ASSESSMENT OF TOPICAL FORMULAE FOR THEIR EFFICACY ON SKIN ACNE RELATED IMPERFECTIONS THROUGH INSTRUMENTAL AND DERMATOLOGIST ASSESSMENT OVER 8 WEEK DAILY 1X 2X HOME USAGE
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 280
- 试验地点
- 1
- 主要终点
- 1.To compare the efficacy of four topical formulae on acne prone and oily skin of subjects as determined by below mentioned parameters:
研究概览
简要总结
The purpose of the trial is to check the efficacy of acne products on acne oily skin of Indian males and females of age 18 years to 35 years
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- 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
- •Healthy Male & Female subjects aged 18 to 35 years (both included) (subjects to be enrolled in equal ratio as per gender).
- •Subjects having skin phototype IV and V (Fitzpatrick) (subjects to be enrolled in equal ratio as per phototype) 3) Subjects having body Mass Index in the range of 18 to 25 kilogram per square meter (BMI can be relaxed to 30 kilogram per square meter in case of recruitment challenges) 4) Subjects having oily skin type according to investigator 5) Subjects with mean sebum casual level on forehead less than100 microgram/Square Centimeter 6) Subjects presenting with mild (grade 2) to moderate acne (grade 3) severity on an IGA scale from 0 to 4 according to the investigator.
- •Subjects presenting acne lesion count: More than 10 to less than 25 inflammatory acne lesions on whole face (Forehead, cheeks, nose, jawline and chin).
- •(mean value without nose around 15 to 16) More than 25 to less than 00 non-inflammatory/comedonal acne lesions on Forehead, cheeks, nose, jawline and chin.
- •(mean value without nose around 60 to 65) max 2 nodule (less than 1cm) 8) Subjects having a well-defined homogenous PIH spot of less 3mm on whole face with adjacent non-pigmented skin.
- •Subjects willing not to go for UV sessions/sun tanning/sun-bathing during the study duration.
- •Subjects agreeing to use only the supplied washout product and investigational product provided during the study.
- •Subjects informed about the study objectives and procedures and able to understand them.
- •Subjects willing and able to fulfil the study requirements and schedule.
- •Subjects willing to provide written informed consent and are able to understand English or Hindi.
- •Subjects willing to avoid oily greasy junk food and high sugar food items, as much as possible during the study period.
- •Subjects willing not to apply hair oil and wash their hair within 48 hours prior to the assessment visit.
- •Subjects willing to not to expose themselves in sun and must carry umbrella/cap/hat if going out.
- •Female of childbearing potential willing to undergo urine pregnancy test [self-declared by subject on screening visit and test to be done on Visit 2 (Baseline visit) Visit 7 Visit 8 & Visit 9 18) Female of childbearing potential, who is not sexually active or who is using an effective contraceptive method for at least one month before the beginning of the study, and throughout the study.
排除标准
- •Subjects who are pregnant or lactating or who are planning to become pregnant during the study.
- •Subjects who have used anti-acne products within the last 30 days 3) Subjects who have only noticed an increase of acne due to protective face mask usage 4) Subjects that are under the treatment/care of a dermatologist 5) Subjects who have started, stopped or changed his/her hormonal treatment (including contraceptive pill) in the previous one month prior to the study 6) History of allergies, hypersensitivity or any serious reactions to any cosmetic products 7) Any significant skin pathology in the test areas, like rosacea, or eczema.
- •Any significant medical condition that would interfere with the participation in the study, as per the opinion of the Investigator 9) Any concomitant medical/surgical condition or using medication which may harm the subject or may interfere with the study assessments, as per opinion of the Investigator 10) Any dermatological procedure on the test areas (laser peel, dermabrasion etc.) taken 4 weeks before the start of the study and during the study 11) Subject reported or planning to sun bathe or to overexpose to UV light (mountains sports phototherapy, tanning salon use) for aesthetic or therapeutic reason the month before the study start or during the study.
