Day 01, Day 03, Day 07, Day 14, Day 28 and Day 42.
3) Instrumental assessment of the size of PIH
时间窗: Screening Visit, Day 01, Day 03, Day 07, Day 14, Day 28 and Day 42.
次要结局
- Dermatological assessment of Acne Severity using grading scale(Screening Visit, Day 01, Day 03, Day 07, Day 14, Day 28 and Day 42.)
- Dermatological assessment of Redness around Acne lesion and skin radiance using grading scale(Day 01, Day 03, Day 07, Day 14, Day 28 and Day 42)
- Instrumental assessment of skin sebum level, face hydration, skin barrier function and skin brightening(Day 01, Day 03, Day 07, Day 14, Day 28 and Day 42)
- Instrumental assessment of Redness around acne (a value & redness measurements), acne elevation & sebaceous pores(Screening Visit, Day 01, Day 03, Day 07, Day 14, Day 28 & Day 42.)
- Dermatological assessment of global efficacy and tolerance of products(Day 03, Day 07, Day 14, Day 28 and Day 42.)
- Subjective assessment(Day 01, Day 03, Day 07, Day 14, Day 28 and Day 42.)
研究者
Dr Purva Yadav
Cliantha Research