Assessment Of Topical Cleanser Formulae Using Clinical Performance On Skin Acne Imperfection Through Instrumental And Dermatologist Assessment, Over 4 Weeks Daily 2x Home Usage.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 200
- 试验地点
- 1
研究概览
简要总结
This is a mono-centric, randomized, parallel group, placebo-controlled, double blinded, comparative study to evaluate the effectiveness of Topical Cleanser Formulae on Skin Acne Imperfection Through Instrumental And Dermatologist Assessment, Over 4 Weeks Daily 2x Home Usage on adult male and female participants with acne, oily skin and PIH.
The potential participants will be screened as per the inclusion and exclusion criteria only after obtaining written informed consent from the participants.
Total Study Duration: 49 days
· Washout Period: At least 14 Days
· Treatment Period: 28 days from enrollment visit (Day 00)
· Relapse Period: 07 days from the end of treatment (i.e., Visit 06).
All eligible participants 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
- Participant and Investigator 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
- •Participants with skin phototype IV – V (1:1) (Fitzpatrick phototype assessed based on ITA0 value.
- •Measurement Site: Back of the participant) 2) Participants having Body Mass Index in the range of 18 to 25 kg per m
- •(Note: BMI can be relaxed to 30 kg per m2 in case of recruitment challenges).
- •Participants having oily skin type, according to the investigator.
- •Participants with oily skin as assessed by Sebumeter (Sebum casual level on centre of the forehead greater than or equal to 100 microgram per cm2).
- •Participants presenting with mild (grade 2) to moderate acne (grade 3) severity on an IGA scale from 0 to 4, according to the investigator.
- •Participants with PIH Spot 3mm and above.
- •Participants presenting acne lesions count: a.
- •greater than or equal to 10 to less than or equal to 25 inflammatory acne lesions on whole face b.
- •greater than 25 to less than or equal to 100 non-inflammatory acne lesions on whole face.
排除标准
- •Participants with drug induced acne as disclosed by participants.
- •Participants who have used anti acne products in the last 30 days.
- •Participants who are receiving topical or systemic treatments for acne and PIH within the last 30 days.
- •Participants receiving concomitant medications (e.g., steroids or antihistamines)or surgical condition would compromise the study.
- •Participants with chronic illness which may influence the cutaneous state.
- •Participants having any active dermatological skin diseases (e.g., psoriasis, atopic dermatitis, rosacea etc.), that might interfere with clinical assessments.
- •Participant 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.
- •Participants with any pigmentary disorder including freckles and melasma.
研究者
Dr Purva Bambhania
Cliantha Research