- •Having participated in the last 30 days before screening or currently participating in another clinical study 13) Unable to be contacted by phone in case of emergency.
结局指标
主要结局
1.To compare the efficacy of four topical formulae on acne prone and oily skin of subjects as determined by below mentioned parameters:
时间窗: Visit 1: Day-14 to Day -1 | Visit 2: Day 0 ± 2 days | Visit 2: Day 0 Timm | Visit 3: Day 3±1 day | Visit 4: Day 7±1 day | Visit 5: Day 14± 2 days | Visit 6: Day 21± 2 days | Visit 7: Day 28± 2 days | Visit 8: Day 56± 2 days | Visit 9: Day 70± 2 days
Acne lesion counts (inflammatory & non-inflammatory).
时间窗: Visit 1: Day-14 to Day -1 | Visit 2: Day 0 ± 2 days | Visit 2: Day 0 Timm | Visit 3: Day 3±1 day | Visit 4: Day 7±1 day | Visit 5: Day 14± 2 days | Visit 6: Day 21± 2 days | Visit 7: Day 28± 2 days | Visit 8: Day 56± 2 days | Visit 9: Day 70± 2 days
Clinical grading of Acne using IGA scale.
时间窗: Visit 1: Day-14 to Day -1 | Visit 2: Day 0 ± 2 days | Visit 2: Day 0 Timm | Visit 3: Day 3±1 day | Visit 4: Day 7±1 day | Visit 5: Day 14± 2 days | Visit 6: Day 21± 2 days | Visit 7: Day 28± 2 days | Visit 8: Day 56± 2 days | Visit 9: Day 70± 2 days
Prevention of PIH by monitoring the evolution of 6-8 target inflammatory lesions (6-8papules &/or 2 pustules) for residual pigmentation.
时间窗: Visit 1: Day-14 to Day -1 | Visit 2: Day 0 ± 2 days | Visit 2: Day 0 Timm | Visit 3: Day 3±1 day | Visit 4: Day 7±1 day | Visit 5: Day 14± 2 days | Visit 6: Day 21± 2 days | Visit 7: Day 28± 2 days | Visit 8: Day 56± 2 days | Visit 9: Day 70± 2 days
Evaluation of sebum casual level and sebum excretion rate using Sebumeter SM 815®.
时间窗: Visit 1: Day-14 to Day -1 | Visit 2: Day 0 ± 2 days | Visit 2: Day 0 Timm | Visit 3: Day 3±1 day | Visit 4: Day 7±1 day | Visit 5: Day 14± 2 days | Visit 6: Day 21± 2 days | Visit 7: Day 28± 2 days | Visit 8: Day 56± 2 days | Visit 9: Day 70± 2 days
Redness around acne by Dermat & by using Antera 3D®imaging.
时间窗: Visit 1: Day-14 to Day -1 | Visit 2: Day 0 ± 2 days | Visit 2: Day 0 Timm | Visit 3: Day 3±1 day | Visit 4: Day 7±1 day | Visit 5: Day 14± 2 days | Visit 6: Day 21± 2 days | Visit 7: Day 28± 2 days | Visit 8: Day 56± 2 days | Visit 9: Day 70± 2 days
Clinical grading for reduction in redness around two target inflammatory lesions (L&R).
时间窗: Visit 1: Day-14 to Day -1 | Visit 2: Day 0 ± 2 days | Visit 2: Day 0 Timm | Visit 3: Day 3±1 day | Visit 4: Day 7±1 day | Visit 5: Day 14± 2 days | Visit 6: Day 21± 2 days | Visit 7: Day 28± 2 days | Visit 8: Day 56± 2 days | Visit 9: Day 70± 2 days
次要结局
- 1.To compare the efficacy of topical formulae in reducing and preventing pigmentary spots by below mentioned parameters:(Evaluation of Density of Pigmentary spots (PIH spots only) using the Indian Atlas.)
研究者
Dr Pranami Kashyap
CIDP Biotech India Pvt. Ltd.